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Active, not recruitingNCT06520657Updated Sep 9, 2026

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

An interventional study of Community Health Worker and Child weight management intervention in Child Obesity and Social Determinants of Health, sponsored by Children's Mercy Hospital Kansas City. Active, not recruiting at 1 site in United States. Open to participants aged 8 Years and older. Per ClinicalTrials.gov, last updated 2026-09-09.

Sponsored by Children's Mercy Hospital Kansas City · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
8 Years and older
Sex
All
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Study 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)

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Conditions studied

  • Child Obesity
  • Social Determinants of Health

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Keywords

  • Community Health Workers
  • Randomized trial
  • Pilot Study
  • Child Obesity Treatment
  • Executive function
03

In context

Pediatric Obesity

1,117 studies on the registry are indexed under Pediatric Obesity; 189 are open to participants now.

This study's planned enrollment of 120 is above the median of 103 across 862 interventional studies indexed under Pediatric Obesity.

Browse Pediatric Obesity studies →

Lead sponsor

Children's Mercy Hospital Kansas City is the lead sponsor of 209 studies on the registry; 22 are open to participants now.

Of its 18 completed or terminated interventional studies of FDA-regulated products, 14 (78%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
8 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
120 participants (estimated)

Study arms

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

  • 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 · Other: Standard of Care referral to resources

Interventions

  • OtherCommunity 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.

  • BehavioralChild weight management intervention

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

  • OtherStandard 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.

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What researchers measure

Primary outcomes

  1. Enrollment Rate

    Number of participants enrolled (consented) per month

    Time frame: 1 year

  2. Retention

    Attendance at 6 month data assessment

    Time frame: 6 months

  3. 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.

    Time frame: 3 months

  4. 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.

    Time frame: 6 months

  5. Child Body Mass Index (BMI) Z-Score

    6 months

    Time frame: Change in BMI Z-score over a 6 month time period in the child with obesity or overweight

  6. 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.

    Time frame: 3 months

  7. 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.

    Time frame: 3 months

  8. 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.

    Time frame: 3 months

  9. 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.

    Time frame: 3 months

Secondary outcomes

  1. PHIT Kids attendance

    percent of PHIT Kids sessions attended

    Time frame: 6 months

  2. 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

    Time frame: 3 months

  3. 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

    Time frame: 3 months

  4. 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.

    Time frame: 6 months

  5. Parent Weight

    Change in parent weight at 6 month and 12 months

    Time frame: 6 months and 12 months

  6. 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

    Time frame: 6 months and 12 months

  7. 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)

    Time frame: 6 months and 12 months

  8. 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.

    Time frame: 6 months

07

Study locations

1 site
  • Children's Mercy Kansas City
    Kansas City, Missouri 64108, United States
08

References and documents

Study documents

  • Informed consent form · Jan 20, 2026

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06520657
Lead sponsor
Children's Mercy Hospital Kansas City
Collaborators
Community Health Council of Wyandotte County, University of Kansas Medical Center, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Responsible party
Helena Laroche, MD (Physician, MD, Children's Mercy Hospital Kansas City) — Principal investigator
First posted
Jul 25, 2024
Start date
Jan 3, 2025
Primary completion
Jun 23, 2026
Completion
Jan 1, 2027 (estimated)
Last update
Sep 9, 2026

Study contacts

Helena Laroche, MD
principal investigator · Children's Mercy Kansas City

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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