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Creating Healthy Environments for Chicago Kids (CHECK)

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ClinicalTrials.gov Identifier: NCT03195790
Recruitment Status : Recruiting
First Posted : June 22, 2017
Last Update Posted : September 11, 2019
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Rush University Medical Center

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

Condition or disease Intervention/treatment Phase
Childhood Obesity Behavioral: Family-based pediatric obesity treatment Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 266 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled trial
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: Outcomes assessors, PI, and some co-investigators will be blinded to group assignment.
Primary Purpose: Treatment
Official Title: Value and Mechanisms of Home Visitation in Obesity Interventions for Low-income Children
Actual Study Start Date : August 8, 2017
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021

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.




Primary Outcome Measures :
  1. Child adiposity [ Time Frame: 12 months ]
    Change from baseline in child body mass index z-score (zBMI)


Secondary Outcome Measures :
  1. Clinically significant weight loss [ Time Frame: 12 months ]
    Proportion of children achieving adiposity reduction of at least 0.25 zBMI

  2. Cost-effectiveness [ Time Frame: 12 months ]
    Incremental cost-effectiveness ratio of home-based vs medical center treatment, calculated from societal perspective.


Other Outcome Measures:
  1. Intervention dosage [ Time Frame: 12 months ]
    Dosage of intervention received in each arm, in units of clock time of intervention delivered

  2. Treatment recommendations [ Time Frame: 12 months ]
    Number of specific treatment recommendations provided to each family

  3. Change in the home food environment [ Time Frame: 12 months ]
    Number of obesity-promoting foods and beverages present in the home, measured by staff audits

  4. Change in the home physical activity and media environment [ Time Frame: 12 months ]
    Sports equipment and media devices in the home, measured by staff audits

  5. Change in family routines [ Time Frame: 12 months ]
    Family routines associated with childhood obesity risk, assessed through the Family Nutrition and Physical Activity Screening Tool



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Ages Eligible for Study:   6 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03195790


Contacts
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Contact: Bradley M Appelhans, PhD 312-942-3477 brad_appelhans@rush.edu

Locations
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United States, Illinois
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Michele Li, MS, RD    312-942-8260      
Principal Investigator: Bradley M Appelhans, PhD         
Sponsors and Collaborators
Rush University Medical Center
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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Responsible Party: Rush University Medical Center
ClinicalTrials.gov Identifier: NCT03195790     History of Changes
Other Study ID Numbers: 15120306
R01DK111358 ( U.S. NIH Grant/Contract )
First Posted: June 22, 2017    Key Record Dates
Last Update Posted: September 11, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: This plan is to be determined.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Obesity
Pediatric Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms