Creating Healthy Environments for Chicago Kids (CHECK)

Value and Mechanisms of Home Visitation in Obesity Interventions for Low-income Children

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

Study Overview

• Status: Completed
• Conditions: Childhood Obesity
• Intervention / Treatment: Behavioral: Family-based pediatric obesity treatment

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 6-11 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.

• Study Type: Interventional
• Enrollment (Actual): 269
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 9 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Family includes at least one child who is 6 to 11 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 ≤ 1.85

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Medical center treatment arm; Family-based pediatric obesity treatment delivered at an urban medical center.	Behavioral: Family-based pediatric obesity treatment; Families with at least one overweight/obese child between ages 6 and 11 years will receive 12-months of family-based pediatric obesity treatment that emphasizes healthy changes to the home environment and family routines. The intervention targets dietary intake, physical activity, and consistent sleep.
Experimental: Home treatment arm; Family-based pediatric obesity treatment delivered in the family's home.	Behavioral: Family-based pediatric obesity treatment; Families with at least one overweight/obese child between ages 6 and 11 years will receive 12-months of family-based pediatric obesity treatment that emphasizes healthy changes to the home environment and family routines. The intervention targets dietary intake, physical activity, and consistent sleep.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Child adiposity	Change from baseline in child body mass index z-score (zBMI)	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinically significant weight loss	Proportion of children achieving adiposity reduction of at least 0.25 zBMI	12 months
Cost-effectiveness	Incremental cost-effectiveness ratio of home-based vs medical center treatment, calculated from societal perspective.	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intervention dosage	Dosage of intervention received in each arm, in units of clock time of intervention delivered	12 months
Treatment recommendations	Number of specific treatment recommendations provided to each family	12 months
Change in the home food environment	Number of obesity-promoting foods and beverages present in the home, measured by staff audits	12 months
Change in the home physical activity and media environment	Sports equipment and media devices in the home, measured by staff audits	12 months
Change in family routines	Family routines associated with childhood obesity risk, assessed through the Family Nutrition and Physical Activity Screening Tool	12 months

Collaborators and Investigators

• Sponsor: Rush University Medical Center
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 8, 2017
• Primary Completion (Actual): September 19, 2022
• Study Completion (Actual): September 19, 2022

Study Registration Dates

• First Submitted: June 20, 2017
• First Submitted That Met QC Criteria: June 20, 2017
• First Posted (Actual): June 22, 2017

Study Record Updates

• Last Update Posted (Actual): October 31, 2022
• Last Update Submitted That Met QC Criteria: October 27, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Pediatric Obesity
• Other Study ID Numbers: 15120306; R01DK111358 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: This plan is to be determined.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No