Addressing Social Determinants of Health in Child Obesity Treatment Using Community Health Workers
NCT Number: NCT06520657
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Child Obesity|Social Determinants of Health
Interventions: OTHER: Community Health Worker|BEHAVIORAL: Child weight management intervention|OTHER: Standard of Care referral to resources
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)
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-10-01
Completion Date: 2027-01-01

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)

Primary Outcome Measures: 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 Outcome Measures: 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|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|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