Effect of Weight Loss on Cardiovascular Disease Risk Factors in Obese Women
|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.
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|