TrialGlobe

Clinical trial

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

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT04644224

Active, not recruitingNot applicableInterventional

What this study is 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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age10 Years to 65 Years
SexAll
Healthy volunteersAccepted
ConditionObesity-Related Malignant Neoplasm

Full registry 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.

Treatments and study arms

Educational Activity

Other

Attend health coaching session

Educational Intervention

Other

Attend resource navigation session

Informational Intervention

Other

Receive handbook

Questionnaire Administration

Other

Ancillary studies

Support Group Therapy

Procedure

Attend support group

Primary outcomes

Weight loss of parentsUp to 18 months

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.

Reach (Part 1 of the RE-AIM framework)Up to 18 months

Measured as the number of churches invited to participate, number enrolled, and differences between the two groups.

Effectiveness (Part 2 of the RE-AIM framework)Up to 18 months

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.

Adoption (Part 3 of the RE-AIM framework)Up to 18 months

Will be measured by asking churches about factors that helped or hindered adoption or implementation and will they adopt intervention when completed.

Implementation (Part 4 of the RE-AIM framework)Up to 18 months

Measured as study attendance and assessments, number of health coaching, LHW and support group sessions, number of staff training, and self-monitoring practices.

Maintenance (Part 5 of the RE-AIM framework)Up to 18 months

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.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

M D Anderson Cancer Center🇺🇸 Houston, Texas, United States
Open map