Parent and Family Oriented Support Interventions for the Facilitation of Weight Loss in African American Families
A Peer and Family-Based Approach to Obesity in African American Families
2 other identifiers
interventional
81
1 country
1
Brief Summary
This study tests the effectiveness of parent and family oriented support interventions that are designed to help with weight loss among African American families. Obesity tends to run in families, thus family based interventions, with parents as main change agents have been strongly recommended. The parent and family oriented support Interventions may help facilitate weight loss among African American families.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 17, 2019
CompletedFirst Submitted
Initial submission to the registry
October 21, 2020
CompletedFirst Posted
Study publicly available on registry
November 25, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
January 9, 2026
January 1, 2026
10 years
October 21, 2020
January 7, 2026
Conditions
Outcome Measures
Primary Outcomes (6)
Weight loss of parents
Will use the generalized linear mixed model (GLMM) regression, which takes into account both within-cluster (e.g., within church) and, as applicable, within-individual (e.g., overtime) correlations between observations of each primary and secondary outcomes of interest.
Up to 18 months
Reach (Part 1 of the RE-AIM framework)
Measured as the number of churches invited to participate, number enrolled, and differences between the two groups.
Up to 18 months
Effectiveness (Part 2 of the RE-AIM framework)
Measured as the impact on weight loss: 6 focus groups and 15 individual interviews at 18 months to understand unanticipated outcomes; interview lay health workers (LHWs) about implementation.
Up to 18 months
Adoption (Part 3 of the RE-AIM framework)
Will be measured by asking churches about factors that helped or hindered adoption or implementation and will they adopt intervention when completed.
Up to 18 months
Implementation (Part 4 of the RE-AIM framework)
Measured as study attendance and assessments, number of health coaching, LHW and support group sessions, number of staff training, and self-monitoring practices.
Up to 18 months
Maintenance (Part 5 of the RE-AIM framework)
Long-term maintenance in parent/families at 18 months measured by family and church attrition, to assess church's ability to maintain employment of LHWs and their willingness to remain in this role.
Up to 18 months
Secondary Outcomes (6)
Child's body mass index (BMI) z-score
Up to 18 months
Fruit and vegetable consumption
Up to 18 months
Physical activity
Up to 18 months
Blood pressure
Up to 18 months
Body fat percentage
Up to 18 months
- +1 more secondary outcomes
Study Arms (3)
Group I (coaching session, navigation session, support group)
EXPERIMENTALParents/caregivers whose churches are randomized to Group I, attend monthly health coaching sessions over 1 hour each for 12 months, 9 resource navigation sessions over 12 months, and monthly support groups for 12 months.
Group II (coaching session, navigation session, support group)
EXPERIMENTALFamilies whose churches are randomized to Group II, attend monthly health coaching sessions over 1 hour each for 12 months, 9 resource navigation sessions over 12 months, and monthly support groups for 12 months.
Group III (educational handbook)
ACTIVE COMPARATORFamilies whose churches are randomized to Group III, receive an educational handbook on cancer prevention.
Interventions
Attend health coaching session
Attend resource navigation session
Ancillary studies
Attend support group
Eligibility Criteria
You may qualify if:
- DYAD: Be parent/caregiver (legal parent or custodial grandparent; male or female) and child willing to participate
- DYAD: Live together in the same household
- PARENT/CAREGIVER: Self-identify as a racial ethic minority (i.e., black or African American or Hispanic)
- PARENT/CAREGIVER: Parent or caregiver age 18 through 65 years old
- PARENT/CAREGIVER: Are overweight (BMI greater than or equal to 25);
- PARENT/CAREGIVER: Are not currently participating in a physical activity (PA), diet, or weight management program
- PARENT/CAREGIVER: Have a valid home address, telephone number, and internet access
- PARENT/CAREGIVER: Enroll with a child aged 8-17 years
- PARENT/CAREGIVER: Are able to speak English
You may not qualify if:
- PARENT/CAREGIVER: They are currently pregnant or thinking about becoming pregnant during the study period
- PARENT/CAREGIVER: They present any contraindications for exercise based on responses to the PA Readiness Questionnaire plus (PAR-Q +)
- \) None.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
M D Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lorna McNeill
M.D. Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 21, 2020
First Posted
November 25, 2020
Study Start
January 17, 2019
Primary Completion (Estimated)
December 31, 2028
Study Completion (Estimated)
December 31, 2028
Last Updated
January 9, 2026
Record last verified: 2026-01