Childhood Obesity
Conditions
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 6-12 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.
Interventions
BEHAVIORALFamily-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.
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Rush University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Outcomes assessors, PI, and some co-investigators will be blinded to group assignment.
Intervention model description
Randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Child adiposity | 12 months | Change from baseline in child body mass index z-score (zBMI) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinically significant weight loss | 12 months | Proportion of children achieving adiposity reduction of at least 0.25 zBMI |
| Cost-effectiveness | 12 months | Incremental cost-effectiveness ratio of home-based vs medical center treatment, calculated from societal perspective. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in the home physical activity and media environment | 12 months | Sports equipment and media devices in the home, measured by staff audits |
| Intervention dosage | 12 months | Dosage of intervention received in each arm, in units of clock time of intervention delivered |
| Change in family routines | 12 months | Family routines associated with childhood obesity risk, assessed through the Family Nutrition and Physical Activity Screening Tool |
| Treatment recommendations | 12 months | Number of specific treatment recommendations provided to each family |
| Change in the home food environment | 12 months | Number of obesity-promoting foods and beverages present in the home, measured by staff audits |
Countries
United States
Outcome results
None listed