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Parent and Family Oriented Support Interventions for the Facilitation of Weight Loss in African American Families

Primary Purpose

Obesity-Related Malignant Neoplasm

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Educational Activity
Educational Intervention
Informational Intervention
Questionnaire Administration
Support Group Therapy
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 - 65 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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 black or African American
  • PARENT/CAREGIVER: Parent or caregiver age 18 through 65 years old
  • PARENT/CAREGIVER: Are obese (BMI greater than or equal to 30)
  • 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 10-16 years
  • PARENT/CAREGIVER: Are able to speak English
  • CHILDREN: They are aged between 10-16 years

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 (PAR-Q)

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

Group I (coaching session, navigation session, support group)

Group II (coaching session, navigation session, support group)

Group III (educational handbook)

Arm Description

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.

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.

Families whose churches are randomized to Group III, receive an educational handbook on cancer prevention.

Outcomes

Primary Outcome Measures

Weight loss of parents
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.
Reach (Part 1 of the RE-AIM framework)
Measured as the number of churches invited to participate, number enrolled, and differences between the two groups.
Effectiveness (Part 2 of the RE-AIM framework)
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.
Adoption (Part 3 of the RE-AIM framework)
Will be measured by asking churches about factors that helped or hindered adoption or implementation and will they adopt intervention when completed.
Implementation (Part 4 of the RE-AIM framework)
Measured as study attendance and assessments, number of health coaching, LHW and support group sessions, number of staff training, and self-monitoring practices.
Maintenance (Part 5 of the RE-AIM framework)
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 Outcome Measures

Child's body mass index (BMI) z-score
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.
Fruit and vegetable consumption
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.
Physical activity
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.
Blood pressure
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.
Body fat percentage
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.
Waist circumference
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.

Full Information

First Posted
October 21, 2020
Last Updated
June 15, 2023
Sponsor
M.D. Anderson Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT04644224
Brief Title
Parent and Family Oriented Support Interventions for the Facilitation of Weight Loss in African American Families
Official Title
A Peer and Family-Based Approach to Obesity in African American Families
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 17, 2019 (Actual)
Primary Completion Date
December 31, 2028 (Anticipated)
Study Completion Date
December 31, 2028 (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 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.
Detailed Description
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.

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
1632 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group I (coaching session, navigation session, support group)
Arm Type
Experimental
Arm Description
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.
Arm Title
Group II (coaching session, navigation session, support group)
Arm Type
Experimental
Arm Description
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.
Arm Title
Group III (educational handbook)
Arm Type
Active Comparator
Arm Description
Families whose churches are randomized to Group III, receive an educational handbook on cancer prevention.
Intervention Type
Other
Intervention Name(s)
Educational Activity
Intervention Description
Attend health coaching session
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
Attend resource navigation session
Intervention Type
Other
Intervention Name(s)
Informational Intervention
Intervention Description
Receive handbook
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Intervention Type
Procedure
Intervention Name(s)
Support Group Therapy
Intervention Description
Attend support group
Primary Outcome Measure Information:
Title
Weight loss of parents
Description
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.
Time Frame
Up to 18 months
Title
Reach (Part 1 of the RE-AIM framework)
Description
Measured as the number of churches invited to participate, number enrolled, and differences between the two groups.
Time Frame
Up to 18 months
Title
Effectiveness (Part 2 of the RE-AIM framework)
Description
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.
Time Frame
Up to 18 months
Title
Adoption (Part 3 of the RE-AIM framework)
Description
Will be measured by asking churches about factors that helped or hindered adoption or implementation and will they adopt intervention when completed.
Time Frame
Up to 18 months
Title
Implementation (Part 4 of the RE-AIM framework)
Description
Measured as study attendance and assessments, number of health coaching, LHW and support group sessions, number of staff training, and self-monitoring practices.
Time Frame
Up to 18 months
Title
Maintenance (Part 5 of the RE-AIM framework)
Description
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.
Time Frame
Up to 18 months
Secondary Outcome Measure Information:
Title
Child's body mass index (BMI) z-score
Description
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.
Time Frame
Up to 18 months
Title
Fruit and vegetable consumption
Description
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.
Time Frame
Up to 18 months
Title
Physical activity
Description
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.
Time Frame
Up to 18 months
Title
Blood pressure
Description
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.
Time Frame
Up to 18 months
Title
Body fat percentage
Description
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.
Time Frame
Up to 18 months
Title
Waist circumference
Description
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.
Time Frame
Up to 18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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 black or African American PARENT/CAREGIVER: Parent or caregiver age 18 through 65 years old PARENT/CAREGIVER: Are obese (BMI greater than or equal to 30) 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 10-16 years PARENT/CAREGIVER: Are able to speak English CHILDREN: They are aged between 10-16 years 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 (PAR-Q)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lorna McNeill
Phone
713-563-1103
Email
lmcneill@mdanderson.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lorna McNeill
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
First Name & Middle Initial & Last Name & Degree
Lorna McNeill

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
MD Anderson Cancer Center Website

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Parent and Family Oriented Support Interventions for the Facilitation of Weight Loss in African American Families

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