ObesityNCT01353001
Effect of Weight Loss on Cardiovascular Disease Risk Factors in Obese Women
A study testing Diet, Diet Plus Aerobic Training and Diet plus Resistance Training in people with Obesity and Cardiovascular Diseases, run by University of Pittsburgh at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 55 years, women only
- Conditions the study is for
- Obesity, Cardiovascular Diseases
- What is being tested?
- Diet, Diet Plus Aerobic Training and Diet plus Resistance Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Jul 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female
- 30-55 years of age
- BMI = 35.0-44.9 kg/m2
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Physical Activity and Weight Management Research Center, Suite 600 Birmingham Towers
Pittsburgh, Pennsylvania, 15203
About this study
Official title: The Effect of Weight Loss and Exercise on Cardiovascular Disease Risk Factors in Class II and III Obese Women
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.
Read the 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.
- Conditions
- Obesity, Cardiovascular Diseases
- Being tested
- Diet, Diet Plus Aerobic Training, Diet plus Resistance Training
- Keywords
- Intervention Studies, Magnetic Resonance Imaging, C-Reactive Protein
- Medical subject headings
- Obesity, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DietBehavioural
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.
Diet Plus Aerobic TrainingBehavioural
Also called DIET+AT
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.
Diet plus Resistance TrainingBehavioural
Also called DIET+RT
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.
| Study group | Role | What they receive |
|---|---|---|
| Diet Only | Experimental | Not described Receives: Behavioral: Diet |
| Diet plus Aerobic Training | Experimental | Not described Receives: Behavioral: Diet Plus Aerobic Training |
| Diet plus Resistance Training | Experimental | Not described Receives: Behavioral: Diet plus Resistance Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0 and 12 weeks
Secondary outcomes (1)
Weight Loss
Weight loss by diet alone, diet plus aerobic training, and diet plus resistance training.
Measured: 0 and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2011 (estimated)
- Study startApr 2011
- Primary completionMay 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steven D Verba, MS, Principal investigator, University of PittsburghBlake D Justice, MS, Study director, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01353001
- Sponsor's protocol ID
- BSD-UPitt
- Status last verified
- Jan 2016
- First submitted
- 11 May 2011
- Last updated
- 5 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Weight Loss and Exercise on Cardiovascular Disease Risk Factors in Class II and III Obese Women
- ClinicalTrials.gov ID
- NCT01353001
- Acronym / sponsor ID
- BSD-UPitt
- Conditions
- Obesity, Cardiovascular Diseases
- Keywords
- Intervention Studies, Magnetic Resonance Imaging, C-Reactive Protein
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- May 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 12 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Diet Only | Experimental | Behavioral: Diet |
| Diet plus Aerobic Training | Experimental | Behavioral: Diet Plus Aerobic Training |
| Diet plus Resistance Training | Experimental | Behavioral: Diet plus Resistance Training |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Female
- 30-55 years of age
- BMI = 35.0-44.9 kg/m2
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DietParticipants 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. | Behavioural | Diet Only |
| Diet Plus Aerobic TrainingAlso: DIET+ATParticipants 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. | Behavioural | Diet plus Aerobic Training |
| Diet plus Resistance TrainingAlso: DIET+RTParticipants 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. | Behavioural | Diet plus Resistance Training |
Primary outcome
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.
1 secondary outcome
Weight Loss
Time frame: 0 and 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven D Verba, MS principal investigator
University of Pittsburgh
Blake D Justice, MS study director
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet, Diet Plus Aerobic Training and Diet plus Resistance Training in people with Obesity and Cardiovascular Diseases, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular Disease Risk Factors (time frame: 0 and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2016.