Clinical trial NCT04644224: Parent and Family Oriented Support Interventions for the Facilitation of Weight Loss in African American Families
Official title: A Peer and Family-Based Approach to Obesity in African American Families
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity-Related Malignant Neoplasm
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2020-11-25
Enrollment: 1200
Sex: ALL
Minimum age (years): 10
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Weight loss of parents
timeFrame: Up to 18 months
measure: Reach (Part 1 of the RE-AIM framework)
timeFrame: Up to 18 months
measure: Effectiveness (Part 2 of the RE-AIM framework)
timeFrame: Up to 18 months
measure: Adoption (Part 3 of the RE-AIM framework)
timeFrame: Up to 18 months
measure: Implementation (Part 4 of the RE-AIM framework)
timeFrame: Up to 18 months
measure: Maintenance (Part 5 of the RE-AIM framework)
timeFrame: Up to 18 months
Secondary outcomes:
measure: Child's body mass index (BMI) z-score
timeFrame: Up to 18 months
measure: Fruit and vegetable consumption
timeFrame: Up to 18 months
measure: Physical activity
timeFrame: Up to 18 months
measure: Blood pressure
timeFrame: Up to 18 months
measure: Body fat percentage
timeFrame: Up to 18 months
measure: Waist circumference
timeFrame: Up to 18 months
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Lorna McNeill
role: PRINCIPAL_INVESTIGATOR
References: