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Completed

NCT Number: NCT03195790

Creating Healthy Environments for Chicago Kids

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

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Key information

Conditions

Childhood Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pediatric Obesity Signs and Symptoms

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rush University Medical Center

Chicago, Illinois, 60612, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Family-based pediatric obesity treatment

Behavioral

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 outcomes

  1. Child adiposity

    Time frame: 12 months

    Change from baseline in child body mass index z-score (zBMI)

Secondary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Rush University Medical Center

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

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

Acronym: CHECK

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Jun 22, 2017
Registry last updated
Nov 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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