Teens Committed to Health Through Activity, Relationships, and Good Eating (Take CHARGE!)
Primary Purpose
Obesity, Childhood
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ReCHARGE
TAU
Sponsored by
About this trial
This is an interventional treatment trial for Obesity, Childhood
Eligibility Criteria
Inclusion Criteria:
- Aged 10-17 years old
- Student enrolled in a Physical Education (PE) class at the YES Prep Brays Oak Campus during either the 2018-2019 or 2019-2020 school year
- provides written parental consent and student assent
Exclusion Criteria:
- Is pregnant or becomes pregnant during the study.
- Is unable to participate in PE class for more than 5 consecutive school days.
- Does not meet all of the inclusion criteria listed above
Sites / Locations
- YES Prep Brays Oaks
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
ReCHARGE
Treatment as Usual (TAU)
Arm Description
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.
PE class as usual which consisted of choice time.
Outcomes
Primary Outcome Measures
Standardized BMI
Examine zBMI over the course of the intervention between study arms
Secondary Outcome Measures
Social Network
students asked to list their friends in the class
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04362280
Brief Title
Teens Committed to Health Through Activity, Relationships, and Good Eating
Acronym
Take CHARGE!
Official Title
Teens Committed to Health Through Activity, Relationships, and Good Eating (Take CHARGE!)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 20, 2018 (Actual)
Primary Completion Date
May 2020 (Anticipated)
Study Completion Date
September 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Houston
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Childhood
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
392 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ReCHARGE
Arm Type
Experimental
Arm Description
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.
Arm Title
Treatment as Usual (TAU)
Arm Type
Active Comparator
Arm Description
PE class as usual which consisted of choice time.
Intervention Type
Behavioral
Intervention Name(s)
ReCHARGE
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
TAU
Intervention Description
PE class as usual led by PE teacher.
Primary Outcome Measure Information:
Title
Standardized BMI
Description
Examine zBMI over the course of the intervention between study arms
Time Frame
up to 2 years
Secondary Outcome Measure Information:
Title
Social Network
Description
students asked to list their friends in the class
Time Frame
up to 6 months
Other Pre-specified Outcome Measures:
Title
Carotenoid levels
Description
Veggie Meter carotenoid measures
Time Frame
up to two years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Aged 10-17 years old
Student enrolled in a Physical Education (PE) class at the YES Prep Brays Oak Campus during either the 2018-2019 or 2019-2020 school year
provides written parental consent and student assent
Exclusion Criteria:
Is pregnant or becomes pregnant during the study.
Is unable to participate in PE class for more than 5 consecutive school days.
Does not meet all of the inclusion criteria listed above
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Craig A Johnston, PhD
Organizational Affiliation
University of Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
YES Prep Brays Oaks
City
Houston
State/Province
Texas
ZIP/Postal Code
77031
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34417553
Citation
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.
Results Reference
derived
Learn more about this trial
Teens Committed to Health Through Activity, Relationships, and Good Eating
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