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Methods of Weight Loss in Overweight Coronary Patients

Primary Purpose

Obesity

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
high caloric expenditure exercise
low caloric expenditure exercise plus dietary counseling
Sponsored by
University of Vermont
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Obesity, coronary heart disease, coronary risk factors, weight loss, exercise

Eligibility Criteria

21 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Presence of diabetes

Sites / Locations

  • University of Vermont College of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Arm 1: high caloric expenditure exercise plus dietary counseling

Arm 2: low caloric expenditure exercise plus dietary counseling

Outcomes

Primary Outcome Measures

Fat Mass

Secondary Outcome Measures

Intrabdominal (visceral) fat
Insulin stimulated glucose disposal

Full Information

First Posted
February 26, 2008
Last Updated
February 26, 2008
Sponsor
University of Vermont
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1. Study Identification

Unique Protocol Identification Number
NCT00628277
Brief Title
Methods of Weight Loss in Overweight Coronary Patients
Official Title
Methods of Weight Loss in Overweight Coronary Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2008
Overall Recruitment Status
Completed
Study Start Date
October 2002 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
July 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Vermont

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Obesity, coronary heart disease, coronary risk factors, weight loss, exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Arm 1: high caloric expenditure exercise plus dietary counseling
Arm Title
2
Arm Type
Active Comparator
Arm Description
Arm 2: low caloric expenditure exercise plus dietary counseling
Intervention Type
Behavioral
Intervention Name(s)
high caloric expenditure exercise
Intervention Description
high caloric expenditure exercise plus dietary counseling
Intervention Type
Behavioral
Intervention Name(s)
low caloric expenditure exercise plus dietary counseling
Intervention Description
low caloric expenditure exercise plus dietary counseling
Primary Outcome Measure Information:
Title
Fat Mass
Time Frame
4 months, 12 months
Secondary Outcome Measure Information:
Title
Intrabdominal (visceral) fat
Time Frame
4 months
Title
Insulin stimulated glucose disposal
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Coronary heart disease BMI > 27 Peak Vo2 > 14.4 ml/kg/min Exclusion Criteria: Presence of diabetes
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip A Ades, MD
Organizational Affiliation
University of Vermont
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Vermont College of Medicine
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21778256
Citation
Ades PA, Savage PD, Lischke S, Toth MJ, Harvey-Berino J, Bunn JY, Ludlow M, Schneider DJ. The effect of weight loss and exercise training on flow-mediated dilatation in coronary heart disease: a randomized trial. Chest. 2011 Dec;140(6):1420-1427. doi: 10.1378/chest.10-3289. Epub 2011 Jul 21.
Results Reference
derived
PubMed Identifier
19433757
Citation
Ades PA, Savage PD, Toth MJ, Harvey-Berino J, Schneider DJ, Bunn JY, Audelin MC, Ludlow M. High-calorie-expenditure exercise: a new approach to cardiac rehabilitation for overweight coronary patients. Circulation. 2009 May 26;119(20):2671-8. doi: 10.1161/CIRCULATIONAHA.108.834184. Epub 2009 May 11.
Results Reference
derived

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Methods of Weight Loss in Overweight Coronary Patients

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