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

ClinicalTrials.gov processed this record on April 21, 2014