Community Health Worker Support for Childhood Obesity

Overseen By Pete Muenks, MA

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Children's Mercy Hospital Kansas City

Must not be taking: Atypical antipsychotics, Prednisone, Insulin

Disqualifiers: Diabetes, Significant cognitive impairments, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if working with a community health worker (CHW) can address social challenges affecting weight management in children before they begin a group weight-loss program. The study compares two groups: one receives support from a CHW to address social issues, while the other gets a one-time referral to community resources. It targets children aged 8–12 who are overweight or have mild obesity and face significant social challenges, such as housing instability or food insecurity. As an unphased trial, this study provides a unique opportunity to explore innovative support strategies for children facing social challenges.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but children on medications that cause weight gain or affect weight must have stable doses and BMI for 3 months to participate.

What prior data suggests that working with a community health worker is safe for addressing social risk factors in childhood obesity?

Research shows that community health workers (CHWs) are safe and effective in supporting health programs, such as those targeting childhood obesity. In past studies, CHWs worked in homes, clinics, and schools to manage and reduce obesity in children. No major problems have been directly linked to CHW involvement. These studies suggest that CHWs are well-received and can play an important role in addressing social factors contributing to obesity. Therefore, including community health workers in this program appears to be a safe choice for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Community Health Worker (CHW) approach for addressing childhood obesity because it offers a unique focus on social determinants of health, which are often overlooked in traditional treatments. Unlike standard care, which typically involves one-time referrals to community resources, the CHW model provides ongoing, personalized support over three months to tackle social risk factors before starting weight management programs. This proactive, hands-on approach aims to create a more supportive environment for long-term health changes, potentially leading to more sustainable weight management outcomes for children.

What evidence suggests that the Community Health Worker intervention is effective for childhood obesity?

Research has shown that community health workers (CHWs) can effectively help children manage their weight. In this trial, participants in one arm will work with CHWs for three months to address social risk factors before starting a child weight management group treatment. One study found that children working with CHWs experienced a decrease in their Body Mass Index (BMI) by about 0.23 units each year. Another study reported a similar BMI reduction of 0.26 units, indicating consistent benefits. CHWs assist by addressing social factors that affect health, which significantly impacts managing childhood obesity. These findings suggest that using CHWs could be a promising way to help kids reach healthier weights. ^{1 3 6 7 8}

Who Is on the Research Team?

Helena Laroche, MD

Principal Investigator

Children's Mercy Kansas City

Are You a Good Fit for This Trial?

This trial is for children aged 8-12 with a BMI at or above the 85th percentile but below the 120% of the 95th percentile, indicating overweight or class 1 obesity. They must live with a guardian most of the week and speak English. Families should have at least one major social risk factor as identified by PRAPARE.

Inclusion Criteria

My child lives with me most of the week.

Family must have one major social risk factor on the Protocol for Responding to & Assessing Patients' Assets, Risks & Experiences (PRAPARE) of the 14 modifiable risk factors

My child is overweight or has class 1 obesity according to their BMI percentile.

Exclusion Criteria

I do not have any health conditions affecting my diet or physical activity except for obesity.

Parent/child planning to move to from Children's Mercy Kansas City (CMKC) service area

My child is on medication that causes weight gain.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention with Community Health Worker

Participants work with a community health worker for three months to address social risk factors before starting the weight management program

3 months

Regular visits with community health worker

Child Weight Management Program

Participants begin the child weight management group treatment

3 months

Group sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Community Health Worker

Trial Overview The study tests if working with community health workers to tackle social challenges can help before starting PHIT Kids, a group program for managing child weight. It's a small pilot study to see if this approach is practical.

How Is the Trial Designed?

Group I: CHW plus child weight management intervention Experimental Treatment 3 Interventions

Participants in this arm will work with a community health worker for three months to address social risk factors (negative social determinants of health) prior to beginning a child weight management group treatment.

Group II: Child weight management intervention only Active Control 2 Interventions

Participants in this arm will receive the standard of care which includes a one-time referral to community resources to meet their social needs. At three months they also begin the same child weight management group treatment as the experimental group.

Community Health Worker is already approved in United States for the following indications:

Approved in United States as Community Health Worker for:

• Support for diabetes technology use in type 1 diabetes

Who Is Running the Clinical Trial?

Children's Mercy Hospital Kansas City

Lead Sponsor

Trials

261

Recruited

941,000+

University of Kansas Medical Center

Collaborator

Trials

527

Recruited

181,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Community Health Council of Wyandotte County

Collaborator

Trials

1

Recruited

120+

Published Research Related to This Trial

A randomized controlled trial involving 177 high-risk infants showed that an educational intervention by community health workers did not significantly prevent obesity by age 3, with 24% of children classified as obese at the final visit.

However, breastfed infants in the intervention group experienced significantly less time spent obese (11.9%) compared to formula-fed infants in the control group (29.8%), highlighting the importance of breastfeeding in obesity prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influences of Parenting Education on Development of Obesity Among Young Children. McCormick, DP., Niebuhr, B., Reyna, L., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6329372/

The role and impact of community health workers in ... The purpose of this systematic review and meta-analysis was to explore the role and effectiveness of community health workers in childhood obesity ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S221133552200393X

Outcomes of a 24-month childhood obesity prevention ... This study tested the effectiveness of Healthy Kids & Families, a theory-driven, low-intensity, parent-focused community health worker (CHW)-delivered obesity ...

3. publications.aap.org publications.aap.org/pediatrics/article/148/4/e2021050405/181291/Comparative-Effectiveness-of-Clinical-and

Comparative Effectiveness of Clinical and Community ... Compared with the comparison sites, per year, children in the HWC had a −0.23 (95% CI: −0.36 to −0.10) decrease in BMI and a −1.03 (95% CI −1.61 ...

4. link.springer.com link.springer.com/article/10.1007/s40615-025-02420-x

Two-Year Outcomes for the Active and Healthy Families ... Our study aims to assess the 2-year outcomes and explore the potential mechanisms of behavior change, along with the barriers to sustaining those behaviors.

5. liebertpub.com liebertpub.com/doi/10.1177/21532176251386213?doi=10.1177/21532176251386213

Implementation and Effectiveness of the Healthy Weight ... Results: The packaged HWC reached 191 children. The HWC was effective in reducing BMI −0.26 (95% confidence interval [CI]: −0.47, −0.04), ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2211335522003783

From childhood obesity risk to healthy growth in the U.S. Disparities in childhood obesity risk continue to rise in marginalized communities. · Medical and public health obesity prevention models have been ineffective.

7. researchgate.net researchgate.net/publication/366068116_The_Healthy_Kids_Families_Study_Outcomes_of_a_24-Month_Childhood_Obesity_Prevention_Intervention

The Healthy Kids & Families Study: Outcomes of a 24- ... There was no significant change in parent outcomes. The Healthy Kids & Families intervention shows promise for obesity prevention among children ...

8. ahrq.gov ahrq.gov/downloads/pub/evidence/pdf/comhealthwork/comhwork.pdf

Outcomes of Community Health Worker Interventions To conduct a systematic review of the evidence on characteristics of community health workers (CHWs) and CHW interventions, outcomes of such interventions, ...