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OpenTrials
Completed

NCT Number: NCT00628277

Methods of Weight Loss in Overweight Coronary Patients

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.

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Key information

Conditions

Obesity Behavior Body Weight Body Weight Changes Cardiovascular Diseases Coronary Disease Heart Diseases Motor Activity Myocardial Ischemia Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases Weight Loss

Age range

21 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Vermont College of Medicine

Burlington, Vermont, 05401, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Presence of diabetes

Treatment and study plan

high caloric expenditure exercise

Behavioral

high caloric expenditure exercise plus dietary counseling

low caloric expenditure exercise plus dietary counseling

Behavioral

low caloric expenditure exercise plus dietary counseling

Primary outcomes

  1. Fat Mass

    Time frame: 4 months, 12 months

Secondary outcomes

  1. Intrabdominal (visceral) fat

    Time frame: 4 months

  2. Insulin stimulated glucose disposal

    Time frame: 4 months

Sponsors and collaborators

Lead sponsor

University of Vermont

Other

Registry information

Important dates

Study start
2002
Primary completion
2007
Study completion
2007
First posted
Mar 5, 2008
Registry last updated
Mar 5, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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