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This study will evaluate the preliminary efficacy of a school-based weight management program for underserved adolescents. The program was designed with a phased treatment structure to provide more intensive treatment to participants who do not respond to treatment initially. Specifically, this study aims to examine differences in zBMI over time between students who do not respond to the first semester and receive more intensive treatment in the second semester, responders to first semester who receive more intensive treatment in the second semester, non-responders to the first semester who receive usual treatment in the second semester, and responders who receive usual treatment in the second semester at the end of the second semester, 1 year follow-up, and 2 year follow-up.
Childhood obesity has reached epidemic proportions. Schools have been identified as a focal point for intervention because children spend almost half their day in school. On average, school-based interventions have shown modest short-term improvements in weight outcomes. However, considerable individual variation is found within treatments. Current clinical guidelines for childhood obesity recommend a staged treatment approach in which every few months treatment plans are reevaluated based on an individual's progress toward weight outcomes. When an individual doesn't sufficiently progress toward outcome goals, his/her treatment is escalated to be more individualized, include more structure, and greater social support. This method parallels a treatment paradigm used in other areas of medical treatment in which medication type and dose are altered when an individual does not respond to initial care. Obesity treatment provided in the school setting does not follow a similar structure of care. Despite the recognized variation between individuals, school-based obesity interventions are typically evaluated by mean changes in weight outcomes over time. Although this is sufficient to evaluate the efficacy of a program, it does not identify individuals who are not responsive to treatment. Following clinical best practices, it is likely that treatment needs to be escalated for those who do not respond to initial treatment. Currently no escalated treatment options, like that provided in clinical settings, are available in schools. This is a critical gap given the immense individual variability to treatment response and pediatric tracking of BMI. This study will develop and evaluate an escalated school-based treatment for individuals resistant to initial treatment, called Take CHARGE! (Teens Committed to Health through Activity, Relationships, and Good Eating). Specifically, a pilot randomized control trial will A.) examine differences in zBMI between Take CHARGE and a treatment as usual condition over an academic school semester among low SES, racial/ethnic minority youth resistant to initial treatment, and will B.) determine the proportion of students resistant to school-based behavioral obesity treatment. Understanding the proportion of children who are resistant to school-based intervention is a critical first step in treating this high-risk group of children.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ReCHARGE | Experimental | intervention intensity is increased through: the creation of family groups, greater involvement of school staff, separate lessons for females, health screeners will be home and families are invited to a nutrition counseling session with a registered dietitian. |
|
| Treatment as Usual (TAU) | Active Comparator | PE class as usual which consisted of choice time. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ReCHARGE | Behavioral | During their PE class, all participants (both arms) participate in an intensive lifestyle intervention with established efficacy among this population for the academic fall semester. The following semester, participants are randomized to different treatment arms. ReCHARGE increases the intensity of treatment provided in the first semester by increasing social support and addressing common barriers youth have to adhering to intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Standardized BMI | Examine zBMI over the course of the intervention between study arms | up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Social Network | students asked to list their friends in the class | up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Carotenoid levels | Veggie Meter carotenoid measures | up to two years |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Craig A Johnston, PhD | University of Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| YES Prep Brays Oaks | Houston | Texas | 77031 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34417553 | Derived | Arlinghaus KR, O'Connor DP, Ledoux TA, Hughes SO, Johnston CA. A staged approach to address youth unresponsive to initial obesity intervention: a randomized clinical trial. Int J Obes (Lond). 2021 Dec;45(12):2585-2590. doi: 10.1038/s41366-021-00940-0. Epub 2021 Aug 20. |
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| ID | Term |
|---|---|
| D063766 | Pediatric Obesity |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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|
| TAU | Behavioral | PE class as usual led by PE teacher. |
|
| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |