M D Anderson Cancer Center
Houston, Texas, 77030, United States
NCT Number: NCT04644224
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.
This study is active but is not currently recruiting participants.
Notify Me10 year–65 year
All sexes
Interventional
Not applicable
Houston, Texas, 77030, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Exclusion criteria
for child:
Attend health coaching session
Attend resource navigation session
Other names: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Receive handbook
Ancillary studies
Attend support group
Time frame: Up to 18 months
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
Measured as the number of churches invited to participate, number enrolled, and differences between the two groups.
Time frame: Up to 18 months
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
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
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
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
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
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
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
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
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
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.
M.D. Anderson Cancer Center
Other
A Peer and Family-Based Approach to Obesity in African American Families
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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