Clinical trial NCT06520657: Addressing Social Determinants of Health in Child Obesity Treatment Using Community Health Workers
Official title: Addressing Social Determinants of Health in Child Obesity Treatment Using Community Health Workers: the Role of Parental Bandwidth in Treatment Effectiveness
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Child Obesity
Social Determinants of Health
Keywords: Community Health Workers
Randomized trial
Pilot Study
Child Obesity Treatment
Executive function
Lead sponsor: Children's Mercy Hospital Kansas City
Sponsor class: OTHER
Collaborators: name: Community Health Council of Wyandotte County
name: University of Kansas Medical Center
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2024-07-25
Enrollment: 120
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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)


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

Primary outcomes:
measure: Enrollment Rate
timeFrame: 1 year
measure: Retention
timeFrame: 6 months
measure: Satisfaction with Community Health Worker (CHW)
timeFrame: 3 months
measure: Satisfaction with PHIT Kids - Parent
timeFrame: 6 months
measure: Child Body Mass Index (BMI) Z-Score
timeFrame: Change in BMI Z-score over a 6 month time period in the child with obesity or overweight
measure: Inhibitory Control and Attention
timeFrame: 3 months
measure: Working Memory
timeFrame: 3 months
measure: Cognitive Flexibility
timeFrame: 3 months
measure: Parent Cognitive Capacity
timeFrame: 3 months
Secondary outcomes:
measure: PHIT Kids attendance
timeFrame: 6 months
measure: Percentage of needs met or partially met
timeFrame: 3 months
measure: Enrollment in at least one new resource
timeFrame: 3 months
measure: Number of key measures completed
timeFrame: 6 months
measure: Parent Weight
timeFrame: 6 months and 12 months
measure: Child Moderate to Vigorous Physical Activity (MVPA)
timeFrame: 6 months and 12 months
measure: Child Dietary Intake
timeFrame: 6 months and 12 months
measure: Self-Efficacy
timeFrame: 6 months
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Children's Mercy Kansas City
state: Missouri
Study officials:
affiliation: Children's Mercy Kansas City
name: Helena Laroche, MD
role: PRINCIPAL_INVESTIGATOR
References: