Effect of Weight Loss on Cardiovascular Disease Risk Factors in Obese Women
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|ClinicalTrials.gov Identifier: NCT01353001|
Recruitment Status : Completed
First Posted : May 12, 2011
Last Update Posted : January 5, 2016
|Condition or disease||Intervention/treatment||Phase|
|Obesity Cardiovascular Diseases||Behavioral: Diet Behavioral: Diet Plus Aerobic Training Behavioral: Diet plus Resistance Training||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effect of Weight Loss and Exercise on Cardiovascular Disease Risk Factors in Class II and III Obese Women|
|Study Start Date :||April 2011|
|Actual Primary Completion Date :||May 2011|
|Actual Study Completion Date :||July 2011|
|Experimental: Diet Only||
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.
|Experimental: Diet plus Aerobic Training||
Behavioral: Diet Plus Aerobic Training
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.
Other Name: DIET+AT
|Experimental: Diet plus Resistance Training||
Behavioral: Diet plus Resistance Training
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.
Other Name: DIET+RT
- Cardiovascular Disease Risk Factors [ Time Frame: 0 and 12 weeks ]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.
- Weight Loss [ Time Frame: 0 and 12 weeks ]Weight loss by diet alone, diet plus aerobic training, and diet plus resistance training.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01353001
|United States, Pennsylvania|
|Physical Activity and Weight Management Research Center, Suite 600 Birmingham Towers|
|Pittsburgh, Pennsylvania, United States, 15203|
|Principal Investigator:||Steven D Verba, MS||University of Pittsburgh|
|Study Director:||Blake D Justice, MS||University of Pittsburgh|