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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to make effective obesity treatments more accessible to children in underserved communities. The study tests a program called Competency Based Approaches to Community Health (COACH), which encourages kids, their families, and their communities to collaborate on healthy habits. The trial has two parts: one tests the standard COACH program, and the other adapts it for local community needs. Children aged 6 to 11 with obesity who live near certain community centers in Middle Tennessee and have a parent willing to participate for six months may be a good fit. This trial could help more families access obesity care and foster healthier communities.

As an unphased trial, this study offers a unique opportunity for families to contribute to research that could enhance obesity care in their communities.

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 prior data suggests that the COACH intervention is safe for children?

Research has shown that the COACH program helps children and their families develop healthier habits to address obesity. This program includes activities for kids, advice for parents, and uses local community centers to support families.

The available information does not report specific side effects or problems. Since the study focuses on behavior changes rather than testing a new drug or medical procedure, it is generally expected to be safe. Participants engage in lessons and physical activities that are easy to moderate in intensity, which are usually comfortable for both children and parents.

Participants should always communicate openly with the study team about any concerns or health issues that arise during the program. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the COACH program for childhood obesity because it takes a multi-level approach, targeting individuals, families, and communities. Unlike standard treatments that often focus solely on individual behavior change or medication, COACH involves parents and community centers, making it a comprehensive strategy. This program is unique because it customizes interventions for each community, encouraging local adaptation and ownership, which can lead to more sustainable lifestyle changes. Additionally, the inclusion of an online platform allows for flexible, self-paced learning, making it accessible for busy families.

What evidence suggests that this trial's treatments could be effective for childhood obesity?

Research has shown that the Competency Based Approaches to Community Health (COACH) program can help reduce childhood obesity. In this trial, participants will join either the COACH Intervention arm or the Adaptation arm. Studies have found that COACH improves children's body mass index (BMI, which measures body fat based on height and weight) over a year. Parents in the program also see positive changes in their BMI. The program teaches children healthy habits and involves families in making these changes. Community centers deliver the program, making it accessible to more families. These findings suggest that COACH could effectively address childhood obesity, especially in communities that need it most. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

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

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

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

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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 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]

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]

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]

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 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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03141151

Competency-based Approaches to Community Health The primary outcome of interest will be early childhood BMI trajectory over 1 year. Additional measures will include survey data to measure parent and child ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714418303604

Competency Based Approach to Community Health ... COACH is a randomized controlled trial of a family-centered, community-based, and individually-tailored behavioral intervention for childhood obesity among ...

3. liebertpub.com liebertpub.com/doi/full/10.1089/chi.2019.0064

Competency-Based Approaches to Community Health The purpose of this study is to test the effectiveness of a novel intervention, Competency-Based Approaches to Community Health (COACH), on changes in child BMI ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30144630/

Competency Based Approach to Community Health (COACH) The primary outcome of the trial is child body mass index trajectory over 1 year. Secondary outcomes include parent body mass index change, child waist ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6310120/

Competency Based Approach to Community Health (COACH) The primary outcome of the trial is child body mass index trajectory over 1 year. Secondary outcomes include parent body mass index change, ...

6. researchgate.net researchgate.net/publication/334983940_Competency-Based_Approaches_to_Community_Health_A_Randomized_Controlled_Trial_to_Reduce_Childhood_Obesity_among_Latino_Preschool-Aged_Children

(PDF) Competency-Based Approaches to Community Health External datasets will include the Competency-Based Approaches to Community Health (COACH) study, the National Survey of Children's Health (NSCH), and the Child ...