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

Body Weight Changes Clinical Trial

— REWARD Teens  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01857791
• Other study ID #: M11-083
• Status: Recruiting
• Phase: N/A
• First received: May 15, 2013
• Last updated: September 9, 2015
• Start date: January 2011

Study information

• Verified date: September 2015
• Source: University of Vermont
• Contact: Connie Tompkins, PhD
• Phone: 8026563817
• Email: Connie.Tompkins[@]uvm.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board, UVM Committee on Human Research in the Medical Sciences
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 18 Years

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Body Weight
• Body Weight Changes

Intervention

Behavioral:
• multidisciplinary, behavior modification

Locations

Country	Name	City	State
United States	University of Vermont	Burlington	Vermont

Sponsors (1)

Lead Sponsor	Collaborator
University of Vermont

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No