Clinical trial

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

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT06520657

Active, not recruitingNot applicableInterventional

What this study is about

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)

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age8 Years to Not listed

SexAll

Healthy volunteersNot accepted

ConditionChild Obesity, Social Determinants of Health

Full registry 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

Treatments and study arms

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.

Child weight management intervention

Behavioral

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

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.

Primary outcomes

Enrollment Rate1 year

Number of participants enrolled (consented) per month

Retention6 months

Attendance at 6 month data assessment

Satisfaction with Community Health Worker (CHW)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.

Satisfaction with PHIT Kids - Parent6 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-ScoreChange in BMI Z-score over a 6 month time period in the child with obesity or overweight

6 months

Inhibitory Control and Attention3 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.

Working Memory3 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.

Cognitive Flexibility3 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.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Children's Mercy Kansas City🇺🇸 Kansas City, Missouri, United States

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