Efficacy of a Clinic-based, Multi- Disciplinary, Pediatric Weight Management Program (REWARD Teens)
Primary Purpose
Body Weight Changes
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
multidisciplinary, behavior modification
Sponsored by
About this trial
This is an interventional treatment trial for Body Weight Changes
Eligibility Criteria
Inclusion Criteria:
- Phone screening
- Approval to participate in a weight management program from the child's pediatrician
- Children between the ages of 12 and 18 years
- Children overweight (>85th-<95th BMI percentile) or obese (>95th BMI percentile)
Exclusion Criteria:
- Children with evidence of significant cardiovascular disease or cardiac arrhythmias
- Children with liver disease
- Children on chronic use of medications including diuretics, steroids and adrenergic-stimulating agents
- Children with emotional problems such as clinical depression or other diagnosed psychological condition and currently use prescription medication for psychological conditions
- Children with evidence of family and/or medical neglect or physical, mental or sexual child abuse
Sites / Locations
- University of VermontRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
multidisciplinary, behavior modification
Arm Description
Outcomes
Primary Outcome Measures
weight loss
Body weight will be measured at baseline and at 12-weeks. Mean percentage weight change will be assessed following the 12-week intervention.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01857791
Brief Title
Efficacy of a Clinic-based, Multi- Disciplinary, Pediatric Weight Management Program
Acronym
REWARD Teens
Official Title
Efficacy of a Clinic-based, Multi- Disciplinary, Pediatric Weight Management Program
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2011 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Vermont
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Childhood obesity has more than tripled in the past 30 years. From 1980 to 2008, the prevalence of obesity among adolescents aged 12 to 18 years, increased from 5.0% to 18.1%.1 Although several pediatric weight management programs are available, access to these programs may not always be possible.
The proposed study will be an ongoing research program with approximately 40 children ages 12-18 years enrolled into the study over a year. All study participants will participate in a baseline evaluation which will include body composition measures, aerobic testing, as well as nutrition and physical activity questionnaires. Study participants will be assigned to the clinic-based group. The clinic- based group will participate in a 12-week multi-disciplinary weight management program. All study participants will then participate in a 12-week follow-up evaluation similar to the baseline visit. New participants will be enrolled every 12 weeks. Every 12 weeks, active participants (those that have completed a minimum of 12 weeks) will have the option to continue in the program or, discontinue their active participation in the program and enroll into the maintenance phase which will consist of measures only every 12 weeks.
The objective of the proposed study includes examining the efficacy of the clinic-based, multi-disciplinary, pediatric weight management program.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Body Weight Changes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
multidisciplinary, behavior modification
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
multidisciplinary, behavior modification
Primary Outcome Measure Information:
Title
weight loss
Description
Body weight will be measured at baseline and at 12-weeks. Mean percentage weight change will be assessed following the 12-week intervention.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Phone screening
Approval to participate in a weight management program from the child's pediatrician
Children between the ages of 12 and 18 years
Children overweight (>85th-<95th BMI percentile) or obese (>95th BMI percentile)
Exclusion Criteria:
Children with evidence of significant cardiovascular disease or cardiac arrhythmias
Children with liver disease
Children on chronic use of medications including diuretics, steroids and adrenergic-stimulating agents
Children with emotional problems such as clinical depression or other diagnosed psychological condition and currently use prescription medication for psychological conditions
Children with evidence of family and/or medical neglect or physical, mental or sexual child abuse
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Connie Tompkins, PhD
Phone
8026563817
Email
Connie.Tompkins@uvm.edu
Facility Information:
Facility Name
University of Vermont
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05405
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Connie Tompkins, PhD
Phone
802-656-3817
Email
Connie.Tompkins@uvm.edu
First Name & Middle Initial & Last Name & Degree
Connie Tompkins, PhD
12. IPD Sharing Statement
Learn more about this trial
Efficacy of a Clinic-based, Multi- Disciplinary, Pediatric Weight Management Program
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