Weight Loss Maintenance in Primary Care (PrimaryCare)
May 24, 2011 updated by: Drexel University
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
238
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19102
- Drexel University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: MR-/REDE-
Weight Loss through cognitive behavioral therapy and meal replacement use, and continued therapy for weight loss maintenance.
|
Weight loss using CBT and meal replacements
Using CBT during weight loss maintenance
|
|
Experimental: 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 using CBT and meal replacements
Using CBT during weight loss maintenance
continued use of meal replacements during weight loss maintenance
|
|
Experimental: 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 using CBT and meal replacements
Using CBT during weight loss maintenance
Additional nutritional learning
|
|
Experimental: 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 using CBT and meal replacements
Using CBT during weight loss maintenance
continued use of meal replacements during weight loss maintenance
Additional nutritional learning
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Weight
Time Frame: baseline, 3 months, 12 months, 24 months, 36 months
|
baseline, 3 months, 12 months, 24 months, 36 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Body composition
Time Frame: baseline, 3 months, 12 months, 24 months, 36 months
|
baseline, 3 months, 12 months, 24 months, 36 months
|
|
Blood work results
Time Frame: baseline, 3 months, 12 months, 24 months
|
baseline, 3 months, 12 months, 24 months
|
|
Scores on questionnaire-based measures
Time Frame: baseline, 3 months, 12 months, 24 months, 36 months
|
baseline, 3 months, 12 months, 24 months, 36 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Michael R Lowe, PhD, Drexel University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2005
Primary Completion (Actual)
August 1, 2010
Study Completion (Actual)
August 1, 2010
Study Registration Dates
First Submitted
April 3, 2007
First Submitted That Met QC Criteria
April 3, 2007
First Posted (Estimate)
April 4, 2007
Study Record Updates
Last Update Posted (Estimate)
May 25, 2011
Last Update Submitted That Met QC Criteria
May 24, 2011
Last Verified
May 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DK66759 (completed)
- R01DK066759 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.