Weight Loss Maintenance in Primary Care (PrimaryCare)

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Drexel University
ClinicalTrials.gov Identifier:
NCT00455780
First received: April 3, 2007
Last updated: May 24, 2011
Last verified: May 2011
  Purpose

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.


Condition Intervention
Obesity
Overweight
Behavioral: Weight Loss Phase
Behavioral: Continued CBT
Behavioral: reduced energy density education
Behavioral: continued use of meal replacements

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Weight Loss Maintenance in Primary Care

Resource links provided by NLM:


Further study details as provided by Drexel University:

Primary Outcome Measures:
  • Weight [ Time Frame: baseline, 3 months, 12 months, 24 months, 36 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Body composition [ Time Frame: baseline, 3 months, 12 months, 24 months, 36 months ] [ Designated as safety issue: No ]
  • Blood work results [ Time Frame: baseline, 3 months, 12 months, 24 months ] [ Designated as safety issue: No ]
  • Scores on questionnaire-based measures [ Time Frame: baseline, 3 months, 12 months, 24 months, 36 months ] [ Designated as safety issue: No ]

Enrollment: 238
Study Start Date: January 2005
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MR-/REDE-
Weight Loss through cognitive behavioral therapy and meal replacement use, and continued therapy for weight loss maintenance.
Behavioral: Weight Loss Phase
Weight loss using CBT and meal replacements
Behavioral: Continued CBT
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.
Behavioral: Weight Loss Phase
Weight loss using CBT and meal replacements
Behavioral: Continued CBT
Using CBT during weight loss maintenance
Behavioral: continued use of meal replacements
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.
Behavioral: Weight Loss Phase
Weight loss using CBT and meal replacements
Behavioral: Continued CBT
Using CBT during weight loss maintenance
Behavioral: reduced energy density education
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.
Behavioral: Weight Loss Phase
Weight loss using CBT and meal replacements
Behavioral: Continued CBT
Using CBT during weight loss maintenance
Behavioral: reduced energy density education
Additional nutritional learning
Behavioral: continued use of meal replacements
continued use of meal replacements during weight loss maintenance

  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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Pennsylvania
Drexel University
Philadelphia, Pennsylvania, United States, 19102
Sponsors and Collaborators
Drexel University
Investigators
Principal Investigator: Michael R Lowe, PhD Drexel University
  More Information

No publications provided

Responsible Party: Michael R. Lowe, Ph.D., Drexel University
ClinicalTrials.gov Identifier: NCT00455780     History of Changes
Other Study ID Numbers: DK66759 (completed), R01DK066759
Study First Received: April 3, 2007
Last Updated: May 24, 2011
Health Authority: United States: Federal Government

Keywords provided by Drexel University:
Eating
Dieting
Meal replacements
Energy Density
Weight Loss Maintenance

Additional relevant MeSH terms:
Overweight
Weight Loss
Body Weight
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on September 16, 2014