NCT05094466

Active, Not Recruiting

N/A

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

M.D. Anderson Cancer Center1 site in 1 country120 target enrollmentJuly 16, 2019

ConditionsObesity-Related Malignant Neoplasm

InterventionsDiscussion Behavioral Intervention Counseling Educational Intervention Informational Intervention Interview

Overview

Phase: N/A
Intervention: Discussion
Conditions: Obesity-Related Malignant Neoplasm
Sponsor: M.D. Anderson Cancer Center
Enrollment: 120
Locations: 1
Primary Endpoint: The correlation between the acceptability of the Parent and Family obesity interventions.
Status: Active, Not Recruiting
Last Updated: 3 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

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.

Registry

clinicaltrials.gov

Start Date

July 16, 2019

End Date

February 2, 2027

Last Updated

3 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

M.D. Anderson Cancer Center

Responsible Party

Sponsor

Eligibility Criteria

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

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

Arms & Interventions

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.

Intervention: Discussion

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.

Intervention: Behavioral Intervention

Arm I (parent intervention)

Intervention: Counseling

Arm I (parent intervention)

Intervention: Discussion

Arm I (parent intervention)

Intervention: Educational Intervention

Arm I (parent intervention)

Intervention: Informational Intervention

Arm I (parent intervention)

Intervention: Interview

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.

Intervention: Discussion

Arm II (family intervention)

Intervention: Behavioral Intervention

Arm II (family intervention)

Intervention: Counseling

Arm II (family intervention)

Intervention: Educational Intervention

Arm II (family intervention)

Intervention: Informational Intervention

Arm II (family intervention)

Intervention: Interview

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.

Intervention: Interview

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.

Intervention: Educational Intervention