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Barriers to Treatment in Obese Adolescents
This study has been completed.
Sponsor:
Virginia Commonwealth University
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
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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: | Intervention Model: Single Group Assignment Masking: Open Label |
| Official Title: | Understanding The Barriers in Treatment of Obesity in Adolescents 11-18 in Central Virginia |
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 ]
- Improvement in metabolic indicators. [ Time Frame: 6 months and 1 year ]
- Improvement in fitness measures [ Time Frame: 6 months and 1 year ]
Secondary Outcome Measures:
- 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 ]
| 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 (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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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
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:
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
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 |
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 June 28, 2017