Addressing Social Determinants of Health in Child Obesity Treatment Using Community Health Workers

NCT ID: NCT06520657

Last Updated: 2026-01-09

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-03
• Study Completion Date: 2027-01-01

Brief Summary

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)

Conditions

Child Obesity; Social Determinants of Health

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CHW plus child weight management intervention

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 Type: EXPERIMENTAL

Community Health Worker

Intervention Type: OTHER

Participants are screened for social determinants of health and work with a community health worker for three months to connect them with community and government services to address their family's needs.

Child weight management intervention

Intervention Type: BEHAVIORAL

This is a 12-week family-based behavioral group intervention to address childhood overweight and obesity.

Standard of Care referral to resources

Intervention Type: OTHER

One-time referral to resources based on need that families can access independently either by providing electronic referral to or providing written contact information for a community resource.

Child weight management intervention only

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.

Group Type: ACTIVE_COMPARATOR

Child weight management intervention

Intervention Type: BEHAVIORAL

This is a 12-week family-based behavioral group intervention to address childhood overweight and obesity.

Standard of Care referral to resources

Intervention Type: OTHER

One-time referral to resources based on need that families can access independently either by providing electronic referral to or providing written contact information for a community resource.

Interventions

Community Health Worker

Participants are screened for social determinants of health and work with a community health worker for three months to connect them with community and government services to address their family's needs.

Intervention Type: OTHER

Child weight management intervention

This is a 12-week family-based behavioral group intervention to address childhood overweight and obesity.

Intervention Type: BEHAVIORAL

Standard of Care referral to resources

One-time referral to resources based on need that families can access independently either by providing electronic referral to or providing written contact information for a community resource.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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
• Child aged 8 through 12 years of age
• Child with BMI% at 85th percentile or higher and less than the 120% of the 95th percentile (overweight or class 1 obesity)
• Child must live with parent/guardian at least 5 out of the 7 days on average (70% of the time)
• Child and parent able to speak English

Exclusion Criteria

• Child on medications known to cause ongoing weight gain (e.g., atypical anti-psychotics, chronic prednisone, insulin)
• Child on other medications know to affect weight if dose and BMI z-score has not been stable for 3 months.
• Diabetes or other disease that has a significant effect on diet, physical activity, or ability to take part in trial activities besides obesity (does not included treated or mild depression or anxiety, limited food allergies or mild physical activity limitations)
• For parents: new MI, stroke or cancer diagnosis (excluding localized skin cancers) in past 6 months, history of bariatric surgery within the past 3 years, pregnancy in last 6 months or planned within 1 year
• Child or parent has significant developmental or cognitive impairments or other significant medical issue that would interfere with ability to participate or complete assessment
• Parent or child has significant physical limitation
• Parent/child planning to move to from Children's Mercy Kansas City (CMKC) service area

• Minimum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Community Health Council of Wyandotte County

UNKNOWN

Sponsor Role: collaborator

University of Kansas Medical Center

OTHER

Sponsor Role: collaborator

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

NIH

Sponsor Role: collaborator

Children's Mercy Hospital Kansas City

OTHER

Sponsor Role: lead

Responsible Party

Helena Laroche, MD

Physician, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Helena Laroche, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Mercy Kansas City

Locations

Children's Mercy Kansas City

Kansas City, Missouri, United States

Countries

United States

Other Identifiers

1R01DK139363-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00002819

Identifier Type: -

Identifier Source: org_study_id