Vanderbilt University Medical Center
Nashville, Tennessee, 37212, United States
Location status: Recruiting
NCT Number: NCT06546696
Evidence-based obesity treatment is inaccessible to most children in the United States. This lack of access is a source of health inequity, whereby children from rural and minority communities, who have the highest rates of childhood obesity, are also the least likely to receive an evidence-based intervention. Developing strategies to improve access to evidence-based obesity interventions could reduce health disparities by improving reach to these underserved communities. The premise of this study is that using a systematic framework to adapt a community-based behavioral intervention for childhood obesity that accounts for individual, family, and community factors will increase reach and effectiveness among low-income, minority, and rural populations. COACH is a multi-level obesity intervention that supports 1) the individual child through developmentally appropriate health behavior curriculum, 2) the family by directly addressing parent weight loss and engaging parents as agents of change for their children, and 3) the community by building the capacity of local community centers to offer parent-child programming. The investigators propose testing the process of adapting COACH in a cluster-randomized trial.
Interested in participating?
Request Info6 year–12 year
All sexes
Interventional
Not applicable
Nashville, Tennessee, 37212, United States
Location status: Recruiting
In Aim 1, the investigators will conduct a community readiness assessment for COACH in 50 community centers serving rural, minority, and low-income families in middle TN. In 25 randomly selected community centers, the investigators will use a systematic process to adapt the intervention protocol based on the assessment results, while maintaining fidelity to COACH's core components. In Aim 2, in a cluster-randomized trial, the investigators will test the comparative effectiveness of each implementation strategy (adaptation vs. original program) on the implementation outcomes of reach, adoption, implementation, and maintenance. In Aim 3, the investigators will test the comparative effectiveness of the adapted and original intervention.
This research is innovative because it uses adaptation science as a potential solution to reduce health disparities in childhood obesity. By testing this intervention in a community resource available to 230 million Americans (community centers), the investigators aim to create a scalable obesity intervention that could be implemented in traditionally underserved populations across the country. This study will also develop and test a theory-based process for adapting behavioral interventions for both obesity and other health outcomes among diverse rural and urban communities.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
COACH is a multi-level intervention, consisting of 1) developmentally appropriate health curriculum for children; 2) family-based content that both targets parent weight loss and leverages a shared parent-child experience to improve family health behaviors; 3) community-level intervention to improve access and quality of family-based programming at local Parks and Rec centers.
Other names: COACH
Time frame: 6 months post randomization
Calculated from CDC growth curves
Time frame: 6 weeks post randomization
Calculated from CDC growth curves
Time frame: 6 months post randomization
Child Nutrition and Physical Activity Behavior Scale. Possible range of 0-9 with higher scores indicating healthier diet and physical activity practices.
Time frame: 6 months post randomization
Child Nutrition and Physical Activity Behavior Scale. Possible range of 0-9 with higher scores indicating healthier diet and physical activity practices.
Time frame: 6 months post randomization
Child Media Use Index
Time frame: 6 months post randomization
Children's Sleep Habits Questionnaire
Time frame: 6 weeks post randomization
Measured by study staff
Time frame: 6 months post randomization
Measured by study staff
Contact information is provided by the study sponsor or research team.
Laura Adams, RD, MBA
CONTACT
William J Heerman, MD, MPH
CONTACT
Vanderbilt University Medical Center
Other
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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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