Weight Loss Maintenance in Primary Care
After a three month weight loss phase involving the use of meal replacements, participants are randomized into different weight loss maintenance conditions. Aim 1: To test the hypothesis that the meal replacement (MR) and reduced energy density eating (REDE) interventions, when added separately to the LEARN program, will produce superior weight loss maintenance compared to a LEARN-only intervention. Aim 2: To test the hypothesis that the weight loss maintenance condition that combines MRs and REDE will produce better maintenance of weight losses than either individual component and than the LEARN-only condition. Aim 3: To test the hypothesis that the two conditions receiving the REDE intervention will experience longer-lasting improvements in the energy density and nutritional composition of the diet compared to the two non-REDE conditions.
Status: Completed (N/A). Started on January 1st, 2005.
Enrollment: 238 subjects
Study Type: Interventional
Study Design:
- Allocation: Randomized
- Endpoint Classification: Efficacy Study
- Intervention Model: Factorial Assignment
- Masking: Open Label
- Primary Purpose: Treatment
Conditions:
Interventions:
- Behavioral: Weight Loss Phase
- Behavioral: Continued CBT
- Behavioral: reduced energy density education
- Behavioral: continued use of meal replacements
Eligibility
Inclusion Criteria:
BMI of 30, or BMI of 27 with weight-related comorbidities
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:
Previously/currently diagnosed with an eating disorder
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
- Gender
Both
- Mininum Age
18 Years
- Maximum Age
70 Years
- Healthy Volunteers
No
Resources
Source: Drexel University
Authority: United States: Federal Government
Locations
-
Drexel University
Philadelphia
Pennsylvania
19102
United States
Officials
Michael R Lowe, PhD (Principal Investigator, Drexel University)
Sponsors
Drexel University (Lead Sponsor)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (Collaborator)
References
None.
Links
None.
- Date Verified
- May 1st, 2011
- First Received
- May 24th, 2011
- Last Changed
- May 24th, 2011
Information obtained from ClinicalTrials.gov on June 09, 2011. Link to the current ClinicalTrials.gov record.
All data in the Healia Clinical Trials Information Database and content displayed by the Healia Clinical Trials Search Engine are licensed from the National Institutes of Health (National Library of Medicine), which collects and maintains the data.
The Healia Clinical Trials Search Engine searches the data set at clinicaltrials.gov, providing up-to-date information about current clinical trials. In the Healia Clinical Trials Database you can find information on new experimental drugs, medical devices, and other types of treatments for all types of diseases. Each clinical trial description includes information about the phase of the trial (phase I, phase II, or phase III), the trial’s methods, such as whether it is a randomized, placebo controlled, double blind study, and the status of the trial including whether or not the trial is currently enrolling new participants.