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

120 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Community Health Worker for childhood obesity?

Research shows that community health workers can help reduce childhood obesity, especially in underserved communities. A review found that these workers had a small but significant impact on reducing children's body mass index (BMI), which is a measure of body fat based on height and weight. ^{1 2 3 4 5}

Is it safe to use community health workers for childhood obesity interventions?

Community health workers have been involved in various childhood obesity programs, and there is no indication of safety concerns in the studies reviewed. They are trusted members of the community and help provide culturally appropriate health education. ^{1 2 3 4 5}

How is the Community Health Worker treatment for childhood obesity different from other treatments?

The Community Health Worker treatment is unique because it involves trusted community members who provide personalized support and education to families, focusing on culturally appropriate nutrition and lifestyle changes, especially in underserved communities. This approach is different from standard medical treatments as it emphasizes community involvement and health equity. ^{1 3 4 5 6}

What is the purpose of this trial?

The goal of this small pilot study is to test the feasibility of combining a three-month intervention of working with a community health worker (CHW) to address social risk factors for patients prior to beginning a group weight management program for childhood obesity -- Promoting Health in Teens and Kids (PHIT Kids)

Research Team

Helena Laroche, MD

Principal Investigator

Children's Mercy Kansas City

Eligibility Criteria

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 between 8 and 12 years old.

Exclusion Criteria

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

My child is on medication that causes weight gain.

My child's medication and weight have been stable for the last 3 months.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

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

Results From La Vida Buena (The Good Life): A Quasi-Experimental Intervention of a Community Health Worker-Led Family-Based Childhood Obesity Program for Latino Children 5-8 Years of Age on the U.S.-Mexico Border. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Addressing asthma and obesity in children with community health workers: proof-of-concept intervention development. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Design and methods of the Healthy Kids & Families study: a parent-focused community health worker-delivered childhood obesity prevention intervention. [2022]

4. England pubmed.ncbi.nlm.nih.gov

The role and impact of community health workers in childhood obesity interventions: a systematic review and meta-analysis. [2023]

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

Influences of Parenting Education on Development of Obesity Among Young Children. [2023]

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

Community Health Workers in Schools: A Systematic Review. [2023]