Weight Loss Maintenance in Primary Care

Obesity Clinical Trial

— PrimaryCare  

Official title:

Weight Loss Maintenance in Primary Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00455780
• Other study ID #: DK66759 (completed)
• Secondary ID: R01DK066759
• Status: Completed
• Phase: N/A
• First received: April 3, 2007
• Last updated: May 24, 2011
• Start date: January 2005
• Est. completion date: August 2010

Study information

• Verified date: May 2011
• Source: Drexel University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 238
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity
• Overweight
• Weight Loss

Intervention

Behavioral:
• Weight Loss Phase
Weight loss using CBT and meal replacements
• Continued CBT
Using CBT during weight loss maintenance
• reduced energy density education
Additional nutritional learning
• continued use of meal replacements
continued use of meal replacements during weight loss maintenance

Locations

Country	Name	City	State
United States	Drexel University	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Drexel University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight		baseline, 3 months, 12 months, 24 months, 36 months	No
Secondary	Body composition		baseline, 3 months, 12 months, 24 months, 36 months	No
Secondary	Blood work results		baseline, 3 months, 12 months, 24 months	No
Secondary	Scores on questionnaire-based measures		baseline, 3 months, 12 months, 24 months, 36 months	No