Recruiting

Weight Management

Sponsor:

University of Vermont

Code:

NCT01857791

Conditions

Body Weight Changes

Eligibility Criteria

Sex: All

Age: 12 - 18

Healthy Volunteers: Not accepted

Interventions

multidisciplinary, behavior modification

Study Details

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.

Conditions

Body Weight Changes

Study ID

NCT01857791

Start date

Jan, 2011

Status verified date

Sep, 2015

Primary completion date

Dec, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 18

Healthy Volunteers: Not accepted

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 Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: multidisciplinary, behavior modification

Interventions

multidisciplinary, behavior modification

Primary outcome measure

  • weight loss [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Connie Tompkins, PhD

8026563817Connie.Tompkins@uvm.edu

Locations

University of Vermont

Recruiting

Burlington, Vermont, United States, 05405

Contacts

Connie Tompkins, PhD

802-656-3817Connie.Tompkins@uvm.edu

Principal Investigator:

Connie Tompkins, PhD

More Information

Sponsor

University of Vermont

Last update posted

Sep 10, 2015

Last verified

Sep, 2015

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Vermont on 2015-09-10.