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Clinical Trials/NCT06520657
NCT06520657
Active, Not Recruiting
N/A

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

Children's Mercy Hospital Kansas City1 site in 1 country120 target enrollmentJanuary 3, 2025

Overview

Phase
N/A
Intervention
Community Health Worker
Conditions
Child Obesity
Sponsor
Children's Mercy Hospital Kansas City
Enrollment
120
Locations
1
Primary Endpoint
Retention
Status
Active, Not Recruiting
Last Updated
3 months ago

Overview

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)

Registry
clinicaltrials.gov
Start Date
January 3, 2025
End Date
January 1, 2027
Last Updated
3 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Children's Mercy Hospital Kansas City
Responsible Party
Principal Investigator
Principal Investigator

Helena Laroche, MD

Physician, MD

Children's Mercy Hospital Kansas City

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

Arms & Interventions

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.

Intervention: Community Health Worker

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.

Intervention: Child weight management intervention

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.

Intervention: Standard of Care referral to resources

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.

Intervention: Child weight management intervention

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.

Intervention: Standard of Care referral to resources

Outcomes

Primary Outcomes

Retention

Time Frame: 6 months

Attendance at 6 month data assessment

Satisfaction with Community Health Worker (CHW)

Time Frame: 3 months

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.

Working Memory

Time Frame: 3 months

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.

Enrollment Rate

Time Frame: 1 year

Number of participants enrolled (consented) per month

Satisfaction with PHIT Kids - Parent

Time Frame: 6 months

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.

Child Body Mass Index (BMI) Z-Score

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

6 months

Inhibitory Control and Attention

Time Frame: 3 months

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.

Cognitive Flexibility

Time Frame: 3 months

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.

Parent Cognitive Capacity

Time Frame: 3 months

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.

Secondary Outcomes

  • 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)
  • Child Moderate to Vigorous Physical Activity (MVPA)(6 months and 12 months)
  • Child Dietary Intake(6 months and 12 months)
  • Self-Efficacy(6 months)

Study Sites (1)

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