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Active, Not Recruiting

NCT Number: NCT04644224

Parent and Family Oriented Support Interventions for the Facilitation of Weight Loss 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

10 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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:

  • None.

Treatment and study plan

Educational Activity

Other

Attend health coaching session

Educational Intervention

Other

Attend resource navigation session

Other names: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

Informational intervention

Other

Receive handbook

Questionnaire Administration

Other

Ancillary studies

support group therapy

Procedure

Attend support group

Primary outcomes

  1. Weight loss of parents

    Time frame: Up 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.

  2. Reach (Part 1 of the RE-AIM framework)

    Time frame: Up to 18 months

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

  3. Effectiveness (Part 2 of the RE-AIM framework)

    Time frame: 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.

  4. Adoption (Part 3 of the RE-AIM framework)

    Time frame: 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.

  5. Implementation (Part 4 of the RE-AIM framework)

    Time frame: 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.

  6. Maintenance (Part 5 of the RE-AIM framework)

    Time frame: 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.

Secondary outcomes

  1. Child's body mass index (BMI) z-score

    Time frame: Up to 18 months

    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.

  2. Fruit and vegetable consumption

    Time frame: Up to 18 months

    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.

  3. Physical activity

    Time frame: Up to 18 months

    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.

  4. Blood pressure

    Time frame: Up to 18 months

    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.

  5. Body fat percentage

    Time frame: Up to 18 months

    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.

  6. Waist circumference

    Time frame: Up to 18 months

    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.

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2028
Study completion
2028
First posted
Nov 25, 2020
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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