Ignite Creation Date:
2025-12-25 @ 12:21 AM
Ignite Modification Date:
2026-01-22 @ 1:24 PM
Study NCT ID:
NCT02615158
Status:
COMPLETED
Last Update Posted:
2020-05-12
First Post:
2013-02-11
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Toddler Overweight Prevention Study Among Low-Income Families
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009752', 'term': 'Nutritional Status'}, {'id': 'D011581', 'term': 'Psychological Tests'}, {'id': 'D057207', 'term': 'Child Restraint Systems'}], 'ancestors': [{'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D006304', 'term': 'Health Status'}, {'id': 'D003710', 'term': 'Demography'}, {'id': 'D011154', 'term': 'Population Characteristics'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D015370', 'term': 'Infant Equipment'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D011482', 'term': 'Protective Devices'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mblack@som.umaryland.edu', 'phone': '410-706-2136', 'title': 'Dr. Maureen Black', 'organization': 'University of Maryland School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Data analysis was delayed due to extended period of time for coding the mother-toddler interaction data, related to personnel and funding.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were monitored over the time period that participants were actively participating in the study and assessments (e.g., 12 months for each participant or until the final assessment was completed).', 'description': 'Data Safety Monitoring Committee reviewed records and interviewed project coordinator.', 'eventGroups': [{'id': 'EG000', 'title': 'Maternal Lifestyle (Physical Activity and Nutrition)', 'description': 'A maternal lifestyle intervention focusing on healthy diet and physical activity patterns for mothers.\n\nMaternal Lifestyle (Physical Activity and Nutrition): At each session, mothers will identify a dietary goal for the next session (e.g., reduce soda intake). They will learn to track and evaluate their progress, setting new goals or modifying existing ones as necessary. Mothers will be given pedometers and shown how to keep a pedometer tracking chart. As with dietary choice, our objective is to have the mothers identify personal goals and strategies to achieve those goals, so they are more likely to continue to engage in physical activity after the intervention ends.', 'otherNumAtRisk': 94, 'deathsNumAtRisk': 94, 'otherNumAffected': 0, 'seriousNumAtRisk': 94, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Responsive Parenting', 'description': 'A responsive parenting intervention focusing on parenting, limit setting, and development strategies.\n\nResponsive Parenting: Behavior and Development Related to Diet and Physical Activity. The toddler parenting intervention will include modules on toddler behavior and development. We will devote sessions to topics involving parenting toddlers, limit setting, and child development.', 'otherNumAtRisk': 92, 'deathsNumAtRisk': 92, 'otherNumAffected': 0, 'seriousNumAtRisk': 92, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Child Safety', 'description': 'Attention control group. The parents received intervention to promote safety among toddlers.\n\nChild Safety: The intervention will focus on child safety issues, including car seat safety, fire safety, fall prevention, and poison prevention. Participants will set weekly child safety goals.', 'otherNumAtRisk': 91, 'deathsNumAtRisk': 91, 'otherNumAffected': 0, 'seriousNumAtRisk': 91, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change of Body Mass Index (BMI) Z-score for Toddlers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}, {'value': '91', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Maternal Lifestyle (Physical Activity and Nutrition)', 'description': 'A maternal lifestyle intervention focusing on healthy diet and physical activity patterns for mothers.\n\nMaternal Lifestyle (Physical Activity and Nutrition): At each session, mothers will identify a dietary goal for the next session (e.g., reduce soda intake). They will learn to track and evaluate their progress, setting new goals or modifying existing ones as necessary. Mothers will be given pedometers and shown how to keep a pedometer tracking chart. As with dietary choice, our objective is to have the mothers identify personal goals and strategies to achieve those goals, so they are more likely to continue to engage in physical activity after the intervention ends.'}, {'id': 'OG001', 'title': 'Responsive Parenting', 'description': 'A responsive parenting intervention focusing on parenting, limit setting, and development strategies.\n\nResponsive Parenting: Behavior and Development Related to Diet and Physical Activity. The toddler parenting intervention will include modules on toddler behavior and development. We will devote sessions to topics involving parenting toddlers, limit setting, and child development.'}, {'id': 'OG002', 'title': 'Child Safety', 'description': 'Attention control group. The parents received intervention to promote safety among toddlers.\n\nChild Safety: The intervention will focus on child safety issues, including car seat safety, fire safety, fall prevention, and poison prevention. Participants will set weekly child safety goals.'}], 'classes': [{'title': 'Toddlers BMI z-score at baseline', 'categories': [{'measurements': [{'value': '0.49', 'spread': '0.12', 'groupId': 'OG000'}, {'value': '0.50', 'spread': '0.12', 'groupId': 'OG001'}, {'value': '0.62', 'spread': '0.12', 'groupId': 'OG002'}]}]}, {'title': 'Toddler BMI z-score12-month follow-up', 'categories': [{'measurements': [{'value': '0.52', 'spread': '0.12', 'groupId': 'OG000'}, {'value': '0.61', 'spread': '0.12', 'groupId': 'OG001'}, {'value': '0.57', 'spread': '0.12', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.555', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.07', 'ciLowerLimit': '-0.17', 'ciUpperLimit': '0.31', 'pValueComment': 'The alpha for statistical significance is set at 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.12', 'estimateComment': 'This is to compare change in maternal lifestyle group to child safety group.', 'groupDescription': 'H0: There are no differences between the maternal lifestyle and child safety groups in the change in BMI z-score over time. Mixed models included the interaction between time and intervention, accounting for clustering of the repeated measures within each individual.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'If the 95% confidence interval of the difference in the change over time does not include 0, it means that there is a significant difference in the change over time between the two groups.'}, {'pValue': '0.200', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.16', 'ciLowerLimit': '-0.08', 'ciUpperLimit': '0.39', 'pValueComment': 'Two-side test', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.12', 'estimateComment': 'This is to compare the Responsive Parenting to the safety intervention group.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': '95% CI'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 12-month Follow-up', 'description': 'Measured weight and height for the toddlers, transferred to age and gender-specific body mass index (BMI) Z-score. The range of BMI z-score is usually between -5 and +5. BMI z-score lower than -1.645 is defined as underweight. The BMI z-score from -1.645 to 1.036 is normal weight and BMI z-score greater or equal to 1.645 is obese.', 'unitOfMeasure': 'z-score', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Toddlers in low-income families, defined as WIC-eligible (income \\< 185% of poverty index). WIC=Special Supplementary Program for Women, Infants, and Children.'}, {'type': 'PRIMARY', 'title': 'Change in Body Mass Index (BMI) Score Among Mothers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}, {'value': '91', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Maternal Lifestyle (Physical Activity and Nutrition)', 'description': 'A maternal lifestyle intervention focusing on healthy diet and physical activity patterns for mothers.\n\nMaternal Lifestyle (Physical Activity and Nutrition): At each session, mothers will identify a dietary goal for the next session (e.g., reduce soda intake). They will learn to track and evaluate their progress, setting new goals or modifying existing ones as necessary. Mothers will be given pedometers and shown how to keep a pedometer tracking chart. As with dietary choice, our objective is to have the mothers identify personal goals and strategies to achieve those goals, so they are more likely to continue to engage in physical activity after the intervention ends.'}, {'id': 'OG001', 'title': 'Responsive Parenting', 'description': 'A responsive parenting intervention focusing on parenting, limit setting, and development strategies.\n\nResponsive Parenting: Behavior and Development Related to Diet and Physical Activity. The toddler parenting intervention will include modules on toddler behavior and development. We will devote sessions to topics involving parenting toddlers, limit setting, and child development.'}, {'id': 'OG002', 'title': 'Child Safety', 'description': 'Attention control group. The parents received intervention to promote safety among toddlers.\n\nChild Safety: The intervention will focus on child safety issues, including car seat safety, fire safety, fall prevention, and poison prevention. Participants will set weekly child safety goals.'}], 'classes': [{'title': 'Maternal BMI at baseline', 'categories': [{'measurements': [{'value': '31.98', 'spread': '0.98', 'groupId': 'OG000'}, {'value': '31.90', 'spread': '0.99', 'groupId': 'OG001'}, {'value': '31.51', 'spread': '0.99', 'groupId': 'OG002'}]}]}, {'title': 'Maternal BMI at 12-month follow-up', 'categories': [{'measurements': [{'value': '32.22', 'spread': '0.99', 'groupId': 'OG000'}, {'value': '32.21', 'spread': '0.99', 'groupId': 'OG001'}, {'value': '31.85', 'spread': '1.00', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.739', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.11', 'ciLowerLimit': '-0.74', 'ciUpperLimit': '0.52', 'pValueComment': 'The alpha for statistical significance is set at 0.05', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.32', 'estimateComment': 'This is to compare maternal lifestyle to child safety group.', 'groupDescription': 'H0: There is no difference between maternal lifestyle and child safety groups in the change of BMI over time.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': '95% confidence interval (CI) was estimated. If the 95% CI does not include 0, it means there is significant difference in the change over time between the two groups.'}, {'pValue': '0.904', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.04', 'ciLowerLimit': '-0.66', 'ciUpperLimit': '0.59', 'pValueComment': 'The alpha for statistical significance was set at 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.32', 'estimateComment': 'This is to compare the responsive parenting group to the child safety group.', 'groupDescription': 'H0: There are no differences in the change over time between responsive parenting and child safety groups.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'The 95% CI was estimated. If it does not include 0, it means that there is a statistically significant difference in the change over time between the two groups.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 12 month Follow-up', 'description': 'Change body mass index (BMI, kg/m\\^2, calculated by measured weight and height) from baseline to 12-month follow-up. The BMI ranges usually ranges from 0-50 with higher score indicating higher weight regarding the height. Scores above 25 are considered overweight and scores above 30 are considered obese.', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Mothers of toddlers participating in study, low-income, defined as WIC-eligible.'}, {'type': 'SECONDARY', 'title': 'Change of Diet Quality for Toddlers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}, {'value': '91', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Maternal Lifestyle (Physical Activity and Nutrition)', 'description': 'A maternal lifestyle intervention focusing on healthy diet and physical activity patterns for mothers.\n\nMaternal Lifestyle (Physical Activity and Nutrition): At each session, mothers will identify a dietary goal for the next session (e.g., reduce soda intake). They will learn to track and evaluate their progress, setting new goals or modifying existing ones as necessary. Mothers will be given pedometers and shown how to keep a pedometer tracking chart. As with dietary choice, our objective is to have the mothers identify personal goals and strategies to achieve those goals, so they are more likely to continue to engage in physical activity after the intervention ends.'}, {'id': 'OG001', 'title': 'Responsive Parenting', 'description': 'A responsive parenting intervention focusing on parenting, limit setting, and development strategies.\n\nResponsive Parenting: Behavior and Development Related to Diet and Physical Activity. The toddler parenting intervention will include modules on toddler behavior and development. We will devote sessions to topics involving parenting toddlers, limit setting, and child development.'}, {'id': 'OG002', 'title': 'Child Safety', 'description': 'Attention control group. The parents received intervention to promote safety among toddlers.\n\nChild Safety: The intervention will focus on child safety issues, including car seat safety, fire safety, fall prevention, and poison prevention. Participants will set weekly child safety goals.'}], 'classes': [{'title': 'Toddler HEI total at baseline', 'categories': [{'measurements': [{'value': '52.44', 'spread': '1.18', 'groupId': 'OG000'}, {'value': '54.58', 'spread': '1.20', 'groupId': 'OG001'}, {'value': '55.1', 'spread': '1.19', 'groupId': 'OG002'}]}]}, {'title': 'Toddler HEI total at 12-month follow-up', 'categories': [{'measurements': [{'value': '52.84', 'spread': '1.38', 'groupId': 'OG000'}, {'value': '52.49', 'spread': '1.36', 'groupId': 'OG001'}, {'value': '52.19', 'spread': '1.35', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.168', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.31', 'ciLowerLimit': '-1.4', 'ciUpperLimit': '8.02', 'pValueComment': 'Alpha is set at 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.40', 'groupDescription': 'H0 is that there is no difference between maternal lifestyle and child safety groups in the change of HEI 2015 score over time.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'The 95% confidence interval (CI) for the difference in the change over time was estimated. If it does not include 0, it indicates significant difference in the change over time.'}, {'pValue': '0.733', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.82', 'ciLowerLimit': '-3.88', 'ciUpperLimit': '5.52', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.39', 'estimateComment': 'This is to compare the responsive feeding group to child safety group.', 'groupDescription': 'H0 is that there is no difference between the responsive parenting and child safety groups in the change of HEI score over time', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': '95% CI was estimated. If it does not include 0, it indicates that there is a significant difference in the change between the two groups.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 12-month Follow-up', 'description': 'Healthy Eating Index 2015 (HEI 2015) based on 24-hr diet recall. The range is 0-100, with higher scores representing better diet quality.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Change in HEI 2015 score for toddlers from baseline to 12 months'}, {'type': 'SECONDARY', 'title': 'Change of Diet Quality for Mothers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}, {'value': '91', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Maternal Lifestyle (Physical Activity and Nutrition)', 'description': 'A maternal lifestyle intervention focusing on healthy diet and physical activity patterns for mothers.\n\nMaternal Lifestyle (Physical Activity and Nutrition): At each session, mothers will identify a dietary goal for the next session (e.g., reduce soda intake). They will learn to track and evaluate their progress, setting new goals or modifying existing ones as necessary. Mothers will be given pedometers and shown how to keep a pedometer tracking chart. As with dietary choice, our objective is to have the mothers identify personal goals and strategies to achieve those goals, so they are more likely to continue to engage in physical activity after the intervention ends.'}, {'id': 'OG001', 'title': 'Responsive Parenting', 'description': 'A responsive parenting intervention focusing on parenting, limit setting, and development strategies.\n\nResponsive Parenting: Behavior and Development Related to Diet and Physical Activity. The toddler parenting intervention will include modules on toddler behavior and development. We will devote sessions to topics involving parenting toddlers, limit setting, and child development.'}, {'id': 'OG002', 'title': 'Child Safety', 'description': 'Attention control group. The parents received intervention to promote safety among toddlers.\n\nChild Safety: The intervention will focus on child safety issues, including car seat safety, fire safety, fall prevention, and poison prevention. Participants will set weekly child safety goals.'}], 'classes': [{'title': 'Baseline HEI 2015', 'categories': [{'measurements': [{'value': '46.88', 'spread': '1.32', 'groupId': 'OG000'}, {'value': '48.71', 'spread': '1.35', 'groupId': 'OG001'}, {'value': '48.52', 'spread': '1.34', 'groupId': 'OG002'}]}]}, {'title': '12-month HEI 2015', 'categories': [{'measurements': [{'value': '48.39', 'spread': '1.52', 'groupId': 'OG000'}, {'value': '46.90', 'spread': '1.53', 'groupId': 'OG001'}, {'value': '46.74', 'spread': '1.57', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.186', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.30', 'ciLowerLimit': '-1.6', 'ciUpperLimit': '8.2', 'pValueComment': 'Alpha is set at 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.49', 'estimateComment': 'This is to compare the maternal lifestyle group to the child safety group.', 'groupDescription': 'Null hypothesis is that there are no differences between the two groups regarding the change of HEI 2015 score over time.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'The 95% CI was estimated. If it does not include 0, it indicates that there is significant difference in the change over time between the two groups.'}, {'pValue': '0.990', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.03', 'ciLowerLimit': '-4.97', 'ciUpperLimit': '4.91', 'pValueComment': 'Alpha is set to 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.51', 'estimateComment': 'This is to compare the responsive parenting group to child safety group.', 'groupDescription': 'H0 is there is no difference in the change of maternal HEI score over time between the two groups.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': '95% CI for the difference in change over time was estimated. If it does not include 0, it indicates that there is significant difference between the two groups.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 12-month Follow-up', 'description': 'Healthy Eating Index (HEI 15) is calculated based on 24 hour diet recall. Scores range from 0-100, with higher scores optimal', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Mothers of toddlers'}, {'type': 'SECONDARY', 'title': 'Change of Child Physical Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}, {'value': '91', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Maternal Lifestyle (Physical Activity and Nutrition)', 'description': 'A maternal lifestyle intervention focusing on healthy diet and physical activity patterns for mothers.\n\nMaternal Lifestyle (Physical Activity and Nutrition): At each session, mothers will identify a dietary goal for the next session (e.g., reduce soda intake). They will learn to track and evaluate their progress, setting new goals or modifying existing ones as necessary. Mothers will be given pedometers and shown how to keep a pedometer tracking chart. As with dietary choice, our objective is to have the mothers identify personal goals and strategies to achieve those goals, so they are more likely to continue to engage in physical activity after the intervention ends.'}, {'id': 'OG001', 'title': 'Responsive Parenting', 'description': 'A responsive parenting intervention focusing on parenting, limit setting, and development strategies.\n\nResponsive Parenting: Behavior and Development Related to Diet and Physical Activity. The toddler parenting intervention will include modules on toddler behavior and development. We will devote sessions to topics involving parenting toddlers, limit setting, and child development.'}, {'id': 'OG002', 'title': 'Child Safety', 'description': 'Attention control group. The parents received intervention to promote safety among toddlers.\n\nChild Safety: The intervention will focus on child safety issues, including car seat safety, fire safety, fall prevention, and poison prevention. Participants will set weekly child safety goals.'}], 'classes': [{'title': 'Toddler MVPA at baseline', 'categories': [{'measurements': [{'value': '44.56', 'spread': '4.92', 'groupId': 'OG000'}, {'value': '52.39', 'spread': '4.98', 'groupId': 'OG001'}, {'value': '64.18', 'spread': '5.11', 'groupId': 'OG002'}]}]}, {'title': 'Toddler MVPA at 12-month follow', 'categories': [{'measurements': [{'value': '73.10', 'spread': '7.37', 'groupId': 'OG000'}, {'value': '71.05', 'spread': '7.13', 'groupId': 'OG001'}, {'value': '69.05', 'spread': '7.14', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.034', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '23.67', 'ciLowerLimit': '1.88', 'ciUpperLimit': '45.46', 'pValueComment': 'Alpha is set at 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '11.03', 'estimateComment': 'This is for maternal lifestyle group compared to safety control group.', 'groupDescription': 'Null hypothesis is there were no differences in the change over time for toddler MVPA across the two groups.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'A 95% CI was estimated. If it does not include 0, it indicates significant difference in change over time between the two groups.'}, {'pValue': '0.216', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13.52', 'ciLowerLimit': '-7.98', 'ciUpperLimit': '35.03', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '10.89', 'estimateComment': 'This is to compare the responsive parenting group to child safety group.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'H0 is that there is no difference between the change of MVPA over time between the two groups.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 12-month Follow-up', 'description': 'Physical activity is measured by wearing an accelerometer for 7 days. Using standards for toddlers, we count the number of minutes in moderate-vigorous physical activity (MVPA) per day, and averaged over the number of days measured, higher scores mean more physical activity.', 'unitOfMeasure': 'minutes per day', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Toddlers who participated in the trial, from low-income families, defined as WIC-eligible'}, {'type': 'SECONDARY', 'title': 'Change of Maternal Physical Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}, {'value': '91', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Maternal Lifestyle (Physical Activity and Nutrition)', 'description': 'A maternal lifestyle intervention focusing on healthy diet and physical activity patterns for mothers.\n\nMaternal Lifestyle (Physical Activity and Nutrition): At each session, mothers will identify a dietary goal for the next session (e.g., reduce soda intake). They will learn to track and evaluate their progress, setting new goals or modifying existing ones as necessary. Mothers will be given pedometers and shown how to keep a pedometer tracking chart. As with dietary choice, our objective is to have the mothers identify personal goals and strategies to achieve those goals, so they are more likely to continue to engage in physical activity after the intervention ends.'}, {'id': 'OG001', 'title': 'Responsive Parenting', 'description': 'A responsive parenting intervention focusing on parenting, limit setting, and development strategies.\n\nResponsive Parenting: Behavior and Development Related to Diet and Physical Activity. The toddler parenting intervention will include modules on toddler behavior and development. We will devote sessions to topics involving parenting toddlers, limit setting, and child development.'}, {'id': 'OG002', 'title': 'Child Safety', 'description': 'Attention control group. The parents received intervention to promote safety among toddlers.\n\nChild Safety: The intervention will focus on child safety issues, including car seat safety, fire safety, fall prevention, and poison prevention. Participants will set weekly child safety goals.'}], 'classes': [{'title': 'Maternal MVPA at baseline', 'categories': [{'measurements': [{'value': '23.10', 'spread': '2.06', 'groupId': 'OG000'}, {'value': '26.11', 'spread': '2.17', 'groupId': 'OG001'}, {'value': '27.76', 'spread': '2.17', 'groupId': 'OG002'}]}]}, {'title': 'Maternal MVPA at 12-month follow', 'categories': [{'measurements': [{'value': '27.41', 'spread': '3.07', 'groupId': 'OG000'}, {'value': '20.42', 'spread': '3.21', 'groupId': 'OG001'}, {'value': '21.09', 'spread': '3.22', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.024', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.97', 'ciLowerLimit': '1.46', 'ciUpperLimit': '20.48', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.82', 'estimateComment': 'This is to compare the maternal lifestyle group to the child safety group.', 'groupDescription': 'H0 is that there is no difference in the change of maternal MVPA over time between the two groups.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'The 95% CI for the difference in the change between the two groups was estimated. If it does not include 0, it indicates that there is a significant difference by group in the change.'}, {'pValue': '0.804', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.98', 'ciLowerLimit': '-8.76', 'ciUpperLimit': '10.72', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.94', 'estimateComment': 'This is to compare responsive parenting group to child safety group.', 'groupDescription': 'H0 is that there is no significant difference in the change of maternal MVPA between the two groups.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'The 95% CI was estimated. If it does not include 0, it indicates that there is a significant difference by group in the difference.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline-12 month follow up', 'description': 'Physical activity is measured by wearing an accelerometer for 7 days. Using standards for adults, we count the number of minutes in moderate-vigorous physical activity (MVPA) per day, and averaged over the number of days measured, higher scores mean more physical activity.', 'unitOfMeasure': 'minutes per day', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Change in the number of steps per day from baseline to 12-month follow-up in MVPA'}, {'type': 'SECONDARY', 'title': 'Feeding Style', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}, {'value': '91', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Maternal Lifestyle (Physical Activity and Nutrition)', 'description': 'A maternal lifestyle intervention focusing on healthy diet and physical activity patterns for mothers.\n\nMaternal Lifestyle (Physical Activity and Nutrition): At each session, mothers will identify a dietary goal for the next session (e.g., reduce soda intake). They will learn to track and evaluate their progress, setting new goals or modifying existing ones as necessary. Mothers will be given pedometers and shown how to keep a pedometer tracking chart. As with dietary choice, our objective is to have the mothers identify personal goals and strategies to achieve those goals, so they are more likely to continue to engage in physical activity after the intervention ends.'}, {'id': 'OG001', 'title': 'Responsive Parenting', 'description': 'A responsive parenting intervention focusing on parenting, limit setting, and development strategies.\n\nResponsive Parenting: Behavior and Development Related to Diet and Physical Activity. The toddler parenting intervention will include modules on toddler behavior and development. We will devote sessions to topics involving parenting toddlers, limit setting, and child development.'}, {'id': 'OG002', 'title': 'Child Safety', 'description': 'Attention control group. The parents received intervention to promote safety among toddlers.\n\nChild Safety: The intervention will focus on child safety issues, including car seat safety, fire safety, fall prevention, and poison prevention. Participants will set weekly child safety goals.'}], 'classes': [{'title': 'Maternal feeding style at baseline', 'categories': [{'measurements': [{'value': '4.69', 'spread': '0.11', 'groupId': 'OG000'}, {'value': '4.42', 'spread': '0.11', 'groupId': 'OG001'}, {'value': '4.71', 'spread': '0.12', 'groupId': 'OG002'}]}]}, {'title': 'Maternal feeding style at 12-month', 'categories': [{'measurements': [{'value': '5.07', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '5.19', 'spread': '0.14', 'groupId': 'OG001'}, {'value': '5.46', 'spread': '0.13', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.056', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.36', 'ciLowerLimit': '-0.78', 'ciUpperLimit': '0.06', 'pValueComment': 'Alpha is set at 0.05 for statistical significance.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.21', 'estimateComment': 'This is to compare maternal lifestyle group to the child safety group.', 'groupDescription': 'The 95% CI was estimated. If it does not include 0, it indicates that there is a significant difference by group in the difference.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'The 95% CI was estimated. If it does not include 0, it indicates that there is a significant difference by group in the difference.'}, {'pValue': '0.896', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.03', 'ciLowerLimit': '-0.39', 'ciUpperLimit': '0.45', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.21', 'estimateComment': 'This is to compare responsive parenting group to child safety group.', 'groupDescription': 'The 95% CI was estimated. If it does not include 0, it indicates that there is a significant difference by group in the difference.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Alpha is set at 0.05 to indicate statistical significance.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 12 month Follow-up', 'description': 'The Emotional Availability Scales (EAS) include 4 maternal scales (sensitivity, structuring, non-intrusiveness, and non-hostile) and 2 child scales (responsiveness and involvement), each rated on 7-point Likert scales, with high scores optimal. The maternal and child sub-scale scores were averaged for a total mealtime interaction score. The total score ranges from 1-7. Coders were trained until they demonstrated inter-rater reliability \\>0.80 based on intraclass correlation coefficients with 10 observations from the scale creator and 10 observations with the faculty coordinator. Inter-rater reliability was reviewed through weekly reliability checks.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Change in Emotional Availability Scale scores from baseline to 12-month follow-up'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Maternal Lifestyle (Physical Activity and Nutrition)', 'description': 'A maternal lifestyle intervention focusing on healthy diet and physical activity patterns for mothers.\n\nMaternal Lifestyle (Physical Activity and Nutrition): At each session, mothers will identify a dietary goal for the next session (e.g., reduce soda intake). They will learn to track and evaluate their progress, setting new goals or modifying existing ones as necessary. Mothers will be given pedometers and shown how to keep a pedometer tracking chart. As with dietary choice, our objective is to have the mothers identify personal goals and strategies to achieve those goals, so they are more likely to continue to engage in physical activity after the intervention ends.'}, {'id': 'FG001', 'title': 'Responsive Parenting', 'description': 'A responsive parenting intervention focusing on parenting, limit setting, and development strategies.\n\nResponsive Parenting: Behavior and Development Related to Diet and Physical Activity. The toddler parenting intervention will include modules on toddler behavior and development. We will devote sessions to topics involving parenting toddlers, limit setting, and child development.'}, {'id': 'FG002', 'title': 'Child Safety', 'description': 'Attention control group. The parents received intervention to promote safety among toddlers.\n\nChild Safety: The intervention will focus on child safety issues, including car seat safety, fire safety, fall prevention, and poison prevention. Participants will set weekly child safety goals.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '94'}, {'groupId': 'FG001', 'numSubjects': '92'}, {'groupId': 'FG002', 'numSubjects': '91'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '73'}, {'groupId': 'FG001', 'numSubjects': '76'}, {'groupId': 'FG002', 'numSubjects': '75'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '16'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'BG000'}, {'value': '92', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}, {'value': '277', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Maternal Lifestyle (Physical Activity and Nutrition)', 'description': 'A maternal lifestyle intervention focusing on healthy diet and physical activity patterns for mothers.\n\nMaternal Lifestyle (Physical Activity and Nutrition): At each session, mothers will identify a dietary goal for the next session (e.g., reduce soda intake). They will learn to track and evaluate their progress, setting new goals or modifying existing ones as necessary. Mothers will be given pedometers and shown how to keep a pedometer tracking chart. As with dietary choice, our objective is to have the mothers identify personal goals and strategies to achieve those goals, so they are more likely to continue to engage in physical activity after the intervention ends.'}, {'id': 'BG001', 'title': 'Responsive Parenting', 'description': 'A responsive parenting intervention focusing on parenting, limit setting, and development strategies.\n\nResponsive Parenting: Behavior and Development Related to Diet and Physical Activity. The toddler parenting intervention will include modules on toddler behavior and development. We will devote sessions to topics involving parenting toddlers, limit setting, and child development.'}, {'id': 'BG002', 'title': 'Child Safety', 'description': 'Attention control group. The parents received intervention to promote safety among toddlers.\n\nChild Safety: The intervention will focus on child safety issues, including car seat safety, fire safety, fall prevention, and poison prevention. Participants will set weekly child safety goals.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '26.17', 'spread': '5.9', 'groupId': 'BG000'}, {'value': '27.53', 'spread': '6.5', 'groupId': 'BG001'}, {'value': '28.16', 'spread': '5.99', 'groupId': 'BG002'}, {'value': '27.28', 'spread': '6.17', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '94', 'groupId': 'BG000'}, {'value': '92', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}, {'value': '277', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '92', 'groupId': 'BG000'}, {'value': '92', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}, {'value': '272', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}, {'value': '193', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '62', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '94', 'groupId': 'BG000'}, {'value': '92', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}, {'value': '277', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Maternal age', 'classes': [{'categories': [{'measurements': [{'value': '26.17', 'spread': '5.9', 'groupId': 'BG000'}, {'value': '27.53', 'spread': '6.5', 'groupId': 'BG001'}, {'value': '28.16', 'spread': '5.99', 'groupId': 'BG002'}, {'value': '27.28', 'spread': '6.17', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Household Poverty Ratio', 'classes': [{'categories': [{'measurements': [{'value': '68', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}, {'value': '185', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Household poverty ratio was calculated based on the federal poverty threshold for the year the data were collected using mother-reported total family income and number of household members. We summed the number of families with poverty ratio below 1, indicating that the average income for the family size is below the official definition of poverty.', 'unitOfMeasure': 'Participants'}, {'title': 'Maternal Education', 'classes': [{'categories': [{'measurements': [{'value': '74', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}, {'value': '224', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'We calculated the number of mothers who had completed high school or the General Educational Development (GED) test.', 'unitOfMeasure': 'Participants'}, {'title': 'Maternal Marital Status', 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '78', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Count of the number of mothers who were married', 'unitOfMeasure': 'Participants'}, {'title': 'Location (Urban/Semi-Urban)', 'classes': [{'categories': [{'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}, {'value': '167', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Families were recruited from 2 sites: urban and semi-urban. We counted the number of mothers from the urban site', 'unitOfMeasure': 'Participants'}, {'title': 'Maternal BMI', 'classes': [{'categories': [{'measurements': [{'value': '31.98', 'spread': '9.48', 'groupId': 'BG000'}, {'value': '31.90', 'spread': '9.78', 'groupId': 'BG001'}, {'value': '31.51', 'spread': '9.24', 'groupId': 'BG002'}, {'value': '31.80', 'spread': '9.47', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Weight and height are measured to calculate BMI (kg/m\\^2).', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Maternal dietary intake', 'classes': [{'categories': [{'measurements': [{'value': '2281', 'spread': '745', 'groupId': 'BG000'}, {'value': '2214', 'spread': '1053', 'groupId': 'BG001'}, {'value': '2033', 'spread': '738', 'groupId': 'BG002'}, {'value': '2177', 'spread': '859', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kcal/day', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Maternal physical activity', 'classes': [{'categories': [{'measurements': [{'value': '23.22', 'spread': '18.07', 'groupId': 'BG000'}, {'value': '26.14', 'spread': '20.36', 'groupId': 'BG001'}, {'value': '27.52', 'spread': '17.82', 'groupId': 'BG002'}, {'value': '25.54', 'spread': '18.76', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Minutes Mod/Vig Activity/Day', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Toddler age', 'classes': [{'categories': [{'measurements': [{'value': '19.98', 'spread': '5.55', 'groupId': 'BG000'}, {'value': '20.22', 'spread': '5.56', 'groupId': 'BG001'}, {'value': '20.14', 'spread': '5.46', 'groupId': 'BG002'}, {'value': '20.11', 'spread': '5.50', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Toddler sex', 'classes': [{'categories': [{'title': 'Females', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}, {'value': '130', 'groupId': 'BG003'}]}, {'title': 'Males', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}, {'value': '147', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Toddler race/ethnicity', 'classes': [{'categories': [{'title': 'Non-Hispanic African American', 'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}, {'value': '193', 'groupId': 'BG003'}]}, {'title': 'Non-Hispanic White', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '62', 'groupId': 'BG003'}]}, {'title': 'Hispanic', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}, {'title': 'Mixed', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Toddler Body Mass Index (BMI) Z-score', 'classes': [{'categories': [{'measurements': [{'value': '0.49', 'spread': '1.10', 'groupId': 'BG000'}, {'value': '0.51', 'spread': '1.16', 'groupId': 'BG001'}, {'value': '0.63', 'spread': '1.14', 'groupId': 'BG002'}, {'value': '0.54', 'spread': '1.13', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Body Mass Index, kg/m\\^2, is calculated by measured weight and height. BMI z-scores are measures of relative weight adjusted for child age and sex. The Z-score indicates the number of standard deviations away from a reference population in the same age range and with the same sex. These scores are used to determine weight status (e.g., overweight, obese, etc.)', 'unitOfMeasure': 'Body mass index z-scores', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Toddler dietary intake', 'classes': [{'categories': [{'measurements': [{'value': '1282', 'spread': '476', 'groupId': 'BG000'}, {'value': '1297', 'spread': '463', 'groupId': 'BG001'}, {'value': '1262', 'spread': '419', 'groupId': 'BG002'}, {'value': '1281', 'spread': '453', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Total energy kcal/day', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Toddler physical activity', 'classes': [{'categories': [{'measurements': [{'value': '45.45', 'spread': '38.53', 'groupId': 'BG000'}, {'value': '52.99', 'spread': '35.87', 'groupId': 'BG001'}, {'value': '64.62', 'spread': '45.16', 'groupId': 'BG002'}, {'value': '54.08', 'spread': '40.43', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Minutes Mod/Vig physical activity/day', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 277}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-04', 'studyFirstSubmitDate': '2013-02-11', 'resultsFirstSubmitDate': '2019-07-23', 'studyFirstSubmitQcDate': '2015-11-23', 'lastUpdatePostDateStruct': {'date': '2020-05-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-05-04', 'studyFirstPostDateStruct': {'date': '2015-11-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-05-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of Body Mass Index (BMI) Z-score for Toddlers', 'timeFrame': 'Baseline to 12-month Follow-up', 'description': 'Measured weight and height for the toddlers, transferred to age and gender-specific body mass index (BMI) Z-score. The range of BMI z-score is usually between -5 and +5. BMI z-score lower than -1.645 is defined as underweight. The BMI z-score from -1.645 to 1.036 is normal weight and BMI z-score greater or equal to 1.645 is obese.'}, {'measure': 'Change in Body Mass Index (BMI) Score Among Mothers', 'timeFrame': 'Baseline to 12 month Follow-up', 'description': 'Change body mass index (BMI, kg/m\\^2, calculated by measured weight and height) from baseline to 12-month follow-up. The BMI ranges usually ranges from 0-50 with higher score indicating higher weight regarding the height. Scores above 25 are considered overweight and scores above 30 are considered obese.'}], 'secondaryOutcomes': [{'measure': 'Change of Diet Quality for Toddlers', 'timeFrame': 'Baseline to 12-month Follow-up', 'description': 'Healthy Eating Index 2015 (HEI 2015) based on 24-hr diet recall. The range is 0-100, with higher scores representing better diet quality.'}, {'measure': 'Change of Diet Quality for Mothers', 'timeFrame': 'Baseline to 12-month Follow-up', 'description': 'Healthy Eating Index (HEI 15) is calculated based on 24 hour diet recall. Scores range from 0-100, with higher scores optimal'}, {'measure': 'Change of Child Physical Activity', 'timeFrame': 'Baseline to 12-month Follow-up', 'description': 'Physical activity is measured by wearing an accelerometer for 7 days. Using standards for toddlers, we count the number of minutes in moderate-vigorous physical activity (MVPA) per day, and averaged over the number of days measured, higher scores mean more physical activity.'}, {'measure': 'Change of Maternal Physical Activity', 'timeFrame': 'Baseline-12 month follow up', 'description': 'Physical activity is measured by wearing an accelerometer for 7 days. Using standards for adults, we count the number of minutes in moderate-vigorous physical activity (MVPA) per day, and averaged over the number of days measured, higher scores mean more physical activity.'}, {'measure': 'Feeding Style', 'timeFrame': 'Baseline to 12 month Follow-up', 'description': 'The Emotional Availability Scales (EAS) include 4 maternal scales (sensitivity, structuring, non-intrusiveness, and non-hostile) and 2 child scales (responsiveness and involvement), each rated on 7-point Likert scales, with high scores optimal. The maternal and child sub-scale scores were averaged for a total mealtime interaction score. The total score ranges from 1-7. Coders were trained until they demonstrated inter-rater reliability \\>0.80 based on intraclass correlation coefficients with 10 observations from the scale creator and 10 observations with the faculty coordinator. Inter-rater reliability was reviewed through weekly reliability checks.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Feeding practices', 'Diet', 'Physical activity', 'Prevention'], 'conditions': ['Overweight', 'Obesity', 'Depression']}, 'referencesModule': {'references': [{'pmid': '16595758', 'type': 'BACKGROUND', 'citation': 'Ogden CL, Carroll MD, Curtin LR, McDowell MA, Tabak CJ, Flegal KM. Prevalence of overweight and obesity in the United States, 1999-2004. JAMA. 2006 Apr 5;295(13):1549-55. doi: 10.1001/jama.295.13.1549.'}, {'pmid': '33752659', 'type': 'DERIVED', 'citation': 'Campbell KL, Wang Y, Kuhn AP, Black MM, Hager ER. An ecological momentary assessment study of physical activity behaviors among mothers of toddlers from low-income households. BMC Womens Health. 2021 Mar 22;21(1):120. doi: 10.1186/s12905-021-01243-2.'}, {'pmid': '33196078', 'type': 'DERIVED', 'citation': 'Covington L, Armstrong B, Trude ACB, Black MM. Longitudinal Associations Among Diet Quality, Physical Activity and Sleep Onset Consistency With Body Mass Index z-Score Among Toddlers in Low-income Families. Ann Behav Med. 2021 Jun 28;55(7):653-664. doi: 10.1093/abm/kaaa100.'}, {'pmid': '32885909', 'type': 'DERIVED', 'citation': 'Black MM, Hager ER, Wang Y, Hurley KM, Latta LW, Candelaria M, Caulfield LE. Toddler obesity prevention: A two-generation randomized attention-controlled trial. Matern Child Nutr. 2021 Jan;17(1):e13075. doi: 10.1111/mcn.13075. Epub 2020 Sep 4.'}, {'pmid': '31171491', 'type': 'DERIVED', 'citation': 'Armstrong B, Covington LB, Hager ER, Black MM. Objective sleep and physical activity using 24-hour ankle-worn accelerometry among toddlers from low-income families. Sleep Health. 2019 Oct;5(5):459-465. doi: 10.1016/j.sleh.2019.04.005. Epub 2019 Jun 3.'}, {'pmid': '28385953', 'type': 'DERIVED', 'citation': 'Wang Y, Gielen AC, Magder LS, Hager ER, Black MM. A randomised safety promotion intervention trial among low-income families with toddlers. Inj Prev. 2018 Feb;24(1):41-47. doi: 10.1136/injuryprev-2016-042178. Epub 2017 Apr 6.'}], 'seeAlsoLinks': [{'url': 'https://www.medschool.umaryland.edu/growth/', 'label': 'Study Website'}]}, 'descriptionModule': {'briefSummary': 'The hypothesis is that toddlers with parents who are randomized to a parenting intervention and toddlers with parents who are randomized to the maternal intervention focused on maternal diet and physical activity will be more likely to have weight status within normal and to consume a healthy diet and engage in physical activity than toddlers with parents in a placebo (safety) intervention.', 'detailedDescription': 'Background:\n\nOverweight is a serious public health problem which can begin in early childhood. Factors which contribute to overweight include: overfeeding, excessive intakes of fat and sugar; frequent sedentary activities (i.e. television watching).\n\nOverweight, defined as a BMI \\> 95th percentile, in early childhood has reached epidemic proportions with 14% of 2-5 year olds overweight and 26.2% "at risk of overweight," defined as a BMI \\> 85th percentile (Ogden et al., 2006).\n\nDietary and physical activity patterns established early in life track over time, making the first few years of life an ideal time to help families establish healthy eating and physical activity behaviors and avoid overweight. This project works to identify techniques that could prevent overweight.\n\nPurpose of Study:\n\nThe investigators are collaborating with the Anne Arundel County, MD Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) and the University of Maryland\'s Pediatric Ambulatory Center to implement strategies that will prevent overweight among toddlers. The project focuses on the dietary, physical activity, and growth patterns of WIC toddlers. The investigators are conducting a 3-cell randomized trial consisting of: 1) a maternal intervention focusing on healthy diet and physical activity patterns for mothers; 2) a toddler parenting intervention focusing on parenting, limit setting, and development strategies; and 3) an intervention on child safety. The interventions are implemented over 3 months, with 8 sessions.\n\nThe investigators hypothesize that altering maternal behavior will have a positive impact on the growth and development of the toddler by preventing behaviors that lead to overweight among children. The parenting intervention will improve parenting skills by offering information on proper approaches to feeding, discipline and educational play. The investigators will compare the growth patterns of toddlers whose mothers were randomized to the maternal and parenting interventions with those in the safety intervention. This study design allows us to examine the mechanisms linking the interventions to improvements in diet, physical activity, and growth.\n\nIn addition, the investigators will conduct the safety promotion intervention for the attention control group, considering the high risk of unintentional injuries among the toddlers from low-income families. The investigators also hypothesize that the safety promotion intervention will reduce the safety problems of the toddlers\' homes. The underlying mechanisms will be examined, if there is a significant intervention effect.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least 18 yrs old\n* Has child between 12-32 months\n* Child able to walk\n* Birth weight of child at least 5lbs. 8oz.\n\nExclusion Criteria:\n\n* Mom cannot be pregnant\n* No known congenital problems or disabilities'}, 'identificationModule': {'nctId': 'NCT02615158', 'acronym': 'TOPS', 'briefTitle': 'Toddler Overweight Prevention Study Among Low-Income Families', 'organization': {'class': 'OTHER', 'fullName': 'University of Maryland, Baltimore'}, 'officialTitle': 'Toddler Overweight Prevention: Comparison of Maternal and Toddler Intervention', 'orgStudyIdInfo': {'id': 'H-27980'}, 'secondaryIdInfos': [{'id': 'R01HD056099', 'link': 'https://reporter.nih.gov/quickSearch/R01HD056099', 'type': 'NIH'}, {'id': 'R03HD077156', 'link': 'https://reporter.nih.gov/quickSearch/R03HD077156', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Maternal Physical Activity and Nutrition', 'description': 'A maternal intervention focusing on healthy diet and physical activity patterns for mothers.', 'interventionNames': ['Behavioral: Maternal Physical Activity and Nutrition']}, {'type': 'EXPERIMENTAL', 'label': 'Parenting', 'description': 'A toddler parenting intervention focusing on parenting, limit setting, and development strategies.', 'interventionNames': ['Behavioral: Parenting']}, {'type': 'EXPERIMENTAL', 'label': 'Child Safety', 'description': 'Attention control group. The parents received intervention to promote safety among toddlers.', 'interventionNames': ['Behavioral: Child Safety']}], 'interventions': [{'name': 'Maternal Physical Activity and Nutrition', 'type': 'BEHAVIORAL', 'description': 'At each session, mothers will identify a dietary goal for the next session (e.g., reduce soda intake). They will learn to track and evaluate their progress, setting new goals or modifying existing ones as necessary. Mothers will be given pedometers and shown how to keep a pedometer tracking chart. As with dietary choice, our objective is to have the mothers identify personal goals and strategies to achieve those goals, so they are more likely to continue to engage in physical activity after the intervention ends.', 'armGroupLabels': ['Maternal Physical Activity and Nutrition']}, {'name': 'Parenting', 'type': 'BEHAVIORAL', 'description': 'Behavior and Development Related to Diet and Physical Activity. The toddler parenting intervention will include modules on toddler behavior and development. We will devote sessions to topics involving parenting toddlers, limit setting, and child development.', 'armGroupLabels': ['Parenting']}, {'name': 'Child Safety', 'type': 'BEHAVIORAL', 'description': 'The intervention will focus on child safety issues, including car seat safety, fire safety, fall prevention, and poison prevention. Participants will set weekly child safety goals.', 'armGroupLabels': ['Child Safety']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'University of Maryland, School of Medicine', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'University of Maryland', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Maureen M Black, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Maryland, College Park'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Maryland, Baltimore', 'class': 'OTHER'}, 'collaborators': [{'name': 'Johns Hopkins University', 'class': 'OTHER'}, {'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Maureen Black', 'investigatorAffiliation': 'University of Maryland, Baltimore'}}}}