Personalized Interventions for Childhood Obesity

(COACH Trial)

Overseen By LauraBeth Adams, RD, MBA

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Vanderbilt University Medical Center

Disqualifiers: Autism, Serious mental illness, others

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

Compensation: Varies

Number of Visits: Unknown

301 Participants Needed

Trial Summary

What is the purpose of this trial?

One-size-fits-all approaches have failed to demonstrate sustained effects on childhood obesity, especially among low-income minority families, who experience constantly changing barriers to engaging in health behavior. Addressing obesity in these populations requires intervening in early childhood and situating interventions in the context of families and communities. Developing personalized childhood obesity prevention interventions with sustained effectiveness that support families in health behaviors despite dynamic barriers could address chronic disease risk and health disparities in low-income and minority 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.

What data supports the effectiveness of the treatment COACH, Collaboration Oriented Approach to Controlling High Blood Pressure, COACH, School Readiness Intervention for childhood obesity?

Research shows that personalized care planning, which includes understanding personal barriers and strengths, can help patients make health improvements. Additionally, health coaching that offers customized support and links to community resources has been effective in managing pediatric obesity. ^{1 2 3 4 5}

Is the treatment for childhood obesity safe for humans?

The research articles provided do not contain specific safety data for the treatment of childhood obesity interventions mentioned, such as COACH or similar programs. ^{3 6 7 8 9}

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 program that tailors its approach to each child's specific needs, focusing on diet, physical activity, sleep, and parenting. It uses regular assessments and health coaches to provide personalized strategies, making it adaptable and supportive for sustainable health changes in children. ^{10 11 12 13 14}

Eligibility Criteria

This trial is for families with a parent/guardian at risk for obesity but not severely obese, and a child aged 4-7 years. They must be Hispanic/Latino, speak English or Spanish, have mobile phone access, and commit to a two-year study. Participants should live in specified Nashville zip codes if attending in person or any location for videoconferencing. Families must qualify as underserved by participating in certain assistance programs.

Inclusion Criteria

Considered underserved, measured by parent-self reporting eligibility for or participation in specific programs or services

My child's BMI is in the 5th percentile or higher for their age and gender.

I have regular access to a mobile phone.

Exclusion Criteria

Parents/legal guardians who do not meet the eligibility criteria

Children who do not meet the eligibility criteria

My child is below the 5th percentile in growth according to CDC charts.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Implementation of the COACH multi-level intervention targeting children, families, and communities to improve health behaviors and reduce obesity

24 months

Regular visits as per intervention schedule

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

Treatment Details

Interventions

• COACH
• School Readiness Intervention

Trial Overview The COACH program and School Readiness Intervention are being tested to prevent childhood obesity among low-income minority families. The interventions are personalized to help these families maintain healthy behaviors despite changing barriers.

Participant Groups

Group I: COACH Intervention Experimental Treatment 1 Intervention

COACH is a multi-level intervention, consisting of 1) developmentally appropriate health curriculum for 4-6 year old 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.

Group II: Educational Control Active Control 1 Intervention

The control arm will consist of a school readiness intervention developed by education and literacy experts on our team and implemented at local libraries. It will include 1) child lessons from Puente de Cuentos, a systematic, language-based curriculum focused on dual language storytelling (narrative language), and 2) parent sessions designed to improve parents' knowledge and skills related to improving children's language production and storytelling skills, to ultimately support school readiness.

COACH is already approved in United States for the following indications:

Approved in United States as COACH for:

• Hypertension management

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials

922

Recruited

939,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

University of North Carolina, Chapel Hill

Collaborator

Trials

1,588

Recruited

4,364,000+

Vanderbilt University

Collaborator

Trials

714

Recruited

6,143,000+

Findings from Research

The study identified eight key interpersonal processes during clinical consultations that help patients with obesity make meaningful health changes, including compassion, understanding root causes, and action planning.

By focusing on personalized care and fostering empathetic relationships, the approach led to improved patient activation and better physical and psychological health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Personalizing obesity assessment and care planning in primary care: patient experience and outcomes in everyday life and health. Luig, T., Anderson, R., Sharma, AM., et al.[2020]

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 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]

School-based interventions can lead to long-term positive health behavior changes in children, as they spend a significant amount of time in school, although their impact on weight measures is less clear due to common limitations.

Family-based interventions are effective in influencing children's behaviors, but issues like selection bias and high dropout rates can affect the reliability of their results; thus, a multidisciplinary approach that includes both school and family involvement is recommended for managing childhood obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Controlling childhood obesity: A systematic review on strategies and challenges. Kelishadi, R., Azizi-Soleiman, F.[2022]

The implementation optimisation intervention aimed at increasing parental enrolment and attendance in the HENRY obesity prevention programme did not show significant effectiveness, with similar enrolment rates (17.8% vs. 18.0%) and attendance rates (17.1% vs. 13.9%) between intervention and control groups.

External factors, such as national service restructuring and funding cuts, severely impacted the delivery of the HENRY programme, resulting in a significant reduction in the number of parents served, which may have influenced the trial outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A cluster RCT and process evaluation of an implementation optimisation intervention to promote parental engagement enrolment and attendance in a childhood obesity prevention programme: results of the Optimising Family Engagement in HENRY (OFTEN) trial. Bryant, M., Burton, W., Collinson, M., et al.[2021]

References

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

Personalizing obesity assessment and care planning in primary care: patient experience and outcomes in everyday life and health. [2020]

2. 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]

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

Translation of an Action Learning Collaborative Model Into a Community-Based Intervention to Promote Physical Activity and Healthy Eating. [2023]

4. Canada pubmed.ncbi.nlm.nih.gov

Patient-provider partnerships in healthcare: enhancing knowledge translation and improving outcomes. [2019]

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

Role of Health Coaches in Pediatric Weight Management. [2022]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Addressing Childhood Obesity Through Multisector Collaborations: Evaluation of a National Quality Improvement Effort. [2018]

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

Systems thinking in 49 communities related to healthy eating, active living, and childhood obesity. [2022]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Developing a Partnership for Change: The National Collaborative on Childhood Obesity Research. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Yours, mine, and ours: the importance of scientific collaboration in advancing the field of behavior change research. [2018]

10. England pubmed.ncbi.nlm.nih.gov

The effects of school-based lifestyle interventions on body mass index and blood pressure: a multivariate multilevel meta-analysis of randomized controlled trials. [2022]

11. 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]

12. England pubmed.ncbi.nlm.nih.gov

Multilevel analysis of the Be Active Eat Well intervention: environmental and behavioural influences on reductions in child obesity risk. [2022]

13. India pubmed.ncbi.nlm.nih.gov

Controlling childhood obesity: A systematic review on strategies and challenges. [2022]

14. England pubmed.ncbi.nlm.nih.gov

A cluster RCT and process evaluation of an implementation optimisation intervention to promote parental engagement enrolment and attendance in a childhood obesity prevention programme: results of the Optimising Family Engagement in HENRY (OFTEN) trial. [2021]