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
|
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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 |
- 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 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 |
Arm | Intervention/treatment |
---|---|
Experimental: Lifestyle Intervention
Dietary modification and exercise.
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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.
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- A decrease in body mass index. [ Time Frame: 6 months and 1 year ]
- Improvement in metabolic indicators. [ Time Frame: 6 months and 1 year ]
- Improvement in fitness measures [ Time Frame: 6 months and 1 year ]
- Improved subject compliance with exercise and diet. [ Time Frame: 6 months and 1 year ]
- Improved parental compliance and support. [ Time Frame: 6 months and 1 year ]
- Increase knowledge of nutritional principles [ Time Frame: 6 months and 1 year ]
- Improved attitude toward healthy behaviors [ Time Frame: 6 months and 1 year ]
- Increased self-esteem and motivation [ Time Frame: 6 months and 1 year ]
- Decreased negativity [ Time Frame: 6 months and 1 year ]
- Improved family cohesiveness [ Time Frame: 6 months and 1 year ]

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Ages Eligible for Study: | 11 Years to 18 Years (Child, Adult) |
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

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
United States, Virginia | |
Virginia Commonwealth University | |
Richmond, Virginia, United States, 23298 |
Principal Investigator: | Edmond Wickham, M.D. | Virginia Commonwealth University Depts. of Internal Medicine and Pediatrics |
Publications of Results:
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 |