An interventional study of ReCHARGE and TAU in Obesity, Childhood, sponsored by University of Houston. Status unknown at 1 site in United States. Open to participants aged 10 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-04-24.
Sponsored by University of Houston · Not applicable, Interventional, and Treatment
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.
1,117 studies on the registry are indexed under Pediatric Obesity; 189 are open to participants now.
This study's enrollment of 392 is above the median of 103 across 862 interventional studies indexed under Pediatric Obesity.
Browse Pediatric Obesity studies →University of Houston is the lead sponsor of 101 studies on the registry; 17 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 3 (33%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Behavioral: ReCHARGE
PE class as usual which consisted of choice time.
Behavioral: TAU
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.
PE class as usual led by PE teacher.
Standardized BMI
Examine zBMI over the course of the intervention between study arms
Time frame: up to 2 years
Social Network
students asked to list their friends in the class
Time frame: up to 6 months
Carotenoid levels
Veggie Meter carotenoid measures
Time frame: up to two years
Plan to share: No
This study is status unknown, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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University of Houston