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
  Purpose

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 Intervention Phase
Obesity
Behavioral: Motivational Interviewing
Behavioral: Strength and Cardiovascular Conditioning
Behavioral: Food selection and portion control
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Understanding The Barriers in Treatment of Obesity in Adolescents 11-18 in Central Virginia

Resource links provided by NLM:


Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 292
Study Start Date: November 2003
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Ages Eligible for Study:   11 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00167830

Locations
United States, Virginia
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
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT00167830     History of Changes
Other Study ID Numbers: 760
Study First Received: September 9, 2005
Last Updated: January 16, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Virginia Commonwealth University:
Pediatric Overweight,
African American;
Adolescent;
Intervention,
Teasing;
Self-esteem
Quality of Life
Metabolic syndrome
Insulin resistance
Diabetes
Nutrition
Motivation
Culture
BMI
Cardiorespiratory fitness
Resistance Training
Compliance

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 01, 2014