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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00143962 |
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Date of registration:
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01/09/2005 |
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Primary sponsor: |
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Public title:
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Comparison of Two Approaches to Weight Loss Follow-Up Study
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Scientific title:
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Comparison of Two Approaches to Weight Loss Follow-Up Study |
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Date of first enrolment:
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March 1997 |
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Target sample size:
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00143962 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Diane Rosenbaum |
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Address:
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Telephone:
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Email:
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rdiane@mail.med.upenn.edu |
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Affiliation:
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Name:
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Holly Wyatt, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Colorado, Denver |
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Name:
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James Hill, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Colorado, Denver |
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Name:
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Gary Foster, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Pennsylvania |
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Name:
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Samuel Klein, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Washington University School of Medicine |
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Key inclusion & exclusion criteria
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Inclusion Criteria
- Body mass index between 30 and 40
- Live and work within 1 hour of the study site
- Stable psychological status Exclusion criteria
- History of heart disease, heart attack, or stroke
- Blood pressure >140/90 mmHg
- Abnormal cholesterol levels
- Significant psychiatric illness
- Any medication that affects weight or metabolic rate
- Presence or history of a chronic disease that is known to affect appetite, food
intake, or metabolism (i.e., diabetes, thyroid disease, or cancer)
- Currently using antidepressants, steroids, tobacco, or illegal drugs
- Pregnant, breastfeeding, or planning pregnancy
- 10 lb change in weight within 6 months of study entry
- History of malignant arrhythmias or cerebrovascular, renal, or hepatic
disease
- History of protein wasting diseases or gout
- Severe arthritis
- Osteoporosis
- Certain types of hormone replacement therapy
- Currently following a vegetarian diet
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Obesity
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Intervention(s)
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Behavioral: Low Carbohydrate Diet
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Primary Outcome(s)
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Obesity
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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