Ignite Creation Date:
2025-12-24 @ 1:05 PM
Ignite Modification Date:
2026-01-19 @ 10:39 AM
Study NCT ID:
NCT03880461
Status:
COMPLETED
Last Update Posted:
2025-04-18
First Post:
2019-03-13
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Mobile Health Intervention to Achieve Appropriate Gestational Weight Gain in Overweight/Obese Women
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000078064', 'term': 'Gestational Weight Gain'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D001836', 'term': 'Body Weight Changes'}], 'ancestors': [{'id': 'D015430', 'term': 'Weight Gain'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'monique.m.hedderson@kp.org', 'phone': '925-520-0785', 'title': 'Monique Hedderson, Ph.D.', 'organization': 'Kaiser Permanente Northern California'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse outcome data were collected during pregnancy from enrollment to delivery (duration of up to 9 months).', 'eventGroups': [{'id': 'EG000', 'title': 'Intervention Arm - PATIENTS', 'description': 'In addition to usual medical care, patients in the intervention arm will receive access to mHealth tools to manage gestational weight gain (GWG), including a scale, physical activity tracker, and smartphone application, and for those not meeting GWG guidelines, personalized text messages and personalized 1-1 coaching sessions.', 'otherNumAtRisk': 714, 'deathsNumAtRisk': 714, 'otherNumAffected': 44, 'seriousNumAtRisk': 714, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Usual Care Arm - PATIENTS', 'description': 'Patients in the usual care arm will receive the standard obstetric care offered at Kaiser Permanente Northern California.', 'otherNumAtRisk': 621, 'deathsNumAtRisk': 621, 'otherNumAffected': 29, 'seriousNumAtRisk': 621, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Total pregnancy loss or stillbirth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 714, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 621, 'numAffected': 29}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Total Gestational Weight Gain (GWG)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '591', 'groupId': 'OG000'}, {'value': '520', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Arm - PATIENTS', 'description': 'In addition to usual medical care, patients in the intervention arm will receive access to mHealth tools to manage gestational weight gain (GWG), including a scale, physical activity tracker, and smartphone application, and for those not meeting GWG guidelines, personalized text messages and personalized 1-1 coaching sessions.'}, {'id': 'OG001', 'title': 'Usual Care Arm - PATIENTS', 'description': 'Patients in the usual care arm will receive the standard obstetric care offered at Kaiser Permanente Northern California.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.5', 'spread': '5.7', 'groupId': 'OG000'}, {'value': '11.3', 'spread': '5.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.014', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'From 10 gestational weeks until time of delivery (duration of up to 9 months)', 'description': 'Calculated as last measured pregnancy weight at the time of delivery minus measured weight at 10 gestational weeks', 'unitOfMeasure': 'kilograms', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Rate of Total GWG', 'denoms': [{'units': 'Participants', 'counts': [{'value': '645', 'groupId': 'OG000'}, {'value': '560', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Arm - PATIENTS', 'description': 'In addition to usual medical care, patients in the intervention arm will receive access to mHealth tools to manage gestational weight gain (GWG), including a scale, physical activity tracker, and smartphone application, and for those not meeting GWG guidelines, personalized text messages and personalized 1-1 coaching sessions.'}, {'id': 'OG001', 'title': 'Usual Care Arm - PATIENTS', 'description': 'Patients in the usual care arm will receive the standard obstetric care offered at Kaiser Permanente Northern California.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.26', 'spread': '0.17', 'groupId': 'OG000'}, {'value': '0.28', 'spread': '0.16', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.003', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'From 10 gestational weeks until time of delivery (duration of up to 9 months)', 'description': 'Calculated as total gestational weight gain / (# of weeks between 10 gestational weeks and the time of delivery)', 'unitOfMeasure': 'kilograms/week', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': "Proportion of Women Meeting the Institute of Medicine's GWG Recommendation", 'denoms': [{'units': 'Participants', 'counts': [{'value': '645', 'groupId': 'OG000'}, {'value': '560', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Arm - PATIENTS', 'description': 'In addition to usual medical care, patients in the intervention arm will receive access to mHealth tools to manage gestational weight gain (GWG), including a scale, physical activity tracker, and smartphone application, and for those not meeting GWG guidelines, personalized text messages and personalized 1-1 coaching sessions.'}, {'id': 'OG001', 'title': 'Usual Care Arm - PATIENTS', 'description': 'Patients in the usual care arm will receive the standard obstetric care offered at Kaiser Permanente Northern California.'}], 'classes': [{'categories': [{'measurements': [{'value': '172', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.108', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From 10 gestational weeks until time of delivery (duration of up to 9 months)', 'description': "Proportion of women meeting the IOM's GWG recommendation for weekly rate of GWG", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Trimester-specific Weekly Rate of GWG', 'timeFrame': '0 - 13 gestational weeks; 14 - 26 gestational weeks; 27 - 40 gestational weeks', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'GWG Trajectory Throughout Pregnancy', 'timeFrame': 'From 10 gestational weeks until time of delivery (duration of up to 9 months)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Change in Moderate to Vigorous Physical Activity (in MET Hrs/Week) as Assessed by the Pregnancy Physical Activity Questionnaire (PPAQ)', 'timeFrame': 'Between 12 weeks and 33 weeks of pregnancy', 'description': 'We will assess change in moderate to vigorous physical activity between study assessments in pregnancy. The sports and exercise domain encompasses 10 PPAQ activities of moderate intensity (ranging 3.2 MET to 6 MET) and 2 PPAQ activities of vigorous intensity (6.5 MET and 7 MET). The volumes of all activities in the sports and exercise domain will be summed to arrive at an estimate of overall volume of moderate to vigorous intensity sports and exercise activity, expressed in MET hours per week. Higher levels of activity are generally associated with better outcomes. The distributions of all physical activity variables will be assessed for outliers.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Overall Diet Quality According to the Healthy Eating Index-2015 (HEI-2015)', 'timeFrame': 'Assessed at 12 weeks of pregnancy', 'description': 'The HEI-2015 reflects adherence to the 2015-2020 Dietary Guidelines for Americans; it is comprised of 13 components as well as an overall score. The scoring system ranges from 0 to 100, where higher values indicate a better diet quality.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Postpartum Weight Retention', 'timeFrame': 'Assessed at 6 weeks postpartum', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'The Proportion of Infants With Appropriate Birthweight (>10th and <90th Percentile of Sex-, Gestational Age-, and Racial/Ethnic-specific Distribution)', 'timeFrame': 'Assessed at birth', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Infant Growth (BMI Z-score)', 'timeFrame': 'From birth to 12 months of age', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intervention Arm - PATIENTS', 'description': 'In addition to usual medical care, patients in the intervention arm will receive access to mHealth tools to manage gestational weight gain (GWG), including a scale, physical activity tracker, and smartphone application, and for those not meeting GWG guidelines, personalized text messages and personalized 1-1 coaching sessions.'}, {'id': 'FG001', 'title': 'Usual Care Arm - PATIENTS', 'description': 'Patients in the usual care arm will receive the standard obstetric care offered at Kaiser Permanente Northern California.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '714'}, {'groupId': 'FG001', 'numSubjects': '621'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '645'}, {'groupId': 'FG001', 'numSubjects': '560'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '69'}, {'groupId': 'FG001', 'numSubjects': '61'}]}], 'dropWithdraws': [{'type': 'Determined ineligible after enrollment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '45'}, {'groupId': 'FG001', 'numSubjects': '44'}]}, {'type': 'No weight measurement after enrollment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '17'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '714', 'groupId': 'BG000'}, {'value': '621', 'groupId': 'BG001'}, {'value': '1335', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Intervention Arm - PATIENTS', 'description': 'In addition to usual medical care, patients in the intervention arm will receive access to mHealth tools to manage gestational weight gain (GWG), including a scale, physical activity tracker, and smartphone application, and for those not meeting GWG guidelines, personalized text messages and personalized 1-1 coaching sessions.'}, {'id': 'BG001', 'title': 'Usual Care Arm - PATIENTS', 'description': 'Patients in the usual care arm will receive the standard obstetric care offered at Kaiser Permanente Northern California.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '33.3', 'spread': '4.7', 'groupId': 'BG000'}, {'value': '33.4', 'spread': '4.5', 'groupId': 'BG001'}, {'value': '33.4', 'spread': '4.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': 'Age (years)', 'categories': [{'title': '21 - 29', 'measurements': [{'value': '158', 'groupId': 'BG000'}, {'value': '122', 'groupId': 'BG001'}, {'value': '280', 'groupId': 'BG002'}]}, {'title': '30 - 34', 'measurements': [{'value': '259', 'groupId': 'BG000'}, {'value': '238', 'groupId': 'BG001'}, {'value': '497', 'groupId': 'BG002'}]}, {'title': '35 - 39', 'measurements': [{'value': '234', 'groupId': 'BG000'}, {'value': '215', 'groupId': 'BG001'}, {'value': '449', 'groupId': 'BG002'}]}, {'title': '40 - 46', 'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '714', 'groupId': 'BG000'}, {'value': '621', 'groupId': 'BG001'}, {'value': '1335', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race / Ethnicity', 'categories': [{'title': 'Non-Hispanic White', 'measurements': [{'value': '237', 'groupId': 'BG000'}, {'value': '211', 'groupId': 'BG001'}, {'value': '448', 'groupId': 'BG002'}]}, {'title': 'Black', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}]}, {'title': 'Asian / Pacific Islander', 'measurements': [{'value': '175', 'groupId': 'BG000'}, {'value': '137', 'groupId': 'BG001'}, {'value': '312', 'groupId': 'BG002'}]}, {'title': 'Hispanic', 'measurements': [{'value': '186', 'groupId': 'BG000'}, {'value': '165', 'groupId': 'BG001'}, {'value': '351', 'groupId': 'BG002'}]}, {'title': 'Native American', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Islander', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Multiracial', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}]}, {'title': 'Unknown / Missing', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '714', 'groupId': 'BG000'}, {'value': '621', 'groupId': 'BG001'}, {'value': '1335', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Pre-pregnancy BMI (Continuous)', 'classes': [{'categories': [{'measurements': [{'value': '29.7', 'spread': '3.8', 'groupId': 'BG000'}, {'value': '30.0', 'spread': '3.9', 'groupId': 'BG001'}, {'value': '29.8', 'spread': '3.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Pre-pregnancy BMI (Customized)', 'classes': [{'categories': [{'title': 'Overweight (25.0 - 29.9)', 'measurements': [{'value': '430', 'groupId': 'BG000'}, {'value': '354', 'groupId': 'BG001'}, {'value': '784', 'groupId': 'BG002'}]}, {'title': 'Obese (30.0 - 39.9)', 'measurements': [{'value': '284', 'groupId': 'BG000'}, {'value': '267', 'groupId': 'BG001'}, {'value': '551', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Parity (Customized)', 'classes': [{'categories': [{'title': 'Nulliparous', 'measurements': [{'value': '319', 'groupId': 'BG000'}, {'value': '238', 'groupId': 'BG001'}, {'value': '557', 'groupId': 'BG002'}]}, {'title': 'Primiparous', 'measurements': [{'value': '270', 'groupId': 'BG000'}, {'value': '239', 'groupId': 'BG001'}, {'value': '509', 'groupId': 'BG002'}]}, {'title': 'Multiparous', 'measurements': [{'value': '103', 'groupId': 'BG000'}, {'value': '127', 'groupId': 'BG001'}, {'value': '230', 'groupId': 'BG002'}]}, {'title': 'Unknown / Missing', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-03-26', 'size': 133791, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-03-26T14:01', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1335}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-16', 'studyFirstSubmitDate': '2019-03-13', 'resultsFirstSubmitDate': '2025-03-27', 'studyFirstSubmitQcDate': '2019-03-15', 'lastUpdatePostDateStruct': {'date': '2025-04-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-04-16', 'studyFirstPostDateStruct': {'date': '2019-03-19', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total Gestational Weight Gain (GWG)', 'timeFrame': 'From 10 gestational weeks until time of delivery (duration of up to 9 months)', 'description': 'Calculated as last measured pregnancy weight at the time of delivery minus measured weight at 10 gestational weeks'}, {'measure': 'Rate of Total GWG', 'timeFrame': 'From 10 gestational weeks until time of delivery (duration of up to 9 months)', 'description': 'Calculated as total gestational weight gain / (# of weeks between 10 gestational weeks and the time of delivery)'}, {'measure': "Proportion of Women Meeting the Institute of Medicine's GWG Recommendation", 'timeFrame': 'From 10 gestational weeks until time of delivery (duration of up to 9 months)', 'description': "Proportion of women meeting the IOM's GWG recommendation for weekly rate of GWG"}], 'secondaryOutcomes': [{'measure': 'Trimester-specific Weekly Rate of GWG', 'timeFrame': '0 - 13 gestational weeks; 14 - 26 gestational weeks; 27 - 40 gestational weeks'}, {'measure': 'GWG Trajectory Throughout Pregnancy', 'timeFrame': 'From 10 gestational weeks until time of delivery (duration of up to 9 months)'}, {'measure': 'Change in Moderate to Vigorous Physical Activity (in MET Hrs/Week) as Assessed by the Pregnancy Physical Activity Questionnaire (PPAQ)', 'timeFrame': 'Between 12 weeks and 33 weeks of pregnancy', 'description': 'We will assess change in moderate to vigorous physical activity between study assessments in pregnancy. The sports and exercise domain encompasses 10 PPAQ activities of moderate intensity (ranging 3.2 MET to 6 MET) and 2 PPAQ activities of vigorous intensity (6.5 MET and 7 MET). The volumes of all activities in the sports and exercise domain will be summed to arrive at an estimate of overall volume of moderate to vigorous intensity sports and exercise activity, expressed in MET hours per week. Higher levels of activity are generally associated with better outcomes. The distributions of all physical activity variables will be assessed for outliers.'}, {'measure': 'Overall Diet Quality According to the Healthy Eating Index-2015 (HEI-2015)', 'timeFrame': 'Assessed at 12 weeks of pregnancy', 'description': 'The HEI-2015 reflects adherence to the 2015-2020 Dietary Guidelines for Americans; it is comprised of 13 components as well as an overall score. The scoring system ranges from 0 to 100, where higher values indicate a better diet quality.'}, {'measure': 'Postpartum Weight Retention', 'timeFrame': 'Assessed at 6 weeks postpartum'}, {'measure': 'The Proportion of Infants With Appropriate Birthweight (>10th and <90th Percentile of Sex-, Gestational Age-, and Racial/Ethnic-specific Distribution)', 'timeFrame': 'Assessed at birth'}, {'measure': 'Infant Growth (BMI Z-score)', 'timeFrame': 'From birth to 12 months of age'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Gestational weight gain', 'Lifestyle', 'Intervention', 'Body weight', 'Overweight', 'Obesity', 'Signs and Symptoms', 'Body weight changes'], 'conditions': ['Gestational Weight Gain']}, 'referencesModule': {'references': [{'pmid': '39710337', 'type': 'BACKGROUND', 'citation': 'Sridhar SB, Ferrara A, Brown SD, Quesenberry CP, Xu F, Liu E, Sedgwick T, Kissel P, Serrato Bandera HD, Albright C, Hedderson MM. Protocol of an adaptive mobile health intervention for the management of gestational weight gain: The LEAP cluster randomized controlled trial. Contemp Clin Trials. 2025 Feb;149:107781. doi: 10.1016/j.cct.2024.107781. Epub 2024 Dec 20.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this trial is to investigate the effectiveness of a mobile health (mhealth) intervention to help overweight and obese women achieve appropriate gestational weight gain (GWG) for their pre-pregnancy body mass index (BMI). The goal of the intervention is to help women achieve GWG within the range recommended by the Institute of Medicine. The investigators propose an adaptive intervention that begins with an effective, yet low resource-intensive treatment and then provides incremental support and resources only to patients who need them. The intervention includes: 1) an mHealth tool allowing data to be automatically transmitted to a mobile website; 2) personalized text messages; and 3) personalized 1:1 telephone coaching sessions. The latter more intensive components are reserved for patients whose GWG is not within the IOM guidelines. The lifestyle intervention will be delivered through 1 telephone counseling session with a study dietician trained in motivational interviewing techniques, as well as through technology-based tools, automated text messages and weekly e-mails of core lifestyle intervention sessions. Personalized text messages and 1:1 telephone coaching sessions will be given to those who are not meeting the GWG guidelines. The lifestyle intervention will be compared to usual medical care. Maternal outcomes will be assessed shortly before delivery and at 6 weeks postpartum. Infant birthweight and weight at one year will also be assessed.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '21 Years', 'genderBased': True, 'genderDescription': 'This study is only enrolling female participants.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Pregnant\n* Women receiving prenatal care at Kaiser Permanente San Francisco and Oakland and whose obstetric care clinicians consent to participate;\n* Pregravid BMI 25 to \\<40 (as determined from a measured pregravid weight in electronic medical record);\n* Has access to a smartphone and Wi-Fi;\n* Provides informed consent to participate.\n\nExclusion Criteria:\n\n* Multiple births;\n* Planning to move out of the area during the study period;\n* Inability to speak, read, or understand English;\n* Placed on bed rest at time of enrollment; -\\>15 weeks' gestation at enrollment."}, 'identificationModule': {'nctId': 'NCT03880461', 'briefTitle': 'A Mobile Health Intervention to Achieve Appropriate Gestational Weight Gain in Overweight/Obese Women', 'organization': {'class': 'OTHER', 'fullName': 'Kaiser Permanente'}, 'officialTitle': 'Cluster Randomized Trial of a Mobile Health Intervention to Achieve Appropriate Gestational Weight Gain in Overweight/Obese Women', 'orgStudyIdInfo': {'id': '1352535-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lifestyle Intervention', 'description': 'The goal of the intervention is to help women achieve GWG within the range recommended by the Institute of Medicine. The lifestyle intervention will be delivered through 1 telephone counseling session with a study dietician trained in motivational interviewing techniques, as well as through technology-based tools, automated text messages and weekly e-mails of core lifestyle intervention sessions. Personalized text messages and 1:1 telephone coaching sessions will be given to those who are not meeting the GWG guidelines.', 'interventionNames': ['Behavioral: Lifestyle Intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Usual Care - Control', 'description': 'Usual Medical Care'}], 'interventions': [{'name': 'Lifestyle Intervention', 'type': 'BEHAVIORAL', 'description': 'Behavioral lifestyle intervention', 'armGroupLabels': ['Lifestyle Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94612', 'city': 'Oakland', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente Oakland', 'geoPoint': {'lat': 37.80437, 'lon': -122.2708}}, {'zip': '94063', 'city': 'Redwood City', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente Redwood City', 'geoPoint': {'lat': 37.48522, 'lon': -122.23635}}, {'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '95051', 'city': 'Santa Clara', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente Santa Clara', 'geoPoint': {'lat': 37.35411, 'lon': -121.95524}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kaiser Permanente', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}