The ADAPT Trial: Adapting Evidence-Based Obesity Interventions in Community Settings

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-12
SponsorVanderbilt University Medical Center

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Child with an age ≥ 6 years and < 12 years

Child body mass index ≥95th percentile for age and sex on standardized CDC growth curves

Index parent/legal guardian with an age ≥18 years

Parent and child speak English or Spanish

Disqualifiers

Participant child has been diagnosed with Down Syndrome, Autism, or any other developmental disorders that impact metabolism or behaviors that would preclude participation in group physical activity settings;

Either the participant caregiver or child is unable to participate in light to moderate physical activity;

Participant caregiver has a serious mental or neurologic illness that impairs ability to consent/participate.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Competency Based Approaches to Community Health (COACH)

    Behavioral

    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.

Treatment groups

750 Participants
are divided into 2 treatment groups
Group A: COACH InterventionExperimental treatment 1 intervention
Group B: Adaptation ArmActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Child Percent of the 95th Body Mass Index Percentile

Calculated from CDC growth curves

Time frame
6 months post randomization

Secondary outcomes

1

Child Percent of the 95th Body Mass Index Percentile

Calculated from CDC growth curves

Time frame
6 weeks post randomization

Other outcomes

1

Child Diet

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
2

Child Physical Activity

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
3

Child Media Use

Child Media Use Index

Time frame
6 months post randomization
4

Child Sleep

Children's Sleep Habits Questionnaire

Time frame
6 months post randomization

Sponsors and contacts

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