| City: |
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Richmond |
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State:
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VA |
| Zip Code: |
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23298 |
| Conditions: |
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Overweight |
| Purpose: |
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The current study aims to investigate the impact of a comprehensive, team-based,
family-centered, lifestyle modification program on body weight, metabolic abnormalities,
fitness measures, and self-esteem in overweight adolescents beginning the study at ages
11-18 years. The intensive program will uniquely include a "team" structure and a component
designed to address the role of parental modeling in effective lifestyle changes. By
comparing the demographic, psychosocial, and metabolic characteristics of adolescents
according to the degree of weight loss, the study will also more fully characterize the
barriers that prevent successful participation in an intensive lifestyle modification
program.
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| Study summary: |
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The study will annually enroll 100 - 200 adolescent male and female subjects between 11 and
18 years of age with a BMI > the 85th percentile and one parent. Adolescents enrolled in
the study, will participate in a structured exercise program and meet regularly with a
dietitian and behavior specialist for nutrition education and review and update of progress
and goals. The study is designed for 2 years of participation with data collection points
at baseline, 3 months, 6 months, 1 year and 2 years. Data collected from adolescents
include demographic information anthropometric information (height, weight, blood pressure,
temperature, pulse, percent body fat); assessments of nutritional knowledge, food choices
and dietary intake; assessments of activity and fitness level of behavioral status
(depression, self-esteem, self-confidence, satisfaction with life, happiness, perspectives
on health, exercise and diet, family environment, quality of life, body awareness, teasing,
social efficacy, self-perception, coping mechanisms), assessments of sleep time and quality
and physiological and medical data (including blood and urine tests)
Parents will accompany their children to the nutrition and behavior support visits, and
attend 12 group educational sessions to learn skills and strategies to help their children
adopt healthier eating and exercise behaviors. Data collected from parents will include
demographic, anthropometric measures (height, weight, blood pressure, temperature, pulse,
percent body fat); and assessments of activity level, dietary intake and eating habits,
behavioral status, child-feeding practices, and understanding of their child. |
| Criteria: |
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Inclusion Criteria:
- Age between 11 and 18
- BMI at or above the 85th percentile for age and sex
- At least one adult in the household who is committed to come to the program meetings
Exclusion Criteria:
- Previous enrollment in VCU IRB 3354
- Underlying genetic, neurologic, endocrine, or metabolic conditions that preclude
weight loss with conventional diet and exercise programs
- Weight greater than 400 pounds
- Pregnancy in female adolescent subjects
- Inability to understand program instructions due to language barrier or a mental
disability
- Primary residence outside a 30 mile radius program facility.
- Primary participating parent, if female, cannot be pregnant during the period
corresponding to the parents intervention. |
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| Study is available at: |
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Virginia Commonwealth University
Richmond, VA 23298
United States
Primary Contact:
Janet D. Delorme, M.S.
Email: jdelorme@vcu.edu
Phone: 804-827-0661
Secondary Contact:
Janet D Delorme, M.S.
Email: jdelorme@vcu.edu
Phone: 804-827-0661 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 22, 2011 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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