Ignite Creation Date:
2025-12-24 @ 4:21 PM
Ignite Modification Date:
2025-12-29 @ 12:20 AM
Study NCT ID:
NCT05094466
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-30
First Post:
2021-09-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Parent and Family Obesity Intervention in Reducing Obesity Risk in Racial Ethnic Minority Families
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D003376', 'term': 'Counseling'}, {'id': 'D018479', 'term': 'Early Intervention, Educational'}, {'id': 'D004522', 'term': 'Educational Status'}, {'id': 'D008722', 'term': 'Methods'}, {'id': 'D007407', 'term': 'Interviews as Topic'}], 'ancestors': [{'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D008605', 'term': 'Mental Health Services'}, {'id': 'D003153', 'term': 'Community Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D002662', 'term': 'Child Health Services'}, {'id': 'D011314', 'term': 'Preventive Health Services'}, {'id': 'D012959', 'term': 'Socioeconomic Factors'}, {'id': 'D011154', 'term': 'Population Characteristics'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-07-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2027-02-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-28', 'studyFirstSubmitDate': '2021-09-15', 'studyFirstSubmitQcDate': '2021-10-13', 'lastUpdatePostDateStruct': {'date': '2025-07-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-02-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The correlation between the feasibility of the Parent and Family obesity interventions.', 'timeFrame': 'Up to 4 years'}, {'measure': 'The correlation between the acceptability of the Parent and Family obesity interventions.', 'timeFrame': 'Up to 4 years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity-Related Malignant Neoplasm']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'M D Anderson Cancer Center'}]}, 'descriptionModule': {'briefSummary': 'This clinical trial compares the effects of parent/caregiver-focused programs to family-focused programs in reducing obesity risk in racial ethnic minority families. Obesity tends to run in families, thus family-based interventions have been strongly recommended. Parent and family obesity programs may reduce obesity risk and ultimately reduce the risk of obesity-related cancer.', 'detailedDescription': 'PRIMARY OBJECTIVE:\n\nI. Establish the feasibility and acceptability of the Parent and Family obesity interventions.\n\nSECONDARY OBJECTIVES:\n\nI. Explore congregational and community interest in obesity and obesity related behaviors in racial ethnic minorities.\n\nII. Explore the preliminary impact of the Parent and Family interventions on behavioral, social and environmental outcomes in parent/child dyads. III. Explore potential mediators (self-efficacy, perceived stress, depressive symptoms) and moderators (sex of dyads, family history of lifestyle changes, and church attendance).\n\nOUTLINE: Churches are randomized to 1 of 3 arms.\n\nARM I (PARENT INTERVENTION): Parents receive health coaching sessions over 50-60 minutes monthly for 6 months. Parents also receive navigation sessions with a lay health worker (LHW) monthly for 6 months and church-based peer support monthly for 6 months.\n\nARM II (FAMILY INTERVENTION): Family members receive health coaching sessions over 50-60 minutes monthly for 6 months. Family members also receive navigation sessions with a LHW monthly for 6 months and church-based peer support monthly for 6 months.\n\nARM III (DELAYED COMPARISON): Participants receive a handbook that includes core content from the parent and family interventions, but without individual support from coaches, LHWs or the church.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '10 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ELIGIBLE IN-DEPTH INTERVIEW PARTICIPANTS: Any church leader, such as pastors, minister, church secretary, health ministry leader, youth leader, deacons, ministry leader, director\n* PARENT-CHILD DYADS: Be parent/caregiver (legal parent or custodial grandparent; male or female) and child willing to participate\n* PARENT-CHILD DYADS: Live together in the same household\n* PARENTS/CAREGIVERS: Self-identify as a racial ethnic minority (i.e., black or African American or Hispanic)\n* PARENTS/CAREGIVERS: Parent or caregiver age 18 through 65 years old\n* PARENTS/CAREGIVERS: Are obese (body mass index \\[BMI\\] \\>= 30)\n* PARENTS/CAREGIVERS: Are not currently participating in a physical activity (PA), diet, or weight management program\n* PARENTS/CAREGIVERS: Enroll with a child aged 10-16 years\n* PARENTS/CAREGIVERS: Have a valid home address, telephone number, and internet access\n* PARENTS/CAREGIVERS: Are able to speak, read, and write in English\n* CHILDREN: They are aged between 10-16 years\n\nExclusion Criteria:\n\n* PARENTS/CAREGIVERS: They are currently pregnant or thinking about becoming pregnant during study period\n* PARENTS/CAREGIVERS: They present any contraindications for exercise based on responses to the PA Readiness Questionnaire\n* PARENTS/CAREGIVERS: Principal investigator (PI) determines that parent/caregiver is unsuitable for the study for reasons not otherwise stated in the protocol'}, 'identificationModule': {'nctId': 'NCT05094466', 'briefTitle': 'Parent and Family Obesity Intervention in Reducing Obesity Risk in Racial Ethnic Minority Families', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'A Family-Based Approach to Reducing Obesity Risk Among African American Families', 'orgStudyIdInfo': {'id': '2017-0557'}, 'secondaryIdInfos': [{'id': 'NCI-2021-09374', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '2017-0557', 'type': 'OTHER', 'domain': 'M D Anderson Cancer Center'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm I (parent intervention)', 'description': 'Parents receive health coaching sessions over 50-60 minutes monthly for 6 months. Parents also receive navigation sessions with a lay LHW monthly for 6 months and church-based peer support monthly for 6 months.', 'interventionNames': ['Behavioral: Behavioral Intervention', 'Other: Counseling', 'Procedure: Discussion', 'Other: Educational Intervention', 'Other: Informational Intervention', 'Other: Interview']}, {'type': 'EXPERIMENTAL', 'label': 'Arm II (family intervention)', 'description': 'Family members receive health coaching sessions over 50-60 minutes monthly for 6 months. Family members also receive navigation sessions with a LHW monthly for 6 months and church-based peer support monthly for 6 months.', 'interventionNames': ['Behavioral: Behavioral Intervention', 'Other: Counseling', 'Procedure: Discussion', 'Other: Educational Intervention', 'Other: Informational Intervention', 'Other: Interview']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm III (delayed comparison)', 'description': 'Participants receive a handbook that includes core content from the parent and family interventions, but without individual support from coaches, LHWs or the church.', 'interventionNames': ['Procedure: Discussion', 'Other: Educational Intervention', 'Other: Interview']}], 'interventions': [{'name': 'Behavioral Intervention', 'type': 'BEHAVIORAL', 'otherNames': ['Behavior Conditioning Therapy', 'Behavior Modification', 'Behavior or Life Style Modifications', 'Behavior Therapy', 'Behavioral Interventions', 'Behavioral Modification', 'Behavioral Therapy', 'Behavioral Treatment', 'Behavioral Treatments'], 'description': 'Receive peer support sessions', 'armGroupLabels': ['Arm I (parent intervention)', 'Arm II (family intervention)']}, {'name': 'Counseling', 'type': 'OTHER', 'otherNames': ['Counseling Intervention'], 'description': 'Receive health coaching sessions', 'armGroupLabels': ['Arm I (parent intervention)', 'Arm II (family intervention)']}, {'name': 'Discussion', 'type': 'PROCEDURE', 'otherNames': ['Discuss'], 'description': 'Attend focus groups', 'armGroupLabels': ['Arm I (parent intervention)', 'Arm II (family intervention)', 'Arm III (delayed comparison)']}, {'name': 'Educational Intervention', 'type': 'OTHER', 'otherNames': ['Education for Intervention', 'Intervention by Education', 'Intervention through Education', 'Intervention, Educational'], 'description': 'Receive handbook', 'armGroupLabels': ['Arm I (parent intervention)', 'Arm II (family intervention)', 'Arm III (delayed comparison)']}, {'name': 'Informational Intervention', 'type': 'OTHER', 'description': 'Receive navigation sessions', 'armGroupLabels': ['Arm I (parent intervention)', 'Arm II (family intervention)']}, {'name': 'Interview', 'type': 'OTHER', 'description': 'Participate in interview', 'armGroupLabels': ['Arm I (parent intervention)', 'Arm II (family intervention)', 'Arm III (delayed comparison)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'M D Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Lorna McNeill, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}