Creating Healthy Environments for Chicago Kids

Childhood Obesity Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03195790
• Other study ID #: 15120306
• Secondary ID: R01DK111358
• Status: Completed
• Phase: N/A
• Start date: August 8, 2017
• Est. completion date: September 19, 2022

Study information

• Verified date: October 2022
• Source: Rush University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 269
• Est. completion date: September 19, 2022
• Est. primary completion date: September 19, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 11 Years

Eligibility

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

Related Conditions & MeSH terms

• Childhood Obesity
• Obesity
• Pediatric Obesity

Intervention

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.

Locations

Country	Name	City	State
United States	Rush University Medical Center	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Rush University Medical Center	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Intervention dosage	Dosage of intervention received in each arm, in units of clock time of intervention delivered	12 months
Other	Treatment recommendations	Number of specific treatment recommendations provided to each family	12 months
Other	Change in the home food environment	Number of obesity-promoting foods and beverages present in the home, measured by staff audits	12 months
Other	Change in the home physical activity and media environment	Sports equipment and media devices in the home, measured by staff audits	12 months
Other	Change in family routines	Family routines associated with childhood obesity risk, assessed through the Family Nutrition and Physical Activity Screening Tool	12 months
Primary	Child adiposity	Change from baseline in child body mass index z-score (zBMI)	12 months
Secondary	Clinically significant weight loss	Proportion of children achieving adiposity reduction of at least 0.25 zBMI	12 months
Secondary	Cost-effectiveness	Incremental cost-effectiveness ratio of home-based vs medical center treatment, calculated from societal perspective.	12 months