Weight Loss Maintenance in Primary Care
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Drexel University
- Enrollment
- 238
- Locations
- 2
- Primary Endpoint
- Weight
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Weight
Time Frame: baseline, 3 months, 12 months, 24 months, 36 months
Secondary Outcomes
- Body composition(baseline, 3 months, 12 months, 24 months, 36 months)
- Blood work results(baseline, 3 months, 12 months, 24 months)
- Scores on questionnaire-based measures(baseline, 3 months, 12 months, 24 months, 36 months)