Creating Healthy Environments for Chicago Kids (CHECK)
Primary Purpose
Childhood Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Family-based pediatric obesity treatment
Sponsored by
About this trial
This is an interventional treatment trial for Childhood Obesity
Eligibility Criteria
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
Sites / Locations
- Rush University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Medical center treatment arm
Home treatment arm
Arm Description
Family-based pediatric obesity treatment delivered at an urban medical center.
Family-based pediatric obesity treatment delivered in the family's home.
Outcomes
Primary Outcome Measures
Child adiposity
Change from baseline in child body mass index z-score (zBMI)
Secondary Outcome Measures
Clinically significant weight loss
Proportion of children achieving adiposity reduction of at least 0.25 zBMI
Cost-effectiveness
Incremental cost-effectiveness ratio of home-based vs medical center treatment, calculated from societal perspective.
Full Information
NCT ID
NCT03195790
First Posted
June 20, 2017
Last Updated
October 27, 2022
Sponsor
Rush University Medical Center
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1. Study Identification
Unique Protocol Identification Number
NCT03195790
Brief Title
Creating Healthy Environments for Chicago Kids
Acronym
CHECK
Official Title
Value and Mechanisms of Home Visitation in Obesity Interventions for Low-income Children
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
August 8, 2017 (Actual)
Primary Completion Date
September 19, 2022 (Actual)
Study Completion Date
September 19, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rush University Medical Center
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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 6-11 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial
Masking
InvestigatorOutcomes Assessor
Masking Description
Outcomes assessors, PI, and some co-investigators will be blinded to group assignment.
Allocation
Randomized
Enrollment
269 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Medical center treatment arm
Arm Type
Active Comparator
Arm Description
Family-based pediatric obesity treatment delivered at an urban medical center.
Arm Title
Home treatment arm
Arm Type
Experimental
Arm Description
Family-based pediatric obesity treatment delivered in the family's home.
Intervention Type
Behavioral
Intervention Name(s)
Family-based pediatric obesity treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Child adiposity
Description
Change from baseline in child body mass index z-score (zBMI)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Clinically significant weight loss
Description
Proportion of children achieving adiposity reduction of at least 0.25 zBMI
Time Frame
12 months
Title
Cost-effectiveness
Description
Incremental cost-effectiveness ratio of home-based vs medical center treatment, calculated from societal perspective.
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Intervention dosage
Description
Dosage of intervention received in each arm, in units of clock time of intervention delivered
Time Frame
12 months
Title
Treatment recommendations
Description
Number of specific treatment recommendations provided to each family
Time Frame
12 months
Title
Change in the home food environment
Description
Number of obesity-promoting foods and beverages present in the home, measured by staff audits
Time Frame
12 months
Title
Change in the home physical activity and media environment
Description
Sports equipment and media devices in the home, measured by staff audits
Time Frame
12 months
Title
Change in family routines
Description
Family routines associated with childhood obesity risk, assessed through the Family Nutrition and Physical Activity Screening Tool
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
This plan is to be determined.
Citations:
PubMed Identifier
31740429
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.
Results Reference
derived
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Creating Healthy Environments for Chicago Kids
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