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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04644224.
PRIMARY OBJECTIVES:
I. Determine whether a parent/caregiver intervention or a family intervention can produce greater weight loss among obese racial ethnic minority parents at 3 months compared to a Cancer Prevention Group (control).
II. Use the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) model, to evaluate individual community 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, racial ethnic minority children at risk for obesity at 3 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 3 months, 3 resource navigation sessions over 3 months, and monthly support groups for 3 months.
GROUP II: Families whose churches are randomized to Group II, attend monthly health coaching sessions over 1 hour each for 3 months, 3 resource navigation sessions over 3 months, and monthly support groups for 3 months.
GROUP III: Families whose churches are randomized to Group III, receive an educational handbook on cancer prevention.
Trial PhaseNo phase specified
Trial Typeprevention
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorLorna McNeill