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

Obesity-Related Malignant Neoplasm Clinical Trial

Official title:

A Peer and Family-Based Approach to Obesity in African American Families

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04644224
• Other study ID #: 2017-0827
• Secondary ID: NCI-2020-0764520
• Status: Recruiting
• Phase: N/A
• Start date: January 17, 2019
• Est. completion date: December 31, 2028

Study information

• Verified date: March 2024
• Source: M.D. Anderson Cancer Center
• Contact: Lorna McNeill
• Phone: 713-563-1103
• Email: lmcneill[@]mdanderson.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Neoplasms
• Obesity
• Obesity-Related Malignant Neoplasm

Intervention

Other:
• Educational Activity
Attend health coaching session
• Educational Intervention
Attend resource navigation session
• Informational Intervention
Receive handbook
• Questionnaire Administration
Ancillary studies

Procedure:
• Support Group Therapy
Attend support group

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 18 months
Primary	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.	Up to 18 months
Primary	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.	Up to 18 months
Primary	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.	Up to 18 months
Primary	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.	Up to 18 months
Primary	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.	Up to 18 months
Secondary	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.	Up to 18 months
Secondary	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.	Up to 18 months
Secondary	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.	Up to 18 months
Secondary	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.	Up to 18 months
Secondary	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.	Up to 18 months
Secondary	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.	Up to 18 months

External Links

•   MD Anderson Cancer Center Website