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

NCT01857791 | Unknown

• 1 other identifier: M11-083
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

multidisciplinary, behavior modification

EXPERIMENTAL

Behavioral: multidisciplinary, behavior modification

Interventions

multidisciplinary, behavior modification BEHAVIORAL

multidisciplinary, behavior modification

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Vermont: lead

Study Sites (1)

University of Vermont

Burlington, Vermont, 05405, United States

RECRUITING

MeSH Terms

Conditions

Body Weight Changes

Interventions

Behavior Therapy

Condition Hierarchy (Ancestors)

Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Connie Tompkins, PhD

CONTACT

8026563817; Connie.Tompkins@uvm.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 15, 2013
• First Posted: May 20, 2013
• Study Start: January 1, 2011
• Primary Completion: December 1, 2016
• Last Updated: September 10, 2015

Record last verified: 2015-09

Locations

US (1)