Parent and Family Obesity Intervention in Reducing Obesity Risk in Racial Ethnic Minority Families

Study Overview
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Brief Summary
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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.

Detailed Description
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PRIMARY OBJECTIVE: I. Establish the feasibility and acceptability of the Parent and Family obesity interventions. SECONDARY OBJECTIVES: I. Explore congregational and community interest in obesity and obesity related behaviors in racial ethnic minorities. II. 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). OUTLINE: Churches are randomized to 1 of 3 arms. ARM 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. ARM 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. ARM 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.

Official Title
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A Family-Based Approach to Reducing Obesity Risk Among African American Families

Conditions
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Obesity-Related Malignant Neoplasm

Intervention / Treatment
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* Behavioral: Behavioral Intervention
* Other: Counseling
* Procedure: Discussion
* Other: Educational Intervention
* Other: Informational Intervention
* Other: Interview


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ELIGIBLE IN-DEPTH INTERVIEW PARTICIPANTS: Any church leader, such as pastors, minister, church secretary, health ministry leader, youth leader, deacons, ministry leader, director PARENT-CHILD DYADS: Be parent/caregiver (legal parent or custodial grandparent; male or female) and child willing to participate PARENT-CHILD DYADS: Live together in the same household PARENTS/CAREGIVERS: Self-identify as a racial ethnic minority (i.e., black or African American or Hispanic) PARENTS/CAREGIVERS: Parent or caregiver age 18 through 65 years old PARENTS/CAREGIVERS: Are obese (body mass index [BMI] >= 30) PARENTS/CAREGIVERS: Are not currently participating in a physical activity (PA), diet, or weight management program PARENTS/CAREGIVERS: Enroll with a child aged 10-16 years PARENTS/CAREGIVERS: Have a valid home address, telephone number, and internet access PARENTS/CAREGIVERS: Are able to speak, read, and write in English CHILDREN: They are aged between 10-16 years Exclusion Criteria: PARENTS/CAREGIVERS: They are currently pregnant or thinking about becoming pregnant during study period PARENTS/CAREGIVERS: They present any contraindications for exercise based on responses to the PA Readiness Questionnaire PARENTS/CAREGIVERS: Principal investigator (PI) determines that parent/caregiver is unsuitable for the study for reasons not otherwise stated in the protocol

Ages Eligible for Study
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Minimum Age: 10 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: Arm I (parent intervention)<br>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. | Behavioral: Behavioral Intervention<br>* Receive peer support sessions<br>* Other names: Behavioral Treatments;Other: Counseling<br>* Receive health coaching sessions<br>* Other names: Counseling Intervention;Procedure: Discussion<br>* Attend focus groups<br>* Other names: Discuss;Other: Educational Intervention<br>* Receive handbook<br>* Other names: Intervention, Educational;Other: Informational Intervention<br>* Receive navigation sessions<br>Other: Interview<br>* Participate in interview<br>|
| Experimental: Arm II (family intervention)<br>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. | Behavioral: Behavioral Intervention<br>* Receive peer support sessions<br>* Other names: Behavioral Treatments;Other: Counseling<br>* Receive health coaching sessions<br>* Other names: Counseling Intervention;Procedure: Discussion<br>* Attend focus groups<br>* Other names: Discuss;Other: Educational Intervention<br>* Receive handbook<br>* Other names: Intervention, Educational;Other: Informational Intervention<br>* Receive navigation sessions<br>Other: Interview<br>* Participate in interview<br>|
| Active Comparator: Arm III (delayed comparison)<br>Participants receive a handbook that includes core content from the parent and family interventions, but without individual support from coaches, LHWs or the church. | Procedure: Discussion<br>* Attend focus groups<br>* Other names: Discuss;Other: Educational Intervention<br>* Receive handbook<br>* Other names: Intervention, Educational;Other: Interview<br>* Participate in interview<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The correlation between the feasibility of the Parent and Family obesity interventions. |  | Up to 4 years | 
| The correlation between the acceptability of the Parent and Family obesity interventions. |  | Up to 4 years |