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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Peer and Family-Based Approach to Obesity in African American Families

Conditions
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Obesity-Related Malignant Neoplasm

Intervention / Treatment
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* Other: Educational Activity
* Other: Educational Intervention
* Other: Informational Intervention
* Other: Questionnaire Administration
* Procedure: Support Group Therapy


Participation Criteria
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Eligibility Criteria
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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 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)

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group I (coaching session, navigation session, support group)<br>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. | Other: Educational Activity<br>* Attend health coaching session<br>Other: Educational Intervention<br>* Attend resource navigation session<br>* Other names: Intervention, Educational;Other: Questionnaire Administration<br>* Ancillary studies<br>Procedure: Support Group Therapy<br>* Attend support group<br>|
| Experimental: Group II (coaching session, navigation session, support group)<br>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. | Other: Educational Activity<br>* Attend health coaching session<br>Other: Educational Intervention<br>* Attend resource navigation session<br>* Other names: Intervention, Educational;Other: Questionnaire Administration<br>* Ancillary studies<br>Procedure: Support Group Therapy<br>* Attend support group<br>|
| Active Comparator: Group III (educational handbook)<br>Families whose churches are randomized to Group III, receive an educational handbook on cancer prevention. | Other: Informational Intervention<br>* Receive handbook<br>Other: Questionnaire Administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child's body mass index (BMI) z-score | 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. | Up to 18 months | 
| Fruit and vegetable consumption | 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. | Up to 18 months | 
| Physical activity | 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. | Up to 18 months | 
| Blood pressure | 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. | Up to 18 months | 
| Body fat percentage | 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. | Up to 18 months | 
| Waist circumference | 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. | Up to 18 months |