Parent and Family Obesity Intervention in Reducing Obesity Risk in Racial Ethnic Minority Families

January 7, 2026 updated by: M.D. Anderson Cancer Center

A Family-Based Approach to Reducing Obesity Risk Among African American Families

This clinical trial compares the effects of parent/caregiver-focused programs to family-focused programs in reducing obesity risk in racial ethnic minority families. Obesity tends to run in families, thus family-based interventions have been strongly recommended. Parent and family obesity programs may reduce obesity risk and ultimately reduce the risk of obesity-related cancer.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVE:

I. Establish the feasibility and acceptability of the Parent and Family obesity interventions.

SECONDARY OBJECTIVES:

I. Explore congregational and community interest in obesity and obesity related behaviors in racial ethnic minorities.

II. Explore the preliminary impact of the Parent and Family interventions on behavioral, social and environmental outcomes in parent/child dyads. III. Explore potential mediators (self-efficacy, perceived stress, depressive symptoms) and moderators (sex of dyads, family history of lifestyle changes, and church attendance).

OUTLINE: Churches are randomized to 1 of 3 arms.

ARM I (PARENT INTERVENTION): Parents receive health coaching sessions over 50-60 minutes monthly for 6 months. Parents also receive navigation sessions with a lay health worker (LHW) monthly for 6 months and church-based peer support monthly for 6 months.

ARM II (FAMILY INTERVENTION): Family members receive health coaching sessions over 50-60 minutes monthly for 6 months. Family members also receive navigation sessions with a LHW monthly for 6 months and church-based peer support monthly for 6 months.

ARM III (DELAYED COMPARISON): Participants receive a handbook that includes core content from the parent and family interventions, but without individual support from coaches, LHWs or the church.

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • ELIGIBLE IN-DEPTH INTERVIEW PARTICIPANTS: Any church leader, such as pastors, minister, church secretary, health ministry leader, youth leader, deacons, ministry leader, director
  • PARENT-CHILD DYADS: Be parent/caregiver (legal parent or custodial grandparent; male or female) and child willing to participate
  • PARENT-CHILD DYADS: Live together in the same household
  • PARENTS/CAREGIVERS: Self-identify as a racial ethnic minority (i.e., black or African American or Hispanic)
  • PARENTS/CAREGIVERS: Parent or caregiver age 18 through 65 years old
  • PARENTS/CAREGIVERS: Are obese (body mass index [BMI] >= 30)
  • PARENTS/CAREGIVERS: Are not currently participating in a physical activity (PA), diet, or weight management program
  • PARENTS/CAREGIVERS: Enroll with a child aged 10-16 years
  • PARENTS/CAREGIVERS: Have a valid home address, telephone number, and internet access
  • PARENTS/CAREGIVERS: Are able to speak, read, and write in English
  • CHILDREN: They are aged between 10-16 years

Exclusion Criteria:

  • PARENTS/CAREGIVERS: They are currently pregnant or thinking about becoming pregnant during study period
  • PARENTS/CAREGIVERS: They present any contraindications for exercise based on responses to the PA Readiness Questionnaire
  • PARENTS/CAREGIVERS: Principal investigator (PI) determines that parent/caregiver is unsuitable for the study for reasons not otherwise stated in the protocol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm I (parent intervention)
Parents receive health coaching sessions over 50-60 minutes monthly for 6 months. Parents also receive navigation sessions with a lay LHW monthly for 6 months and church-based peer support monthly for 6 months.
Other: Interview
Participate in interview
Behavioral: Behavioral Intervention
Receive peer support sessions
Other Names:
  • Behavior Conditioning Therapy
  • Behavior Modification
  • Behavior or Life Style Modifications
  • Behavior Therapy
  • Behavioral Interventions
  • Behavioral Modification
  • Behavioral Therapy
  • Behavioral Treatment
  • Behavioral Treatments
Other: Counseling
Receive health coaching sessions
Other Names:
  • Counseling Intervention
Procedure: Discussion
Attend focus groups
Other Names:
  • Discuss
Other: Educational Intervention
Receive handbook
Other Names:
  • Education for Intervention
  • Intervention by Education
  • Intervention through Education
  • Intervention, Educational
Other: Informational Intervention
Receive navigation sessions
Experimental: Arm II (family intervention)
Family members receive health coaching sessions over 50-60 minutes monthly for 6 months. Family members also receive navigation sessions with a LHW monthly for 6 months and church-based peer support monthly for 6 months.
Other: Interview
Participate in interview
Behavioral: Behavioral Intervention
Receive peer support sessions
Other Names:
  • Behavior Conditioning Therapy
  • Behavior Modification
  • Behavior or Life Style Modifications
  • Behavior Therapy
  • Behavioral Interventions
  • Behavioral Modification
  • Behavioral Therapy
  • Behavioral Treatment
  • Behavioral Treatments
Other: Counseling
Receive health coaching sessions
Other Names:
  • Counseling Intervention
Procedure: Discussion
Attend focus groups
Other Names:
  • Discuss
Other: Educational Intervention
Receive handbook
Other Names:
  • Education for Intervention
  • Intervention by Education
  • Intervention through Education
  • Intervention, Educational
Other: Informational Intervention
Receive navigation sessions
Active Comparator: Arm III (delayed comparison)
Participants receive a handbook that includes core content from the parent and family interventions, but without individual support from coaches, LHWs or the church.
Other: Interview
Participate in interview
Procedure: Discussion
Attend focus groups
Other Names:
  • Discuss
Other: Educational Intervention
Receive handbook
Other Names:
  • Education for Intervention
  • Intervention by Education
  • Intervention through Education
  • Intervention, Educational

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The correlation between the feasibility of the Parent and Family obesity interventions.
Time Frame: Up to 4 years
Up to 4 years
The correlation between the acceptability of the Parent and Family obesity interventions.
Time Frame: Up to 4 years
Up to 4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 16, 2019

Primary Completion (Estimated)

February 2, 2027

Study Completion (Estimated)

February 2, 2027

Study Registration Dates

First Submitted

September 15, 2021

First Submitted That Met QC Criteria

October 13, 2021

First Posted (Actual)

October 26, 2021

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

Other Study ID Numbers

  • 2017-0557 (Other Identifier: M D Anderson Cancer Center)
  • NCI-2021-09374 (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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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