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

M.D. Anderson Cancer Center

Status: Active, not recruiting

Conditions: Obesity-Related Malignant Neoplasm

Treatments: Other: Educational Intervention; Other: Educational Activity; Other: Informational Intervention; Procedure: Support Group Therapy; Other: Questionnaire Administration

Study type: Interventional

Funder types: Other

Identifiers

NCT04644224

2017-0827 (Other Identifier)

NCI-2020-07645 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 81 patients

Sex: All

Ages: 10 to 65 years old

Volunteers: Accepts Healthy Volunteers

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 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

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 plus (PAR-Q +)

Exclusion criteria for child:

1) None.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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81 participants in 3 patient groups

Group I (coaching session, navigation session, support group)

Experimental group

Description:

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.

Treatment:

Other: Questionnaire Administration

Procedure: Support Group Therapy

Other: Educational Activity

Other: Educational Intervention

Group II (coaching session, navigation session, support group)

Experimental group

Description:

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.

Treatment:

Other: Questionnaire Administration

Procedure: Support Group Therapy

Other: Educational Activity

Other: Educational Intervention

Group III (educational handbook)

Active Comparator group

Description:

Families whose churches are randomized to Group III, receive an educational handbook on cancer prevention.

Treatment:

Other: Questionnaire Administration

Other: Informational Intervention