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

Children's Mercy Hospital Kansas City

Status: Active, not recruiting

Conditions: Social Determinants of Health; Child Obesity

Treatments: Other: Community Health Worker; Other: Standard of Care referral to resources; Behavioral: Child weight management intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06520657

1R01DK139363-01 (U.S. NIH Grant/Contract)

STUDY00002819

Details and patient eligibility

About

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)

Enrollment: 120 estimated patients

Sex: All

Ages: 8+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

CHW plus child weight management intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Child weight management intervention

Other: Standard of Care referral to resources

Other: Community Health Worker

Child weight management intervention only

Active Comparator group

Description:

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.

Treatment:

Behavioral: Child weight management intervention

Other: Standard of Care referral to resources