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

Addressing Social Determinants of Health in Child Obesity Treatment Using Community Health Workers: the Role of Parental Bandwidth in Treatment Effectiveness

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)

Study Overview

• Status: Active, not recruiting
• Conditions: Child Obesity; Social Determinants of Health
• Intervention / Treatment: Other: Community Health Worker; Behavioral: Child weight management intervention; Other: Standard of Care referral to resources

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Kansas City, Missouri, United States, 64108
      • Children's Mercy Kansas City

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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.; Behavioral: Child weight management intervention; This is a 12-week family-based behavioral group intervention to address childhood overweight and obesity.; Other: 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.
Active Comparator: 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.	Behavioral: Child weight management intervention; This is a 12-week family-based behavioral group intervention to address childhood overweight and obesity.; Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Enrollment Rate	Number of participants enrolled (consented) per month	1 year
Retention	Attendance at 6 month data assessment	6 months
Satisfaction with Community Health Worker (CHW)	A 15-item scale asks about quality of interactions and satisfaction with their CHW. Scores range from 15 to 60, with higher scores indicating increased satisfaction.	3 months
Satisfaction with PHIT Kids - Parent	A single 10-point Likert scale satisfaction rating about the group weight management intervention. Scores range from 1-10 with higher scores indicating increased satisfaction.	6 months
Inhibitory Control and Attention	The Flanker Inhibitory and Control Attention Test (Flanker) measures accuracy and reaction time to produce a combined score ranging from 0-10 with higher scores indicating better inhibitory control and attention.	3 months
Working Memory	The List Sorting Working Memory Test asks participants to recall a list of foods and animals in order from smallest to largest. Correct responses range from 0-26, and are then converted to nationally normed standard scores ranging from 59-140, with higher scores indicating better working memory.	3 months
Cognitive Flexibility	The Dimensional Change Card Sort Test (DCCS) measures accuracy and reaction time to produce a combined score ranging from 0-10 with higher scores indicating better cognitive flexibility.	3 months
Parent Cognitive Capacity	The Raven's 2 Progressive Matrices- Digital Short Form (Raven's 2) tests fluid intelligence by asking participants to identify missing pieces in visual geometric patterns of up to 24 progressively more difficult trials. The total number correct is converted into Standard Scores, which will be compared to a participant's other scores over the course of the study. Standard scores range from 59-140 with higher scores indicating increased cognitive capacity.	3 months
Child Body Mass Index (BMI) Z-Score	6 months	Change in BMI Z-score over a 6 month time period in the child with obesity or overweight

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PHIT Kids attendance	percent of PHIT Kids sessions attended	6 months
Percentage of needs met or partially met	At 3 months, participants will review each need identified at baseline and report if they received "All the help I needed," "Most of the help I needed," "A little of the help I needed," or "None of the help I needed." The total number of needs that were at least partially met ("a little", "most" or "all") or that were fully met ("all") will be divided by the total number of needs at baseline	3 months
Enrollment in at least one new resource	Yes/No. Family has accessed at 3 months at least one new community or government resource since baseline. Participants will review a list of resources potentially offered to CHW clients and respond whether they currently receive this resource at baseline and 3 months	3 months
Number of key measures completed	Number of the following measures completed - outcome measures (child BMI-z, parent weight, MVPA (actigraph; at least 4 days), dietary measures (3 recalls)), bandwidth measures (executive functions measures and Raven matrices) and self-efficacy.	6 months
Parent Weight	Change in parent weight at 6 month and 12 months	6 months and 12 months
Self-Efficacy	10-item, 5-point Likert scale. Measured by the General Self-Efficacy Scale in the NIH Toolbox. This scale assesses an individual's perceived ability to cope with stressful situations. Scores range from 10 to 50 with higher scores indicating higher self-efficacy.	6 months
Child Moderate to Vigorous Physical Activity (MVPA)	Minutes per week in moderate to vigourous physical activity as measure by an Actigraph waist accelerometer worn by the child. Also percent of time in MVPA	6 months and 12 months
Child Dietary Intake	Three 24 hour recalls completed by parent using the he Automated Self-Administered 24-hour Dietary Assessment Tool (ASA 24) computer program - used to calculate fruit and vegetable (FV) servings, sugar sweetened beverages, and number of high fat/high sugar foods (foods with >7g of fat and/or 12g of sugar)	6 months and 12 months

Collaborators and Investigators

• Sponsor: Children's Mercy Hospital Kansas City
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); University of Kansas Medical Center; Community Health Council of Wyandotte County
• Investigators: Principal Investigator: Helena Laroche, MD, Children's Mercy Kansas City

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: July 2, 2024
• First Submitted That Met QC Criteria: July 23, 2024
• First Posted (Actual): July 25, 2024

Study Record Updates

• Last Update Posted (Actual): January 26, 2026
• Last Update Submitted That Met QC Criteria: January 22, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Randomized trial; Executive function; Community Health Workers; Pilot Study; Child Obesity Treatment
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Obesity; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Pediatric Obesity; Health Care Facilities Workforce and Services; Health Personnel; Allied Health Personnel; Community Health Workers
• Other Study ID Numbers: STUDY00002819; 1R01DK139363-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No