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Methods of Weight Loss in Overweight Coronary Patients

This study has been completed.
Sponsor:
Information provided by:
University of Vermont
ClinicalTrials.gov Identifier:
NCT00628277
First received: February 26, 2008
Last updated: NA
Last verified: February 2008
History: No changes posted
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Intrabdominal (visceral) fat [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Insulin stimulated glucose disposal [ Time Frame: 4 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   21 Years to 90 Years
Genders Eligible for Study:   Both
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
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: 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

No publications provided by University of Vermont

Additional 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
Study First Received: February 26, 2008
Last Updated: February 26, 2008
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Obesity
Overweight
Weight Loss
Body Weight
Body Weight Changes
Nutrition Disorders
Overnutrition
Signs and Symptoms

ClinicalTrials.gov processed this record on November 25, 2014