Effect of Weight Loss on Cardiovascular Disease Risk Factors in Obese Women
Primary Purpose
Obesity, Cardiovascular Diseases
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Diet
Diet Plus Aerobic Training
Diet plus Resistance Training
Sponsored by
About this trial
This is an interventional prevention trial for Obesity focused on measuring Intervention Studies, Magnetic Resonance Imaging, C-Reactive Protein
Eligibility Criteria
Inclusion Criteria:
- Female
- 30-55 years of age
- BMI = 35.0-44.9 kg/m2
Exclusion Criteria:
- Currently pregnant, pregnant in the past 6 months, or planning on becoming pregnant in the next 6 months.
- Regularly exercising for greater than 60 minutes per week.
- Taking prescription or over-the-counter medications that affect body weight, metabolism, blood pressure, or heart rate, such as psychotropic medications (e.g. zoloft, prozac, paxil, xanax) and medications that have metabolic effects (e.g. synthroid, wellbutrin, metformin).
- Having physical limitations that hinder or prevent exercise.
- Currently being treated for coronary heart disease, diabetes mellitus, hypertension, or cancer.
- Having a resting systolic blood pressure of > 150mmHg of diastolic blood pressure of > 100mmHg or currently taking any medications that affect blood pressure or heart rate (i.e. beta blockers).
- Currently enrolled in an exercise or weight control study or participating in an exercise or weight control study in the past 6 months.
- Have lost and not regained > 5% body weight in the past 6 months.
- Currently being treated for any psychological problems or taking any psychotropic medications.
- Abnormal kidney functions, as per current institutional standard for gadolinium administration.
- Known allergy to IV gadolinium, or the discovery of an allergic reaction to IV gadolinium at baseline.
Sites / Locations
- Physical Activity and Weight Management Research Center, Suite 600 Birmingham Towers
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Diet Only
Diet plus Aerobic Training
Diet plus Resistance Training
Arm Description
Outcomes
Primary Outcome Measures
Cardiovascular Disease Risk Factors
Inflammation as determined by C-Reactive Protein and Cardiac Structure and Function as defined by left ventricular mass, aortic pulse wave velocity, fibrosis, and ejection fraction.
Secondary Outcome Measures
Weight Loss
Weight loss by diet alone, diet plus aerobic training, and diet plus resistance training.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01353001
Brief Title
Effect of Weight Loss on Cardiovascular Disease Risk Factors in Obese Women
Official Title
The Effect of Weight Loss and Exercise on Cardiovascular Disease Risk Factors in Class II and III Obese Women
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
July 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pittsburgh
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to examine the effect of weight loss and exercise on cardiovascular disease risk factors, specifically inflammation as measured by C-Reactive Protein and cardiac structure and function as measured by cardiac MRI, in Class II and III obese women during a 12 week training intervention.
Detailed Description
To date, research investigating obesity, inflammation, and cardiovascular disease has utilized lifestyle interventions focused on weight loss and exercise among groups with BMI classifications of normal, overweight and mildly obese. A limitation of recent investigations is the failure to utilize participants who are significantly overweight. Those whose BMI classification extends to Class II and Class III obesity (BMI > 35.0, and BMI > 40.0) have not yet been studied at length, yet these individuals have been shown to be able to substantially improve their cardiovascular risk profiles without attaining a BMI below 25. Inactivity has been linked to increased adiposity and a trend toward higher levels of cardiovascular disease risk. It is necessary to study the relationships between weight loss and weight loss with added physical activity among Class II and Class III obese participants in order to gain a more thorough knowledge of the effects of BMI on circulating markers of inflammation and the cardiac structural and functional changes associated with weight loss among this population. A second limitation of the current research is the use of strictly progressive resistance training protocols. The protocols used have increased constantly in intensity or volume, if not both. Constant increases in intensity tend to lead to overtraining among participants, highlighting a need for more variation of intensity and volume in the training protocol in order to avoid stagnation and overtraining. Finally, no research has studied the specific impact of diet and resistance training on either CRP or cardiovascular adaptations.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Cardiovascular Diseases
Keywords
Intervention Studies, Magnetic Resonance Imaging, C-Reactive Protein
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Diet Only
Arm Type
Experimental
Arm Title
Diet plus Aerobic Training
Arm Type
Experimental
Arm Title
Diet plus Resistance Training
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Diet
Intervention Description
Participants will be given a calorie and fat gram goal according to their initial bodyweight. The fat gram goals will be set at 20% to 30% of total caloric intake. Subject calorie and fat gram goals are as follows: Subjects weighing less than 175 pounds will receive a diet prescription of 1200 calories and 27 fat grams per day. Subjects weighing between 175 and 219 pounds will receive a diet prescription of 1500 calories and 33 fat grams per day. Subjects weighing between 220 and 249 pounds will receive a diet prescription of 1800 calories and 40 fat grams per day. Subjects weighing greater than 250 pounds will receive a diet prescription of 2100 calories and 47 fat grams per day.
Intervention Type
Behavioral
Intervention Name(s)
Diet Plus Aerobic Training
Other Intervention Name(s)
DIET+AT
Intervention Description
Participants will receive all of the components as described for the DIET group. Additionally, this group will participate in supervised progressive aerobic training 3 days per week. Participants will be required to attend 3 sessions per week where they will participate in supervised exercise sessions progressing from 60 to 180 minutes per week of moderate-intensity (3.0-6.0 METS) aerobic exercise. 180 minutes per week of exercise will meet the American College of Sports Medicine and the American Heart Association recommendations of 450-750 METS.min.wk-1.
Intervention Type
Behavioral
Intervention Name(s)
Diet plus Resistance Training
Other Intervention Name(s)
DIET+RT
Intervention Description
Participants will receive all of the components as the DIET group. Participants will also participate in supervised resistance training protocol 3 days per week in the form of an individual session. The protocol will start the participants at a low volume of exercise at an intensity of 50-55% of 1-repetition maximum, and oscillate in both volume and intensity during the intervention, with a general trend toward increases in intensity as outlined in the ACSM Position Stand.
Primary Outcome Measure Information:
Title
Cardiovascular Disease Risk Factors
Description
Inflammation as determined by C-Reactive Protein and Cardiac Structure and Function as defined by left ventricular mass, aortic pulse wave velocity, fibrosis, and ejection fraction.
Time Frame
0 and 12 weeks
Secondary Outcome Measure Information:
Title
Weight Loss
Description
Weight loss by diet alone, diet plus aerobic training, and diet plus resistance training.
Time Frame
0 and 12 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Female
30-55 years of age
BMI = 35.0-44.9 kg/m2
Exclusion Criteria:
Currently pregnant, pregnant in the past 6 months, or planning on becoming pregnant in the next 6 months.
Regularly exercising for greater than 60 minutes per week.
Taking prescription or over-the-counter medications that affect body weight, metabolism, blood pressure, or heart rate, such as psychotropic medications (e.g. zoloft, prozac, paxil, xanax) and medications that have metabolic effects (e.g. synthroid, wellbutrin, metformin).
Having physical limitations that hinder or prevent exercise.
Currently being treated for coronary heart disease, diabetes mellitus, hypertension, or cancer.
Having a resting systolic blood pressure of > 150mmHg of diastolic blood pressure of > 100mmHg or currently taking any medications that affect blood pressure or heart rate (i.e. beta blockers).
Currently enrolled in an exercise or weight control study or participating in an exercise or weight control study in the past 6 months.
Have lost and not regained > 5% body weight in the past 6 months.
Currently being treated for any psychological problems or taking any psychotropic medications.
Abnormal kidney functions, as per current institutional standard for gadolinium administration.
Known allergy to IV gadolinium, or the discovery of an allergic reaction to IV gadolinium at baseline.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven D Verba, MS
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Blake D Justice, MS
Organizational Affiliation
University of Pittsburgh
Official's Role
Study Director
Facility Information:
Facility Name
Physical Activity and Weight Management Research Center, Suite 600 Birmingham Towers
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15203
Country
United States
12. IPD Sharing Statement
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Effect of Weight Loss on Cardiovascular Disease Risk Factors in Obese Women
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