Weight Loss Maintenance in Primary Care (PrimaryCare)

After a three month weight loss phase involving the use of meal replacements, participants are randomised 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.

Official Title

Weight Loss Maintenance in Primary Care

Conditions

• Obesity
• Overweight

Study Type

Interventional

Study Design

 

Treatment, Randomised, Open Label, Active Control, Factorial Assignment, Efficacy Study

Further Details

Primary Outcome Measures:

• Weight

Secondary Outcome Measures:

• Body composition
• Blood work results
• Scores on questionnaire-based measures

Study Start

January 2005

Eligibility & Criteria

Eligibility

• Ages Eligible for Study: 18 years to 70 years
• Genders Eligible for Study: Both
• Accepts Healthy Volunteers: No

Criteria

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 bipolar, 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

Total Enrolment

238

Contact Details

Please refer to this study by its ClinicalTrials.gov identifier: NCT00455780

Locations

Drexel University      
Philadelphia, Pennsylvania
United States, 19102

Sponsors and Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

Principal Investigator:      

Michael R Lowe, PhD 
Drexel University