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Methods of Weight Loss in Overweight Coronary Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00628277
First Posted: March 5, 2008
Last Update Posted: March 5, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Vermont
  Purpose
We hypothesize that a combination of high-caloric expenditure exercise and behavioral weight loss counseling would lead to a greater loss of fat mass and a greater improvement in cardiometabolic risk factors that standard (lower caloric expenditure) cardiac rehabilitation exercise plus counseling.

Condition Intervention Phase
Obesity Behavioral: high caloric expenditure exercise Behavioral: low caloric expenditure exercise plus dietary counseling Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Methods of Weight Loss in Overweight Coronary Patients

Resource links provided by NLM:


Further study details as provided by University of Vermont:

Primary Outcome Measures:
  • Fat Mass [ Time Frame: 4 months, 12 months ]

Secondary Outcome Measures:
  • Intrabdominal (visceral) fat [ Time Frame: 4 months ]
  • Insulin stimulated glucose disposal [ Time Frame: 4 months ]

Enrollment: 74
Study Start Date: October 2002
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Arm 1: high caloric expenditure exercise plus dietary counseling
Behavioral: high caloric expenditure exercise
high caloric expenditure exercise plus dietary counseling
Active Comparator: 2
Arm 2: low caloric expenditure exercise plus dietary counseling
Behavioral: low caloric expenditure exercise plus dietary counseling
low caloric expenditure exercise plus dietary counseling

Detailed Description:

We hypothesize that a combination of high-caloric expenditure exercise and behavioral weight loss counseling would lead to a greater loss of fat mass and a greater improvement in cardiometabolic risk factors that standard (lower caloric expenditure) cardiac rehabilitation exercise plus counseling.

The study population consists of overweight (BMI >27) patients with established coronary heart disease. The exercise and counseling program was of 4 months duration with extended follow up at 1 year.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Coronary heart disease
  • BMI > 27
  • Peak Vo2 > 14.4 ml/kg/min

Exclusion Criteria:

  • Presence of diabetes
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00628277


Locations
United States, Vermont
University of Vermont College of Medicine
Burlington, Vermont, United States, 05401
Sponsors and Collaborators
University of Vermont
Investigators
Principal Investigator: Philip A Ades, MD University of Vermont
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Principal Investigator: Philip Ades MD, Professor of Medicine, University of Vermont college of Medicine
ClinicalTrials.gov Identifier: NCT00628277     History of Changes
Other Study ID Numbers: 03-049
First Submitted: February 26, 2008
First Posted: March 5, 2008
Last Update Posted: March 5, 2008
Last Verified: February 2008

Keywords provided by University of Vermont:
Obesity
coronary heart disease
coronary risk factors
weight loss
exercise

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