NCT05094466

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
6mo left

Started Jul 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress93%
Jul 2019Feb 2027

Study Start

First participant enrolled

July 16, 2019

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

September 15, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 26, 2021

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 2, 2027

Last Updated

July 16, 2026

Status Verified

July 1, 2026

Enrollment Period

7.6 years

First QC Date

September 15, 2021

Last Update Submit

July 14, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • The correlation between the feasibility of the Parent and Family obesity interventions.

    Up to 4 years

  • The correlation between the acceptability of the Parent and Family obesity interventions.

    Up to 4 years

Study Arms (3)

Arm I (parent intervention)

EXPERIMENTAL

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.

Behavioral: Behavioral InterventionOther: CounselingProcedure: DiscussionOther: Educational InterventionOther: Informational InterventionOther: Interview

Arm II (family intervention)

EXPERIMENTAL

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.

Behavioral: Behavioral InterventionOther: CounselingProcedure: DiscussionOther: Educational InterventionOther: Informational InterventionOther: Interview

Arm III (delayed comparison)

ACTIVE COMPARATOR

Participants receive a handbook that includes core content from the parent and family interventions, but without individual support from coaches, LHWs or the church.

Procedure: DiscussionOther: Educational InterventionOther: Interview

Interventions

Receive peer support sessions

Also known as: Behavior Conditioning Therapy, Behavior Modification, Behavior or Life Style Modifications, Behavior Therapy, Behavioral Interventions, Behavioral Modification, Behavioral Therapy, Behavioral Treatment, Behavioral Treatments
Arm I (parent intervention)Arm II (family intervention)

Receive health coaching sessions

Also known as: Counseling Intervention
Arm I (parent intervention)Arm II (family intervention)
DiscussionPROCEDURE

Attend focus groups

Also known as: Discuss
Arm I (parent intervention)Arm II (family intervention)Arm III (delayed comparison)

Receive handbook

Also known as: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Arm I (parent intervention)Arm II (family intervention)Arm III (delayed comparison)

Receive navigation sessions

Arm I (parent intervention)Arm II (family intervention)

Participate in interview

Arm I (parent intervention)Arm II (family intervention)Arm III (delayed comparison)

Eligibility Criteria

Age10 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Interventions

Behavior TherapyCounselingEarly Intervention, EducationalEducational StatusMethodsInterviews as Topic

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and ActivitiesMental Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesChild Health ServicesPreventive Health ServicesSocioeconomic FactorsPopulation CharacteristicsInvestigative TechniquesData CollectionEpidemiologic MethodsHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Lorna McNeill, PhD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2021

First Posted

October 26, 2021

Study Start

July 16, 2019

Primary Completion (Estimated)

February 2, 2027

Study Completion (Estimated)

February 2, 2027

Last Updated

July 16, 2026

Record last verified: 2026-07

Locations