Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
238 participants
INTERVENTIONAL
2005-01-31
2010-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
NONE
Study Groups
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MR-/REDE-
Weight Loss through cognitive behavioral therapy and meal replacement use, and continued therapy for weight loss maintenance.
Weight Loss Phase
Weight loss using CBT and meal replacements
Continued CBT
Using CBT during weight loss maintenance
MR+/REDE-
Weight Loss through cognitive behavioral therapy and meal replacement use, and continued therapy and use of meal replacements for weight loss maintenance.
Weight Loss Phase
Weight loss using CBT and meal replacements
Continued CBT
Using CBT during weight loss maintenance
continued use of meal replacements
continued use of meal replacements during weight loss maintenance
MR-/REDE+
Weight Loss through cognitive behavioral therapy and meal replacement use, and continued therapy as well as Reduced Energy Density Education for weight loss maintenance.
Weight Loss Phase
Weight loss using CBT and meal replacements
Continued CBT
Using CBT during weight loss maintenance
reduced energy density education
Additional nutritional learning
MR+/REDE+
Weight Loss through cognitive behavioral therapy and meal replacement use, and continued therapy, as well as Reduced Energy Density Education and continued meal replacement use, for weight loss maintenance.
Weight Loss Phase
Weight loss using CBT and meal replacements
Continued CBT
Using CBT during weight loss maintenance
reduced energy density education
Additional nutritional learning
continued use of meal replacements
continued use of meal replacements during weight loss maintenance
Interventions
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Weight Loss Phase
Weight loss using CBT and meal replacements
Continued CBT
Using CBT during weight loss maintenance
reduced energy density education
Additional nutritional learning
continued use of meal replacements
continued use of meal replacements during weight loss maintenance
Eligibility Criteria
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Inclusion Criteria
* Access to a telephone and voice mail/answering machine
* MUST be seeing a primary care physician working with us on this study (in the greater Philadelphia area)
Exclusion Criteria
* Current bi-polar, depression, substance abuse, or dependence disorder
* Living with someone already enrolled
* Enrolled in another weight loss program
* Current disorder/medications affecting body weight or energy expenditure (e.g. thyroid disease)
* Myocardial infraction within the past three months
* Unstable angina
* Nephrotic syndrome/malabsorptive disease
* Gout attack within the past year
* Lactating/pregnant (or planning within next two years)
* Current/recent history of cancer, neurological disease, high creatinine levels, active hepatic disease
18 Years
70 Years
ALL
No
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Drexel University
OTHER
Responsible Party
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Drexel University
Principal Investigators
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Michael R Lowe, PhD
Role: PRINCIPAL_INVESTIGATOR
Drexel University
Locations
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Drexel University
Philadelphia, Pennsylvania, United States
Countries
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Other Identifiers
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DK66759 (completed)
Identifier Type: -
Identifier Source: org_study_id
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