Barriers to Treatment in Obese Adolescents

This study has been completed.
Sponsor:
Collaborator:
VA Premier Health
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT00167830
First received: September 9, 2005
Last updated: January 16, 2014
Last verified: January 2014

September 9, 2005
January 16, 2014
November 2003
December 2013   (final data collection date for primary outcome measure)
  • A decrease in body mass index. [ Time Frame: 6 months and 1 year ] [ Designated as safety issue: No ]
  • Improvement in metabolic indicators. [ Time Frame: 6 months and 1 year ] [ Designated as safety issue: No ]
  • Improvement in fitness measures [ Time Frame: 6 months and 1 year ] [ Designated as safety issue: No ]
  • A decrease in body mass index.
  • Improvement in metabolic indicators.
  • Improvement in fitness measures
Complete list of historical versions of study NCT00167830 on ClinicalTrials.gov Archive Site
  • Improved subject compliance with exercise and diet. [ Time Frame: 6 months and 1 year ] [ Designated as safety issue: No ]
  • Improved parental compliance and support. [ Time Frame: 6 months and 1 year ] [ Designated as safety issue: No ]
  • Increase knowledge of nutritional principles [ Time Frame: 6 months and 1 year ] [ Designated as safety issue: No ]
  • Improved attitude toward healthy behaviors [ Time Frame: 6 months and 1 year ] [ Designated as safety issue: No ]
  • Increased self-esteem and motivation [ Time Frame: 6 months and 1 year ] [ Designated as safety issue: No ]
  • Decreased negativity [ Time Frame: 6 months and 1 year ] [ Designated as safety issue: No ]
  • Improved family cohesiveness [ Time Frame: 6 months and 1 year ] [ Designated as safety issue: No ]
  • Improved subject compliance with exercise and diet.
  • Improved parental compliance and support.
  • Increase knowledge of nutritional principles
  • Improved attitude toward healthy behaviors
  • Increased self-esteem and motivation
  • Decreased negativity
  • Improved family cohesiveness
Not Provided
Not Provided
 
Barriers to Treatment in Obese Adolescents
Understanding The Barriers in Treatment of Obesity in Adolescents 11-18 in Central Virginia

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

  • 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.
Interventional
Phase 1
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Obesity
  • Behavioral: Motivational Interviewing
    Biweekly meetings with a behavior specialist to review subject's progress with the protocol and explore challenges subject is facing in adopting healthy lifestyle behaviors.
  • Behavioral: Strength and Cardiovascular Conditioning
    Subjects take part in an exercise program to include 30 minutes of cardiorespiratory exercise at 70% maximum heart rate, and 30 minutes of strength training on Nautilus machines.
  • Behavioral: Food selection and portion control
    Subjects meet on a biweekly basis with a registered dietitian who presents educational information about healthy food selection and portion control.
Experimental: Lifestyle Intervention
Dietary modification and exercise.
Interventions:
  • Behavioral: Motivational Interviewing
  • Behavioral: Strength and Cardiovascular Conditioning
  • Behavioral: Food selection and portion control

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
292
December 2013
December 2013   (final data collection date for primary outcome measure)

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
Both
11 Years to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00167830
760
Yes
Virginia Commonwealth University
Virginia Commonwealth University
VA Premier Health
Principal Investigator: Edmond Wickham, M.D. Virginia Commonwealth University Depts. of Internal Medicine and Pediatrics
Virginia Commonwealth University
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP