Efficacy of a Clinic-based, Multi- Disciplinary, Pediatric Weight Management Program (REWARD Teens)

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.

Study Overview

• Status: Unknown
• Conditions: Body Weight Changes
• Intervention / Treatment: Behavioral: multidisciplinary, behavior modification

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Connie Tompkins, PhD; Phone Number: 8026563817; Email: Connie.Tompkins@uvm.edu

Study Locations

• United States
  • Vermont
    • Burlington, Vermont, United States, 05405
      • Recruiting
      • University of Vermont
      • Contact: Connie Tompkins, PhD; Phone Number: 802-656-3817; Email: Connie.Tompkins@uvm.edu
      • Principal Investigator: Connie Tompkins, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: multidisciplinary, behavior modification	Behavioral: multidisciplinary, behavior modification

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 weeks

Collaborators and Investigators

• Sponsor: University of Vermont

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Anticipated): December 1, 2016
• Study Completion: December 7, 2022

Study Registration Dates

• First Submitted: May 15, 2013
• First Submitted That Met QC Criteria: May 15, 2013
• First Posted (Estimate): May 20, 2013

Study Record Updates

• Last Update Posted (Estimate): September 10, 2015
• Last Update Submitted That Met QC Criteria: September 9, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes
• Other Study ID Numbers: M11-083

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No