Ignite Creation Date:
2025-12-25 @ 3:39 AM
Ignite Modification Date:
2026-03-03 @ 7:53 AM
Study NCT ID:
NCT02787902
Status:
COMPLETED
Last Update Posted:
2021-10-12
First Post:
2016-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Weight Management in Mothers and Adult Daughters
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-11', 'studyFirstSubmitDate': '2016-02-22', 'studyFirstSubmitQcDate': '2016-05-26', 'lastUpdatePostDateStruct': {'date': '2021-10-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Weight change', 'timeFrame': '16 weeks', 'description': 'Change in weight from baseline to post-intervention (16 weeks).'}], 'secondaryOutcomes': [{'measure': 'Anthropometrics', 'timeFrame': 'baseline and post-intervention (16 weeks)'}, {'measure': 'Blood pressure', 'timeFrame': 'baseline and post-intervention (16 weeks)'}, {'measure': 'Communication', 'timeFrame': 'baseline and post-intervention (16 weeks)'}, {'measure': 'Relationship factors (dyad, family, social networks)', 'timeFrame': 'baseline and post-intervention (16 weeks)'}, {'measure': 'Psychosocial factors', 'timeFrame': 'baseline and post-intervention (16 weeks)'}, {'measure': 'Eating behavior', 'timeFrame': 'baseline and post-intervention (16 weeks)'}, {'measure': 'Physical activity', 'timeFrame': 'baseline and post-intervention (16 weeks)'}, {'measure': 'Weight control behavior', 'timeFrame': 'baseline and post-intervention (16 weeks)'}, {'measure': 'Treatment attendance and adherence', 'timeFrame': 'between baseline and post-intervention (16 weeks)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Overweight or Obese']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to develop, implement, and evaluate a behavioral weight management intervention with a communication training component for Mexican-American women. The study has three specific aims.\n\nAim 1: Develop a behavioral weight loss intervention that modifies evidence-based behavioral weight loss treatment using results from formative data collected from Mexican-American mother-daughter dyads. The adapted intervention will focus on improving dyadic communication and collaboration for providing reciprocal support for healthy eating and physical activity behaviors.\n\nAim 2: Implement and evaluate a pilot weight management program adapted for mother-daughter dyads. Dyads will be randomly assigned to partner-based treatment with or without communication skills training.\n\nAim 3: Evaluate associations between changes in weight, weight-related behaviors, and psychosocial variables with changes in measures assessing interpersonal communication.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female\n* Body mass index of 25-50 kg/m2\n* Mexican or Mexican-American\n\nExclusion Criteria:\n\n* Pregnancy or plans to become pregnant in the next year\n* 5% weight loss in the last 3 months\n* History of bariatric surgery\n* Serious medical condition or psychological disorder'}, 'identificationModule': {'nctId': 'NCT02787902', 'briefTitle': 'Weight Management in Mothers and Adult Daughters', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Diego'}, 'officialTitle': 'Improving Communication and Collaboration for Weight Management in Mother-daughter', 'orgStudyIdInfo': {'id': '151345'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Communication', 'description': 'Behavioral weight loss program with communication skills training', 'interventionNames': ['Behavioral: Communication']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard', 'description': 'Standard behavioral weight loss program', 'interventionNames': ['Behavioral: Standard']}], 'interventions': [{'name': 'Communication', 'type': 'BEHAVIORAL', 'description': 'Behavioral weight management program adapted for mother-daughter dyads with communication skills training', 'armGroupLabels': ['Communication']}, {'name': 'Standard', 'type': 'BEHAVIORAL', 'description': 'Behavioral weight management program adapted for mother-daughter dyads without communication skills training', 'armGroupLabels': ['Standard']}]}, 'contactsLocationsModule': {'locations': [{'zip': '93093', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'University of California San Diego', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Diego', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Becky Marquez', 'investigatorAffiliation': 'University of California, San Diego'}}}}