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Completed

NCT Number: NCT00167830

Barriers to Treatment in Obese Adolescents

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

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Key information

Conditions

Obesity Behavior Body Weight Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Health Behavior Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Patient Acceptance of Health Care Patient Compliance Signs and Symptoms Treatment Adherence and Compliance

Age range

11 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Motivational Interviewing

Behavioral

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.

Strength and Cardiovascular Conditioning

Behavioral

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.

Food selection and portion control

Behavioral

Subjects meet on a biweekly basis with a registered dietitian who presents educational information about healthy food selection and portion control.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Collaborators

  • VA Premier Health

Registry information

Official study title

Understanding The Barriers in Treatment of Obesity in Adolescents 11-18 in Central Virginia

Important dates

Study start
2003
Primary completion
2013
Study completion
2013
First posted
Sep 14, 2005
Registry last updated
Jan 20, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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