Trial record 5 of 248 for:    Open Studies | "Body Weight Changes"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by University of Vermont
Sponsor:
Information provided by (Responsible Party):
Connie Tompkins, PhD, University of Vermont
ClinicalTrials.gov Identifier:
NCT01857791
First received: May 15, 2013
Last updated: NA
Last verified: May 2013
History: No changes posted
  Purpose

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.


Condition Intervention
Body Weight Changes
Behavioral: multidisciplinary, behavior modification

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy of a Clinic-based, Multi- Disciplinary, Pediatric Weight Management Program

Further study details as provided by University of Vermont:

Primary Outcome Measures:
  • weight loss [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Body weight will be measured at baseline and at 12-weeks. Mean percentage weight change will be assessed following the 12-week intervention.


Estimated Enrollment: 40
Study Start Date: January 2011
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: multidisciplinary, behavior modification Behavioral: multidisciplinary, behavior modification

  Eligibility

Ages Eligible for Study:   12 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01857791

Contacts
Contact: Connie Tompkins, PhD 8026563817 Connie.Tompkins@uvm.edu

Locations
United States, Vermont
University of Vermont Recruiting
Burlington, Vermont, United States, 05405
Contact: Connie Tompkins, PhD    802-656-3817    Connie.Tompkins@uvm.edu   
Principal Investigator: Connie Tompkins, PhD         
Sponsors and Collaborators
University of Vermont
  More Information

No publications provided

Responsible Party: Connie Tompkins, PhD, Assistant Professor, University of Vermont
ClinicalTrials.gov Identifier: NCT01857791     History of Changes
Other Study ID Numbers: M11-083
Study First Received: May 15, 2013
Last Updated: May 15, 2013
Health Authority: United States: Institutional Review Board, UVM Committee on Human Research in the Medical Sciences

Additional relevant MeSH terms:
Body Weight
Body Weight Changes
Signs and Symptoms

ClinicalTrials.gov processed this record on July 22, 2014