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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial seeks effective methods to prevent childhood obesity, particularly in low-income Hispanic/Latino families, by developing tailored programs involving children, parents, and the community. It compares a health curriculum called COACH (Collaboration Oriented Approach to Controlling High Blood Pressure), which includes activities for kids, family support, and community programs, with an educational program focused on school readiness and language skills. Families who speak Spanish at home and have children aged 4-6 meeting specific body type criteria are encouraged to participate. Participants should commit to a two-year study and have access to a mobile phone. As an unphased trial, this study offers families a unique chance to contribute to innovative solutions for preventing childhood obesity.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the COACH program has been tested in other areas, particularly for controlling high blood pressure. Although specific data on its safety for childhood obesity is lacking, studies with different groups have not identified major safety issues. The program includes lessons and community activities, which generally pose low risk.

Specific safety studies for the School Readiness Program, used as a comparison, are not available. However, since it focuses on education and language skills, it likely carries minimal safety risks.

Overall, programs like COACH and School Readiness, which emphasize education and lifestyle changes, usually maintain a good safety record. They aim to encourage healthy habits rather than using medications, often resulting in fewer side effects. Always consult the trial team for the most relevant safety information for your situation. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the COACH intervention because it takes a multi-level approach to tackling childhood obesity, unlike many current treatments that focus solely on diet or exercise. COACH combines a health curriculum tailored for young children with a family-based approach that encourages parent-child interactions to promote healthy behaviors, and it also includes community support through local Parks and Rec centers. This comprehensive strategy not only aims to improve individual health but also enhances community resources, making it a potentially powerful tool in preventing and managing childhood obesity.

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

Research has shown that the COACH program, one of the interventions in this trial, can help reduce obesity across various groups. Studies have found it effective in aiding adults in weight loss through Co-Active coaching, which supports individuals in setting and achieving health goals. The COACH program has also successfully managed blood pressure, indicating improvements in overall health habits. By involving family and community, it aims to create a supportive environment for healthy changes. This approach is specifically designed to help families with young children develop healthier habits together. Meanwhile, the Educational Control arm in this trial focuses on a school readiness intervention to enhance children's language and storytelling skills, ultimately aiding school readiness. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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 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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38977368/

Collaboration Oriented Approach to Controlling High blood ... This study aims to measure the effectiveness of the COACH intervention and evaluate its adoption as part of BP management.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11256044/

Collaboration Oriented Approach to Controlling High blood ... This study aims to measure the effectiveness of the COACH intervention and evaluate its adoption as part of BP management.

3. digital.ahrq.gov digital.ahrq.gov/ahrq-funded-projects/collaboration-oriented-approach-controlling-high-blood-pressure-coach

Collaboration-Oriented Approach to Controlling High Blood ... A mixed methods study with a randomized clinical trial will use social cognitive theory to engage patients and evaluate COACH's effectiveness at lowering BP.

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2800943

Effect of a Telephone Health Coaching Intervention on ... A telephone coaching and blood pressure self-monitoring intervention effective in reducing blood pressure compared with usual care among young adults with ...

5. bmcpublichealth.biomedcentral.com bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-019-6640-5

Coaching and/or education intervention for parents with ... Co-Active coaching has been evaluated as an effective short- and long-term obesity reduction approach in adult populations, and shown positive ...

6. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/fullarticle/2816426

Practice Facilitation and Peer Coaching for Uncontrolled ... In this cluster randomized clinical trial of 69 practices with 1209 participants, neither peer coaching nor practice facilitation improved blood pressure ...

7. ohsu.elsevierpure.com ohsu.elsevierpure.com/en/publications/study-protocol-collaboration-oriented-approach-to-controlling-hig

Collaboration Oriented Approach to Controlling High blood ... This study aims to measure the effectiveness of the COACH intervention and evaluate its adoption as part of BP management. Methods and analysis ...