COACH for Childhood Obesity

Overseen By Laura Adams, RD, MBA

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Vanderbilt University Medical Center

Disqualifiers: Down syndrome, Autism, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

750 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications. It is best to consult with the trial coordinators for specific guidance.

What data supports the effectiveness of the treatment COACH for Childhood Obesity?

The COACH program is a personalized, family-centered approach that has shown promise in helping children manage obesity by focusing on diet, physical activity, sleep, and parenting. It uses regular assessments and tailored strategies to support health behavior changes, with a primary goal of improving children's body mass index over a year. ^{1 2 3 4 5}

Is the COACH program safe for children?

The COACH program, which focuses on childhood obesity, involves family-centered and community-based activities like diet and physical activity improvements. While the studies do not specifically mention safety concerns, the program is designed to be supportive and adaptive, suggesting it is generally safe for children. ^{1 3 6 7 8}

How is the COACH treatment for childhood obesity different from other treatments?

The COACH treatment is unique because it is a family-centered, community-based intervention that is individually tailored to each child's needs, focusing on diet, physical activity, sleep, media use, and parenting. It uses a mobile health platform for regular assessments and provides personalized strategies through health coaches, aiming to create sustainable health behavior changes in low-income, minority preschool children. ^{1 3 4 6 9}

What is the purpose of 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 is for children with obesity, particularly from low-income, minority, and rural communities who often lack access to evidence-based treatments. It aims to include families in the intervention process.

Inclusion Criteria

Family resides within or frequently visit selected zip codes within Middle TN surrounding the partnering community centers

Parental commitment to participate in a 6-month study

Ability to view online trainings

Exclusion Criteria

My child has a condition like Down Syndrome or Autism affecting their ability to join in group activities.

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

Either I or my child cannot do light to moderate exercise.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention Adaptation

Community centers adapt the COACH intervention protocol based on community readiness assessment results

Varies by community center

Implementation

Implementation of the adapted or original COACH intervention in community centers

6 months

Ongoing sessions at community centers

Follow-up

Participants are monitored for effectiveness of the intervention on various health outcomes

6 months post randomization

Treatment Details

Interventions

• Competency Based Approaches to Community Health (COACH)

Trial Overview The ADAPT Trial is testing COACH, a community health approach that supports obese children through health education, involves parents in weight loss and as change agents for their kids, and empowers local centers to offer programs.

Participant Groups

Group I: COACH Intervention Experimental Treatment 1 Intervention

COACH intervenes at 3 levels: the individual child, the family, and the community. Child-Level Intervention Content: We will direct skill-building lessons toward the child at developmentally appropriate levels. Family-Level Intervention Content: Curricular components for parents are designed to leverage parents as agents of change for their children. As such, the group-based sessions includes realistic goal setting (SMART goals), strategies to navigate barriers, training in physical activity, and group-based accountability. During the session, parents and children will participate in a low to moderate physical activity. Community-Level Content: The intervention is delivered in the context of a widely available community resource, local community centers across Middle Tennessee. Online Platform: All participants will have access to an online on-demand health behavior change curriculum. Modules are self-paced and will take approximately 7 hours.

Group II: Adaptation Arm Active Control 1 Intervention

The core components of the adaptation arm will mirror the COACH intervention arm. Each community center will be guided through a process of adapting the specific intervention content, and as such, will be unique to each of the 25 community centers randomized to this arm. In this way, the study tests the process of adapting the intervention, instead of a specific portfolio of adaptations.

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials

922

Recruited

939,000+

Findings from Research

A quasi-experimental study involving 14 low-income rural communities in the North Central U.S. aims to assess the effectiveness of community coaching in creating sustainable environments for healthy eating and physical activity to prevent childhood obesity over four years.

The study will evaluate the impact of community coaching on enhancing community capacity through mixed-methods analysis, potentially providing a model for future community-based obesity prevention efforts in rural areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A quasi-experimental study to mobilize rural low-income communities to assess and improve the ecological environment to prevent childhood obesity. Peters, P., Gold, A., Abbott, A., et al.[2018]

A randomized control trial involving 60 obese students showed that a self-empowerment-based coaching program significantly reduced total body fat and improved healthy behavior habits compared to a control group.

The intervention group also reported greater improvements in satisfaction related to hobbies, exercise, sleep, and spiritual well-being, indicating a holistic benefit of the coaching approach in managing obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of self-empowerment-based patient-centered care for obese students in primary services: A randomized controlled trial. Dewi, DK., Sekartini, R., Sunardi, D., et al.[2023]

The COACH trial is a 15-week randomized controlled study aimed at reducing childhood obesity among Latino preschool children by providing a personalized, family-centered behavioral intervention that addresses diet, physical activity, sleep, and parenting.

The intervention includes regular assessments and tailored coaching, with the primary goal of improving child body mass index (BMI) over one year, while also targeting secondary outcomes like parent BMI and child waist circumference.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Competency Based Approach to Community Health (COACH): The methods of a family-centered, community-based, individually adaptive obesity randomized trial for pre-school child-parent pairs. Heerman, WJ., Burgess, LE., Escarfuller, J., et al.[2021]

An online interactive community resources map was developed through interviews with parents and community partners, which identified key resources like farmers markets and parks to support behavior change in children at risk for obesity.

Over the 1-year intervention, parent resource empowerment increased significantly, with 76.2% of families engaging in new physical activities and 57.1% shopping at new locations, indicating that community resource mapping can effectively enhance family engagement in healthier behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Community Resource Map to Support Clinical-Community Linkages in a Randomized Controlled Trial of Childhood Obesity, Eastern Massachusetts, 2014-2016. Fiechtner, L., Puente, GC., Sharifi, M., et al.[2019]

Nurses reported that the child-centred health dialogue (CCHD) intervention for addressing childhood overweight was emotionally challenging, but the training they received improved their ability to engage families in discussions about healthy lifestyles.

Despite the emotional difficulties, the structured training provided nurses with tools and support, enhancing their professionalism and effectiveness in conducting health dialogues with children and their caregivers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A challenging balancing act to engage children and their families in a healthy lifestyle - Nurses' experiences of child-centred health dialogue in child health services in Sweden. Castor, C., Derwig, M., Borg, SJ., et al.[2021]

The COACH intervention, a personalized and family-based program, successfully slowed the linear growth of BMI in Latino preschool-aged children over a 1-year period, indicating its potential effectiveness in addressing childhood obesity.

Out of 117 randomized parent-child pairs, the intervention led to a statistically significant reduction in BMI growth of -0.41 kg/m2 per year, suggesting that community-based health coaching can positively impact obesity trajectories in minority populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Competency-Based Approaches to Community Health: A Randomized Controlled Trial to Reduce Childhood Obesity among Latino Preschool-Aged Children. Heerman, WJ., Teeters, L., Sommer, EC., et al.[2021]

The community-academic advisory board (CAB) involved in developing a childhood obesity treatment program showed significant improvements in conflict resolution skills and trust among members, indicating effective collaboration in a medically underserved area.

Despite some positive changes, perceptions of participation and influence decreased significantly, suggesting a need to address engagement strategies in future community-academic partnerships.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

One-Year Mixed-Methods Case Study of a Community-Academic Advisory Board Addressing Childhood Obesity. Zoellner, J., Hill, JL., Brock, D., et al.[2020]

The ANGELO Framework was effectively used to develop community-participatory action plans for obesity prevention in children and adolescents across diverse cultural settings in Australia, New Zealand, Fiji, and Tonga, involving over 120 identified elements for prioritization.

Engaging youth in the planning process fostered a sense of ownership and allowed for the incorporation of their specific needs, demonstrating that community involvement is crucial for creating effective and culturally relevant obesity prevention strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Creating community action plans for obesity prevention using the ANGELO (Analysis Grid for Elements Linked to Obesity) Framework. Simmons, A., Mavoa, HM., Bell, AC., et al.[2023]

The Center TRT developed a systematic approach to enhance public health practitioners' competencies in obesity prevention through 7 annual courses, which were well-received by participants (n = 243) for their quality and relevance.

Post-course evaluations showed that over 70% of participants felt confident in their abilities to perform key competencies, and at a 6-month follow-up, most reported completing at least one action plan activity, indicating the training's lasting impact on their practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic approach to evaluating public health training: the obesity prevention in public health course. Mainor, A., Leeman, J., Sommers, J., et al.[2019]

References

1. England pubmed.ncbi.nlm.nih.gov

A quasi-experimental study to mobilize rural low-income communities to assess and improve the ecological environment to prevent childhood obesity. [2018]

2. India pubmed.ncbi.nlm.nih.gov

The effectiveness of self-empowerment-based patient-centered care for obese students in primary services: A randomized controlled trial. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Competency Based Approach to Community Health (COACH): The methods of a family-centered, community-based, individually adaptive obesity randomized trial for pre-school child-parent pairs. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

A Community Resource Map to Support Clinical-Community Linkages in a Randomized Controlled Trial of Childhood Obesity, Eastern Massachusetts, 2014-2016. [2019]

5. England pubmed.ncbi.nlm.nih.gov

A challenging balancing act to engage children and their families in a healthy lifestyle - Nurses' experiences of child-centred health dialogue in child health services in Sweden. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Competency-Based Approaches to Community Health: A Randomized Controlled Trial to Reduce Childhood Obesity among Latino Preschool-Aged Children. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

One-Year Mixed-Methods Case Study of a Community-Academic Advisory Board Addressing Childhood Obesity. [2020]

8. England pubmed.ncbi.nlm.nih.gov

Creating community action plans for obesity prevention using the ANGELO (Analysis Grid for Elements Linked to Obesity) Framework. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

A systematic approach to evaluating public health training: the obesity prevention in public health course. [2019]