Clinical trial NCT03195790: Creating Healthy Environments for Chicago Kids
Official title: Value and Mechanisms of Home Visitation in Obesity Interventions for Low-income Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Obesity
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2017-06-22
Enrollment: 269
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

Brief summary: Pediatric obesity interventions for low-income populations are increasingly delivered in children's homes, which may make treatment more accessible to families and enhance the potency of the intervention in several ways. This randomized trial will directly test whether delivering family-based behavioral interventions for pediatric overweight/obesity in the home setting improves weight loss outcomes in low-income children relative to medical center-based treatment. The trial will also quantify the cost-effectiveness of home visitation, and explore the mechanisms accounting for observed treatment effects

Detailed description: The goal of this project is to systematically evaluate the incremental weight loss benefit and cost-effectiveness of delivering standard family-based treatment for pediatric overweight/obesity in the home setting vs. traditional medical settings. In a randomized controlled trial involving low-income households, 266 children ages 6-12 years will be allocated to 12 months of family-based treatment delivered either in their home or at an urban academic medical center. Both arms will receive the same intervention content and dosage, and differ only in the location of in-person treatment sessions. Aim 1 is to test the hypothesis that home-based treatment produces a greater reduction in child adiposity, reflected in 12-month change in BMI z-score. Aim 2 is to compare the cost-effectiveness of home-based treatment to medical center-based treatment, and calculate the added cost of the incremental weight loss benefit associated with home visitation. These data will inform efforts to disseminate home-based interventions for low-income populations by public health agencies and third-party payers. Aim 3 is to explore specific mechanisms through which home visitation may improve weight loss outcomes.

Eligibility criteria: Inclusion Criteria:

* Family includes at least one child who is 6 to 12 years old, and is overweight or obese (has a body mass index at or above the 85th percentile for age and sex)
* Child's household has an income-to-poverty ratio ≤ 2.0

Exclusion Criteria:

* Child or caregiver(s) are not fluent in English
* Unwilling to attend and complete either home-based or clinic-based treatment, or to complete any aspect of the study assessment battery
* Medical contraindication or barrier to weight loss treatment
* Caregiver has a major medical or psychiatric condition likely to interfere with treatment
* Plans to relocate outside the Chicago area in the next 12 months, or living in temporary or group housing with other families
* Resides more than 15 miles from the Illinois Medical District (study site)
* Conditions in or around the home that jeopardize staff/interventionist safety

Primary outcomes:
measure: Child adiposity
timeFrame: 12 months
Secondary outcomes:
measure: Clinically significant weight loss
timeFrame: 12 months
measure: Cost-effectiveness
timeFrame: 12 months
Other outcomes:
measure: Intervention dosage
timeFrame: 12 months
measure: Treatment recommendations
timeFrame: 12 months
measure: Change in the home food environment
timeFrame: 12 months
measure: Change in the home physical activity and media environment
timeFrame: 12 months
measure: Change in family routines
timeFrame: 12 months
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
References:
citation: Appelhans BM, French SA, Bradley LE, Lui K, Janssen I, Richardson D. CHECK: A randomized trial evaluating the efficacy and cost-effectiveness of home visitation in pediatric weight loss treatment. Contemp Clin Trials. 2020 Jan;88:105891. doi: 10.1016/j.cct.2019.105891. Epub 2019 Nov 15.