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Barriers to Treatment in Obese Adolescents

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ClinicalTrials.gov Identifier: NCT00167830
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : January 20, 2014
Sponsor:
Collaborator:
VA Premier Health
Information provided by (Responsible Party):
Virginia Commonwealth University

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Obesity 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 292 participants
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 : November 2003
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013
Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. A decrease in body mass index. [ Time Frame: 6 months and 1 year ]
  2. Improvement in metabolic indicators. [ Time Frame: 6 months and 1 year ]
  3. Improvement in fitness measures [ Time Frame: 6 months and 1 year ]

Secondary Outcome Measures :
  1. Improved subject compliance with exercise and diet. [ Time Frame: 6 months and 1 year ]
  2. Improved parental compliance and support. [ Time Frame: 6 months and 1 year ]
  3. Increase knowledge of nutritional principles [ Time Frame: 6 months and 1 year ]
  4. Improved attitude toward healthy behaviors [ Time Frame: 6 months and 1 year ]
  5. Increased self-esteem and motivation [ Time Frame: 6 months and 1 year ]
  6. Decreased negativity [ Time Frame: 6 months and 1 year ]
  7. Improved family cohesiveness [ Time Frame: 6 months and 1 year ]

Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   11 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:
Stern M, Mazzeo SE, Porter J, Gerke C, Bryan D,and Laver J. Self-esteem, teasing and quality of life: African American adolescent girls participating in a family-based pediatric overweight intervention. Journal of Clinical Psychology in Medical Settings. DOI:10.1007/s10880-006-9029-4, 2006

Other Publications:

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
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: January 20, 2014
Last Verified: January 2014

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