Barriers to Treatment in Obese Adolescents

Sponsor
Virginia Commonwealth University (Other)
Overall Status
Completed
CT.gov ID
NCT00167830
Collaborator
VA Premier Health (Other)
292
1
1
121
2.4

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Motivational Interviewing
  • Behavioral: Strength and Cardiovascular Conditioning
  • Behavioral: Food selection and portion control
Phase 1/Phase 2

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 Design

Study Type:
Interventional
Actual Enrollment :
292 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Official Title:
Understanding The Barriers in Treatment of Obesity in Adolescents 11-18 in Central Virginia
Study Start Date :
Nov 1, 2003
Actual Primary Completion Date :
Dec 1, 2013
Actual Study Completion Date :
Dec 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: Lifestyle Intervention

Dietary modification and exercise.

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.

Outcome Measures

Primary Outcome Measures

  1. A decrease in body mass index. [6 months and 1 year]

  2. Improvement in metabolic indicators. [6 months and 1 year]

  3. Improvement in fitness measures [6 months and 1 year]

Secondary Outcome Measures

  1. Improved subject compliance with exercise and diet. [6 months and 1 year]

  2. Improved parental compliance and support. [6 months and 1 year]

  3. Increase knowledge of nutritional principles [6 months and 1 year]

  4. Improved attitude toward healthy behaviors [6 months and 1 year]

  5. Increased self-esteem and motivation [6 months and 1 year]

  6. Decreased negativity [6 months and 1 year]

  7. Improved family cohesiveness [6 months and 1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:
11 Years to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Virginia Commonwealth University Richmond Virginia United States 23298

Sponsors and Collaborators

  • Virginia Commonwealth University
  • VA Premier Health

Investigators

  • Principal Investigator: Edmond Wickham, M.D., Virginia Commonwealth University Depts. of Internal Medicine and Pediatrics

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT00167830
Other Study ID Numbers:
  • 760
First Posted:
Sep 14, 2005
Last Update Posted:
Jan 20, 2014
Last Verified:
Jan 1, 2014

Study Results

No Results Posted as of Jan 20, 2014