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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK111358 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Medical center treatment arm | Active Comparator | Family-based pediatric obesity treatment delivered at an urban medical center. |
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| Home treatment arm | Experimental | Family-based pediatric obesity treatment delivered in the family's home. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Child adiposity | Change from baseline in child body mass index z-score (zBMI) | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Clinically significant weight loss | Proportion of children achieving adiposity reduction of at least 0.25 zBMI | 12 months |
| Cost-effectiveness | Incremental cost-effectiveness ratio of home-based vs medical center treatment, calculated from societal perspective. |
| Measure | Description | Time Frame |
|---|---|---|
| Intervention dosage | Dosage of intervention received in each arm, in units of clock time of intervention delivered | 12 months |
| Treatment recommendations | Number of specific treatment recommendations provided to each family |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31740429 | Derived | 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. |
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This plan is to be determined.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jun 19, 2019 | Apr 12, 2021 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D063766 | Pediatric Obesity |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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Randomized controlled trial
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Outcomes assessors, PI, and some co-investigators will be blinded to group assignment.
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| 12 months |
| 12 months |
| Change in the home food environment | Number of obesity-promoting foods and beverages present in the home, measured by staff audits | 12 months |
| Change in the home physical activity and media environment | Sports equipment and media devices in the home, measured by staff audits | 12 months |
| Change in family routines | Family routines associated with childhood obesity risk, assessed through the Family Nutrition and Physical Activity Screening Tool | 12 months |
| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |