Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2026-01-04 @ 12:16 PM
Study NCT ID:
NCT02924051
Status:
COMPLETED
Last Update Posted:
2019-07-22
First Post:
2016-10-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Interventions in Nutrition Education and Skills
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D062405', 'term': 'Motivational Interviewing'}], 'ancestors': [{'id': 'D037001', 'term': 'Directive Counseling'}, {'id': 'D003376', 'term': 'Counseling'}, {'id': 'D008605', 'term': 'Mental Health Services'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'fdbowe2@uky.edu', 'phone': '(859) 257-4866', 'title': 'Dr. Frances Hardin-Fanning', 'organization': 'University of Kentucky'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data were monitored over the entire 12 month period of the study. No adverse or serious adverse events were reported in this study.', 'description': 'Adverse event monitoring was based on Clinical Trials definitions.', 'eventGroups': [{'id': 'EG000', 'title': 'Control', 'description': 'Control group received cookbooks, cooking classes, food preparation tools and prepared food dishes to take home to their families.', 'otherNumAtRisk': 82, 'deathsNumAtRisk': 82, 'otherNumAffected': 0, 'seriousNumAtRisk': 82, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Intervention', 'description': 'Intervention group participants received cookbooks, cooking classes, food preparation tools and prepared food dishes to take home to their families, along with monthly motivational interviewing conducted by a trained registered nurse.\n\nMotivational Interviewing: Baseline and monthly assessment of barriers/facilitators of dietary change, ambivalence to change and "coaching" to resolve barriers and ambivalence.', 'otherNumAtRisk': 106, 'deathsNumAtRisk': 106, 'otherNumAffected': 0, 'seriousNumAtRisk': 106, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in BLOCK Fruit/Vegetable/Fiber Screener From Baseline at 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cooking Skills/Nutrition Education', 'description': 'Control group received cookbooks, cooking classes, food preparation tools and prepared food dishes to take home to families.'}, {'id': 'OG001', 'title': 'Cooking Skills/Nutrition Education/Motivational Interviewing', 'description': 'Intervention group participants received cookbooks, cooking classes, food preparation tools and prepared food dishes to take home to their families, along with monthly motivational interviewing conducted by a trained registered nurse.\n\nMotivational Interviewing: Baseline and monthly assessment of barriers/facilitators of dietary change, ambivalence to change and "coaching" to resolve barriers and ambivalence.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '16.6', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '34'}, {'value': '15.9', 'groupId': 'OG001', 'lowerLimit': '5', 'upperLimit': '30'}]}]}, {'title': '12 months', 'categories': [{'measurements': [{'value': '18.0', 'groupId': 'OG000', 'lowerLimit': '6', 'upperLimit': '35'}, {'value': '16.3', 'groupId': 'OG001', 'lowerLimit': '6', 'upperLimit': '29'}]}]}], 'analyses': [{'pValue': '0.26', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.12', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'With an alpha level of .05 and effective (post-attrition) sample size of approximately 25 participants per county, and 3 counties per treatment group, the power of the group comparison was at least 80%, assuming an ICC of .01 or less, and an observed difference in proportions of .25. The anticipated power for the longitudinal comparison of continuous outcomes was expected to be even greater under these assumptions given the greater power for the parametric tests.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 12 months', 'description': 'Block Fruit/Vegetable/Fiber Screener is a tool that ranks usual intake of fruit, vegetables, and fiber. Total fruit/vegetable/fiber score can range from 0-50 with higher numbers reflecting greater frequency of fruit, vegetable and fiber consumption.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the Block Screener at baseline and post-intervention (12 months)'}, {'type': 'SECONDARY', 'title': 'Average Saturated Fatty Acid Intake/Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cooking Skills/Nutrition Education', 'description': 'Participants in the control group received cookbooks, cooking classes, food preparation tools and prepared food dishes to take home to their families.\n\nMotivational Interviewing: Baseline and monthly assessment of barriers/facilitators of dietary change, ambivalence to change and "coaching" to resolve barriers and ambivalence.'}, {'id': 'OG001', 'title': 'Cooking Skills/Nutrition Education/Motivational Interviewing', 'description': 'Intervention group participants received cookbooks, cooking classes, food preparation tools and prepared food dishes to take home to their families, along with monthly motivational interviewing conducted by a trained registered nurse.\n\nMotivational Interviewing: Baseline and monthly assessment of barriers/facilitators of dietary change, ambivalence to change and "coaching" to resolve barriers and ambivalence.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '26.8', 'spread': '15.4', 'groupId': 'OG000'}, {'value': '23.8', 'spread': '14.3', 'groupId': 'OG001'}]}]}, {'title': 'Post-Intervention (12 mos)', 'categories': [{'measurements': [{'value': '19.2', 'spread': '9.6', 'groupId': 'OG000'}, {'value': '21.6', 'spread': '17.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 12 months', 'description': "Using the NCI DHQ II, respondents' frequency of consumption of foods (i.e., meats and oils) and portion size, dietary saturated fat consumption was calculated as average grams/day. Higher grams/day reflect higher consumption of saturated fatty acids.", 'unitOfMeasure': 'grams/day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants completing the NCI DHQ II survey'}, {'type': 'SECONDARY', 'title': 'Frequency of Fast Food Consumption', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cooking Skills/Nutrition Education', 'description': 'Control group received cookbooks, cooking classes, food preparation tools and prepared food dishes to take home to families.'}, {'id': 'OG001', 'title': 'Cooking Skills/Nutrition Education/MI', 'description': 'Intervention group participants received cookbooks, cooking classes, food preparation tools and prepared food dishes to take home to their families, along with monthly motivational interviewing conducted by a trained registered nurse.\n\nMotivational Interviewing: Baseline and monthly assessment of barriers/facilitators of dietary change, ambivalence to change and "coaching" to resolve barriers and ambivalence.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '3.56', 'spread': '.49', 'groupId': 'OG000'}, {'value': '3.16', 'spread': '0.53', 'groupId': 'OG001'}]}]}, {'title': '12 months', 'categories': [{'measurements': [{'value': '3.78', 'spread': '0.50', 'groupId': 'OG000'}, {'value': '3.03', 'spread': '0.46', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.36', 'groupIds': ['OG001'], 'groupDescription': 'Comparison of Cooking Skills/Nutrition Education/MI at baseline and 12 months.', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 months', 'description': 'Fast food consumption was measured using a single item on the National Cancer Institute Diety History Questionaire (NCI DHQ II) "How often did you eat beef hamburgers or cheeseburgers from a fast food or other restaurant?" Responses are selected from 11 pre-determined options increasing in frequency from "never" to "2 or more times per day." Values range from 0 to 10; higher values indicate an increased frequency of fast food consumption.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants completing the NCI DHQ II question related fast food comsumpsion'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cooking Skills/Nutrition Education', 'description': 'Control group received cookbooks, cooking classes, food preparation tools and prepared food dishes to take home to their families.'}, {'id': 'FG001', 'title': 'Cooking Skills/Nutrition Education/Motivational Interviewing', 'description': 'Intervention group participants received cookbooks, cooking classes, food preparation tools and prepared food dishes to take home to their families, along with monthly motivational interviewing conducted by a trained registered nurse.\n\nMotivational Interviewing: Baseline and monthly assessment of barriers/facilitators of dietary change, ambivalence to change and "coaching" to resolve barriers and ambivalence.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '82'}, {'groupId': 'FG001', 'numSubjects': '106'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '81'}, {'groupId': 'FG001', 'numSubjects': '97'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '9'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'BG000'}, {'value': '106', 'groupId': 'BG001'}, {'value': '188', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Control', 'description': 'Control group received cookbooks, cooking classes, food preparation tools and prepared food dishes to take home to families.'}, {'id': 'BG001', 'title': 'Intervention', 'description': 'Intervention group participants received cookbooks, cooking classes, food preparation tools and prepared food dishes to take home to their families, along with monthly motivational interviewing conducted by a trained registered nurse.\n\nMotivational Interviewing: Baseline and monthly assessment of barriers/facilitators of dietary change, ambivalence to change and "coaching" to resolve barriers and ambivalence.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55.4', 'groupId': 'BG000', 'lowerLimit': '16', 'upperLimit': '81'}, {'value': '50.3', 'groupId': 'BG001', 'lowerLimit': '19', 'upperLimit': '76'}, {'value': '54.9', 'groupId': 'BG002', 'lowerLimit': '16', 'upperLimit': '81'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '77', 'groupId': 'BG000'}, {'value': '99', 'groupId': 'BG001'}, {'value': '176', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], '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'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '79', 'groupId': 'BG000'}, {'value': '104', 'groupId': 'BG001'}, {'value': '183', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '82', 'groupId': 'BG000'}, {'value': '106', 'groupId': 'BG001'}, {'value': '188', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Control/Intervention Groups (3 sites in each group)'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 188}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-22', 'studyFirstSubmitDate': '2016-10-03', 'resultsFirstSubmitDate': '2017-04-17', 'studyFirstSubmitQcDate': '2016-10-04', 'lastUpdatePostDateStruct': {'date': '2019-07-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-05-22', 'studyFirstPostDateStruct': {'date': '2016-10-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-07-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in BLOCK Fruit/Vegetable/Fiber Screener From Baseline at 12 Months', 'timeFrame': 'Baseline, 12 months', 'description': 'Block Fruit/Vegetable/Fiber Screener is a tool that ranks usual intake of fruit, vegetables, and fiber. Total fruit/vegetable/fiber score can range from 0-50 with higher numbers reflecting greater frequency of fruit, vegetable and fiber consumption.'}], 'secondaryOutcomes': [{'measure': 'Average Saturated Fatty Acid Intake/Day', 'timeFrame': 'Baseline, 12 months', 'description': "Using the NCI DHQ II, respondents' frequency of consumption of foods (i.e., meats and oils) and portion size, dietary saturated fat consumption was calculated as average grams/day. Higher grams/day reflect higher consumption of saturated fatty acids."}, {'measure': 'Frequency of Fast Food Consumption', 'timeFrame': 'Baseline and 12 months', 'description': 'Fast food consumption was measured using a single item on the National Cancer Institute Diety History Questionaire (NCI DHQ II) "How often did you eat beef hamburgers or cheeseburgers from a fast food or other restaurant?" Responses are selected from 11 pre-determined options increasing in frequency from "never" to "2 or more times per day." Values range from 0 to 10; higher values indicate an increased frequency of fast food consumption.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'Healthy eating can be difficult for people who live in poor, geographically isolated regions of the United States. In particular, people who live in Appalachia often experience food insecurity (i.e., their access to adequate food is limited by a lack of money and other resources at times during the year) and lack of access to healthy foods. This pilot study evaluates the effectiveness of motivational interviewing in helping individuals who live in these austere regions improve their diets in the context of limited resources and healthy food availability', 'detailedDescription': 'Participants in three of the counties will receive an education/skills intervention paired with a form of coaching called motivational interviewing (MI) conducted by a trained registered nurse. Three similar counties that do not border any of the intervention counties are serving as controls (these counties receive the same nutrition education/skills intervention without motivational interviewing). All participants will receive cookbooks, cooking classes, food preparation tools, and prepared food dishes to take home to their families. The investigators will measure the impact of motivational interviewing on fresh fruit and vegetable consumption, saturated fat consumption and number of meals cooked at home.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n• People who live in one of six rural Kentucky food desert counties\n\nExclusion Criteria:\n\n* \\<16 years old\n* Unable to read/write English\n* Any GI malabsorption disorder that prevents high fiber consumption'}, 'identificationModule': {'nctId': 'NCT02924051', 'briefTitle': 'Interventions in Nutrition Education and Skills', 'organization': {'class': 'OTHER', 'fullName': 'University of Kentucky'}, 'officialTitle': 'Interventions in Nutrition Education and Skills', 'orgStudyIdInfo': {'id': '14-0020-P2H'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Motivational Interview (MI)', 'description': 'Intervention group participants receive cooking skills and nutritional education via cookbooks, cooking classes, food preparation tools and prepared food dishes to take home to their families, along with monthly motivational interviewing conducted by a trained registered nurse', 'interventionNames': ['Behavioral: Motivational Interviewing']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cooking Skills/Nutritional Education', 'description': 'Participants in this arm receive cooking skills and nutritional education via cookbooks, cooking classes, food preparation tools and prepared food dishes to take home to their families.', 'interventionNames': ['Behavioral: Cooking skills and nutritional education']}], 'interventions': [{'name': 'Motivational Interviewing', 'type': 'BEHAVIORAL', 'description': 'Baseline and monthly assessment of barriers/facilitators of dietary change, ambivalence to change and "coaching" to resolve barriers and ambivalence.', 'armGroupLabels': ['Motivational Interview (MI)']}, {'name': 'Cooking skills and nutritional education', 'type': 'BEHAVIORAL', 'description': 'Participants in this group will develop an understanding of healthy food options and healthy food preparation.', 'armGroupLabels': ['Cooking Skills/Nutritional Education']}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF', 'CSR'], 'timeFrame': 'Will be available upon request June 30, 2018 (following publication/presentation of primary/secondary outcome results). Data will be available for 6 years.', 'ipdSharing': 'YES', 'description': 'Data being compiled', 'accessCriteria': 'Data, free of identifiers, will be provided in Excel spreadsheets to requesting researchers to the PI via email (fdbowe2@uky.edu) after June 30, 2018. Both the University of Kentucky Medical IRB and Data Safety Monitoring Board will be asked to review the request prior to release. Researchers must state purpose of the request, intent of data analysis, and acknowledge the PI in subsequent publications/presentations by signing the University of Ky College of Nursing Data Use Agreement and Letter of Intent.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Frances Hardin-Fanning, PhD, RN', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Frances Hardin-Fanning, PhD, RN', 'investigatorAffiliation': 'University of Kentucky'}}}}