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

NCT06520657 | Active Not Recruiting DMC

• 2 other identifiers: STUDY000028191R01DK139363-01
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Keywords

Community Health Workers; Randomized trial; Pilot Study; Child Obesity Treatment; Executive function

Outcome Measures

Primary Outcomes (9)

• 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

• 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

• 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

Secondary Outcomes (8)

• PHIT Kids attendance

  6 months

• Percentage of needs met or partially met

  3 months

• Enrollment in at least one new resource

  3 months

• Number of key measures completed

  6 months

• Parent Weight

  6 months and 12 months

Study Arms (2)

CHW plus child weight management intervention

EXPERIMENTAL

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; Behavioral: Child weight management intervention; Other: Standard of Care referral to resources

Child weight management intervention only

ACTIVE COMPARATOR

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; Other: Standard of Care referral to resources

Interventions

Community Health Worker 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.

CHW plus child weight management intervention

Child weight management intervention BEHAVIORAL

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

CHW plus child weight management intervention; Child weight management intervention only

Standard of Care referral to resources 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.

CHW plus child weight management intervention; Child weight management intervention only

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• Community Health Council of Wyandotte County: collaborator
• University of Kansas Medical Center: collaborator
• Children's Mercy Hospital Kansas City: lead

Study Sites (1)

Children's Mercy Kansas City

Kansas City, Missouri, 64108, United States

Location

MeSH Terms

Conditions

Pediatric Obesity

Interventions

Community Health Workers

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Allied Health Personnel; Health Personnel; Health Care Facilities Workforce and Services

Study Officials

• Helena Laroche, MD

  Children's Mercy Kansas City

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician, MD

Model Details: 60 Families (2 participants in each- parent and child) will be randomized to community health worker intervention or standard social risk factor (SRF) referral for the first 3 months and then 3-6 months both groups will do the same child obesity intervention then 6-12 months both will receive no intervention.

Study Record Dates

• First Submitted: July 2, 2024
• First Posted: July 25, 2024
• Study Start: January 3, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: January 26, 2026

Record last verified: 2026-01

Locations

US (1)