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

A Peer and Family-Based Approach to Obesity in African American Families

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 Overview

• Status: Active, not recruiting
• Conditions: Obesity-Related Malignant Neoplasm
• Intervention / Treatment: Other: Questionnaire Administration; Other: Educational Activity; Other: Educational Intervention; Procedure: Support Group Therapy; Other: Informational Intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 81
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • M D Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group I (coaching session, navigation session, support group); 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.	Other: Questionnaire Administration; Ancillary studies; Other: Educational Activity; Attend health coaching session; Other: Educational Intervention; Attend resource navigation session; Other Names: Education for Intervention; Intervention by Education; Intervention through Education; Intervention, Educational; Procedure: Support Group Therapy; Attend support group
Experimental: Group II (coaching session, navigation session, support group); 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.	Other: Questionnaire Administration; Ancillary studies; Other: Educational Activity; Attend health coaching session; Other: Educational Intervention; Attend resource navigation session; Other Names: Education for Intervention; Intervention by Education; Intervention through Education; Intervention, Educational; Procedure: Support Group Therapy; Attend support group
Active Comparator: Group III (educational handbook); Families whose churches are randomized to Group III, receive an educational handbook on cancer prevention.	Other: Questionnaire Administration; Ancillary studies; Other: Informational Intervention; Receive handbook

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight loss of parents	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.	Up to 18 months
Reach (Part 1 of the RE-AIM framework)	Measured as the number of churches invited to participate, number enrolled, and differences between the two groups.	Up to 18 months
Effectiveness (Part 2 of the RE-AIM framework)	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.	Up to 18 months
Adoption (Part 3 of the RE-AIM framework)	Will be measured by asking churches about factors that helped or hindered adoption or implementation and will they adopt intervention when completed.	Up to 18 months
Implementation (Part 4 of the RE-AIM framework)	Measured as study attendance and assessments, number of health coaching, LHW and support group sessions, number of staff training, and self-monitoring practices.	Up to 18 months
Maintenance (Part 5 of the RE-AIM framework)	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.	Up to 18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Child's body mass index (BMI) z-score	Will use the 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.	Up to 18 months
Fruit and vegetable consumption	Will use the 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.	Up to 18 months
Physical activity	Will use the 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.	Up to 18 months
Blood pressure	Will use the 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.	Up to 18 months
Body fat percentage	Will use the 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.	Up to 18 months
Waist circumference	Will use the 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.	Up to 18 months

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Investigators: Principal Investigator: Lorna McNeill, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• MD Anderson Cancer Center Website

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2019
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: October 21, 2020
• First Submitted That Met QC Criteria: November 24, 2020
• First Posted (Actual): November 25, 2020

Study Record Updates

• Last Update Posted (Actual): January 9, 2026
• Last Update Submitted That Met QC Criteria: January 7, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Neoplasms; Obesity; Investigative Techniques; Health Services; Health Care Facilities Workforce and Services; Child Health Services; Community Health Services; Preventive Health Services; Socioeconomic Factors; Population Characteristics; Methods; Early Intervention, Educational; Educational Status
• Other Study ID Numbers: 2017-0827 (Other Identifier: M D Anderson Cancer Center); NCI-2020-07645 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No