Methods of Weight Loss in Overweight Coronary Patients

Obesity Clinical Trial

Official title:

Methods of Weight Loss in Overweight Coronary Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00628277
• Other study ID #: 03-049
• Status: Completed
• Phase: Phase 3
• First received: February 26, 2008
• Last updated: February 26, 2008
• Start date: October 2002
• Est. completion date: July 2007

Study information

• Verified date: February 2008
• Source: University of Vermont
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: July 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 90 Years

Eligibility

Inclusion Criteria:

• Coronary heart disease

• BMI > 27

• Peak Vo2 > 14.4 ml/kg/min

Exclusion Criteria:

• Presence of diabetes

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity
• Weight Loss

Intervention

Behavioral:
• high caloric expenditure exercise
high caloric expenditure exercise plus dietary counseling
• low caloric expenditure exercise plus dietary counseling
low caloric expenditure exercise plus dietary counseling

Locations

Country	Name	City	State
United States	University of Vermont College of Medicine	Burlington	Vermont

Sponsors (1)

Lead Sponsor	Collaborator
University of Vermont

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fat Mass		4 months, 12 months	No
Secondary	Intrabdominal (visceral) fat		4 months	No
Secondary	Insulin stimulated glucose disposal		4 months	No