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

Primary Purpose

Obesity-Related Malignant Neoplasm

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Behavioral Intervention
Counseling
Discussion
Educational Intervention
Informational Intervention
Interview
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity-Related Malignant Neoplasm

Eligibility Criteria

10 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • M D Anderson Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Arm I (parent intervention)

Arm II (family intervention)

Arm III (delayed comparison)

Arm Description

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.

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 15, 2021
Last Updated
August 15, 2023
Sponsor
M.D. Anderson Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT05094466
Brief Title
Parent and Family Obesity Intervention in Reducing Obesity Risk in Racial Ethnic Minority Families
Official Title
A Family-Based Approach to Reducing Obesity Risk Among African American Families
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 16, 2019 (Actual)
Primary Completion Date
February 2, 2027 (Anticipated)
Study Completion Date
February 2, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity-Related Malignant Neoplasm

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm I (parent intervention)
Arm Type
Experimental
Arm Description
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.
Arm Title
Arm II (family intervention)
Arm Type
Experimental
Arm Description
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 Title
Arm III (delayed comparison)
Arm Type
Active Comparator
Arm Description
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 Type
Behavioral
Intervention Name(s)
Behavioral Intervention
Other Intervention Name(s)
Behavior Conditioning Therapy, Behavior Modification, Behavior or Life Style Modifications, Behavior Therapy, Behavioral Interventions, Behavioral Modification, Behavioral Therapy, Behavioral Treatment, Behavioral Treatments
Intervention Description
Receive peer support sessions
Intervention Type
Other
Intervention Name(s)
Counseling
Other Intervention Name(s)
Counseling Intervention
Intervention Description
Receive health coaching sessions
Intervention Type
Procedure
Intervention Name(s)
Discussion
Other Intervention Name(s)
Discuss
Intervention Description
Attend focus groups
Intervention Type
Other
Intervention Name(s)
Educational Intervention
Other Intervention Name(s)
Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Intervention Description
Receive handbook
Intervention Type
Other
Intervention Name(s)
Informational Intervention
Intervention Description
Receive navigation sessions
Intervention Type
Other
Intervention Name(s)
Interview
Intervention Description
Participate in interview
Primary Outcome Measure Information:
Title
The correlation between the feasibility of the Parent and Family obesity interventions.
Time Frame
Up to 4 years
Title
The correlation between the acceptability of the Parent and Family obesity interventions.
Time Frame
Up to 4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lorna McNeill, PhD
Phone
(713) 563-1103
Email
lmcneill@mdanderson.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lorna McNeill, PhD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lorna McNeill
Phone
713-563-1103
Email
lmcneill@mdanderson.org
First Name & Middle Initial & Last Name & Degree
Lorna McNeill

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
M D Anderson Cancer Center

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

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