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
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:
Obesity
Weight Loss
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on April 17, 2014