Efficacy of a Clinic-based, Multi- Disciplinary, Pediatric Weight Management Program

NCT ID: NCT01857791

Last Updated: 2015-09-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31

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 Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

multidisciplinary, behavior modification

Group Type: EXPERIMENTAL

multidisciplinary, behavior modification

Intervention Type: BEHAVIORAL

Interventions

multidisciplinary, behavior modification

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Vermont

OTHER

Sponsor Role: lead

Responsible Party

Connie Tompkins, PhD

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Vermont

Burlington, Vermont, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Connie Tompkins, PhD

Role: CONTACT

Connie.Tompkins@uvm.edu

8026563817

Facility Contacts

Connie Tompkins, PhD

Role: primary

Connie.Tompkins@uvm.edu

802-656-3817

Other Identifiers

M11-083

Identifier Type: -

Identifier Source: org_study_id