Methods of Weight Loss in Overweight Coronary Patients

February 26, 2008 updated by: University of Vermont
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

74

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Vermont
      • Burlington, Vermont, United States, 05401
        • University of Vermont College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Presence of diabetes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Fat Mass
Time Frame: 4 months, 12 months
4 months, 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Intrabdominal (visceral) fat
Time Frame: 4 months
4 months
Insulin stimulated glucose disposal
Time Frame: 4 months
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Vermont

Investigators

  • Principal Investigator: Philip A Ades, MD, University of Vermont

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2002

Primary Completion (Actual)

July 1, 2007

Study Completion (Actual)

July 1, 2007

Study Registration Dates

First Submitted

February 26, 2008

First Submitted That Met QC Criteria

February 26, 2008

First Posted (Estimate)

March 5, 2008

Study Record Updates

Last Update Posted (Estimate)

March 5, 2008

Last Update Submitted That Met QC Criteria

February 26, 2008

Last Verified

February 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 03-049

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Obesity

Clinical Trials on high caloric expenditure exercise

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Rwanda

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe