Weight Loss Maintenance in Primary Care (PrimaryCare)

Drexel University

Status: Completed

Conditions: Overweight; Obesity

Treatments: Behavioral: Continued CBT; Behavioral: continued use of meal replacements; Behavioral: reduced energy density education; Behavioral: Weight Loss Phase

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00455780

R01DK066759 (U.S. NIH Grant/Contract)

DK66759 (completed)

Details and patient eligibility

About

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.

Enrollment: 238 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

---

238 participants in 4 patient groups

MR-/REDE-

Experimental group

Description:

Weight Loss through cognitive behavioral therapy and meal replacement use, and continued therapy for weight loss maintenance.

Treatment:

Behavioral: Weight Loss Phase

Behavioral: Continued CBT

MR+/REDE-

Experimental group

Description:

Weight Loss through cognitive behavioral therapy and meal replacement use, and continued therapy and use of meal replacements for weight loss maintenance.

Treatment:

Behavioral: Weight Loss Phase

Behavioral: continued use of meal replacements

Behavioral: Continued CBT

MR-/REDE+

Experimental group

Description:

Weight Loss through cognitive behavioral therapy and meal replacement use, and continued therapy as well as Reduced Energy Density Education for weight loss maintenance.

Treatment:

Behavioral: reduced energy density education

Behavioral: Weight Loss Phase

Behavioral: Continued CBT

MR+/REDE+

Experimental group

Description:

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.

Treatment:

Behavioral: reduced energy density education

Behavioral: Weight Loss Phase

Behavioral: continued use of meal replacements

Behavioral: Continued CBT