Parent and Family Oriented Support Interventions for the Facilitation of Weight Loss in African American Families

Not Applicable

Recruiting

• Conditions: Obesity-Related Malignant Neoplasm
• Interventions: Other: Educational Activity; Other: Informational Intervention; Other: Educational Intervention; Other: Questionnaire Administration; Procedure: Support Group Therapy

• Registration Number: NCT04644224
• Lead Sponsor: M.D. Anderson Cancer Center

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.

Detailed Description

PRIMARY OBJECTIVES:

I. Determine whether a parent/caregiver intervention or a family intervention can produce greater weight loss among obese African American (AA) parents at 12 months compared to a cancer prevention group (control).

II. Use the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) model, to evaluate individual and church-level barriers and facilitators on program reach, effectiveness, adoption, implementation, maintenance and dissemination.

SECONDARY OBJECTIVES:

I. Explore whether a parent/caregiver intervention and a family intervention can produce weight maintenance or weight loss, as determined by change in body mass index (BMI) z-score, among AA children at risk for obesity at 12 months compared to the control group.

II. Determine the extent to which the proposed interventions improve fruit and vegetable (FV) consumption, physical activity, blood pressure, body fat percentage, muscle mass and waist circumference.

OUTLINE: Churches are randomized to 1 of 3 groups.

GROUP I: Parents/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: Families 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: Families whose churches are randomized to Group III, receive an educational handbook on cancer prevention.

Study Timeline

• Study Start: 2019-01-17
• Study First Submitted: 2020-10-21
• Study First Submitted QC: 2020-11-24
• Study First Posted: 2020-11-25
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-07
• Last Update Posted: 2024-03-08
• Primary Completion: 2028-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1200

Inclusion Criteria

• 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 black or African American
• PARENT/CAREGIVER: Parent or caregiver age 18 through 65 years old
• PARENT/CAREGIVER: Are obese (BMI greater than or equal to 30)
• 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 10-16 years
• PARENT/CAREGIVER: Are able to speak English
• CHILDREN: They are aged between 10-16 years

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Exclusion Criteria

• 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 (PAR-Q)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group I (coaching session, navigation session, support group)	Questionnaire Administration	Parents/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)	Educational Activity	Families 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 II (coaching session, navigation session, support group)	Educational Intervention	Families 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 I (coaching session, navigation session, support group)	Educational Intervention	Parents/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)	Questionnaire Administration	Families 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 I (coaching session, navigation session, support group)	Educational Activity	Parents/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 I (coaching session, navigation session, support group)	Support Group Therapy	Parents/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 III (educational handbook)	Questionnaire Administration	Families whose churches are randomized to Group III, receive an educational handbook on cancer prevention.
Group II (coaching session, navigation session, support group)	Support Group Therapy	Families 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)	Informational Intervention	Families whose churches are randomized to Group III, receive an educational handbook on cancer prevention.

Primary Outcome Measures

Name	Time	Method
Adoption (Part 3 of the RE-AIM framework)	Up to 18 months	Will be measured by asking churches about factors that helped or hindered adoption or implementation and will they adopt intervention when completed.
Maintenance (Part 5 of the RE-AIM framework)	Up to 18 months	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.
Weight loss of parents	Up to 18 months	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.
Effectiveness (Part 2 of the RE-AIM framework)	Up to 18 months	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.
Implementation (Part 4 of the RE-AIM framework)	Up to 18 months	Measured as study attendance and assessments, number of health coaching, LHW and support group sessions, number of staff training, and self-monitoring practices.
Reach (Part 1 of the RE-AIM framework)	Up to 18 months	Measured as the number of churches invited to participate, number enrolled, and differences between the two groups.

Secondary Outcome Measures

Name	Time	Method
Waist circumference	Up to 18 months	Will use the 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.
Child's body mass index (BMI) z-score	Up to 18 months	Will use the 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.
Blood pressure	Up to 18 months	Will use the 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.
Body fat percentage	Up to 18 months	Will use the 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.
Physical activity	Up to 18 months	Will use the 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.
Fruit and vegetable consumption	Up to 18 months	Will use the 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.

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States