Barriers to Treatment in Obese Adolescents

Phase 1

Completed

• Conditions: Obesity

• Registration Number: NCT00167830
• Lead Sponsor: Virginia Commonwealth University

Brief Summary

The purpose of this study is to identify significant racial and ethnical differences in risk factors for development of obesity and weight loss in adolescents in Central Virginia

Detailed Description

* Participation for 6 months in a program incorporating exercise, nutritional counseling and behavioral support leads to measurable improvements in overall fitness, metabolic indicators and loss of body fat for obese adolescents.

* Degree of loss of body fat, improved overall fitness and improvements in metabolic indicators can be correlated with the degree of compliance and participation for 6 months in the program.

* Parental involvement and support can be correlated with the degree of compliance and participation in the program.

* Socioeconomic factors can be correlated with the degree of compliance and participation in the program.

* Cultural differences in diet, attitudes toward body shape, and family dynamics can be correlated with success or failure in a weight loss program.

* Individual differences in self-esteem, self-discipline and feelings of connectedness with family members can be correlated with success or failure in a weight loss program.

Study Timeline

• Study Start: 2003-11
• Study First Submitted: 2005-09-09
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-14
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-16
• Last Update Posted: 2014-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 292

Inclusion Criteria

• Age 11-18
• Above 95th percentile for weight
• Reside within 30 miles of program site
• Ability to comprehend basic instructions
• Ability to perform basic exercise movements

Exclusion Criteria

• Having a metabolic disorder that causes weight gain
• Having a cognitive deficit that impacts learning and comprehension
• Having a physical defect that prevents exercise

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Improvement in metabolic indicators.	6 months and 1 year
A decrease in body mass index.	6 months and 1 year
Improvement in fitness measures	6 months and 1 year

Secondary Outcome Measures

Name	Time	Method
Increase knowledge of nutritional principles	6 months and 1 year
Improved attitude toward healthy behaviors	6 months and 1 year
Increased self-esteem and motivation	6 months and 1 year
Decreased negativity	6 months and 1 year
Improved family cohesiveness	6 months and 1 year
Improved subject compliance with exercise and diet.	6 months and 1 year
Improved parental compliance and support.	6 months and 1 year

Trial Locations

Locations (1)

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States