Cardiovascular DiseaseHeart HealthNCT01500356
Effect of Exercise and Weight Loss on Cardiovascular Health
A study testing Behavioral weight loss intervention, Diet Plus Moderate Exercise and Diet Plus High Exercise in people with Cardiovascular Disease and Obesity, run by University of Pittsburgh at 1 site in United States.
Trial summary
The primary aim of this study is to examine the effect of the consensus public health recommended level of physical activity [moderate physical activity (MOD-PA) = 150 min/wk] versus a higher dose of physical activity [high physical activity (HIGH-PA) = 250 min/wk] in the context of a comprehensive behavioral weight… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease, Obesity
- What is being tested?
- Behavioral weight loss intervention, Diet Plus Moderate Exercise and Diet Plus High Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 383 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Dec 2011to 30 Jun 2016
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-55 years of age.
- Body mass index (BMI) between 25.0 to <40.0 kg/m2.
- Ability to provide informed consent prior to participation in this study.
Who cannot join
- Females who are currently pregnant or breastfeeding, or reporting that she is planning a pregnancy within the next 12 months.
- History of bariatric surgery.
- Report current medical condition or treatment for a medical condition that could affect body weight. These may include the following: cancer (Note: Persons previously diagnosed with non-melanoma skin cancers, those successfully treated for cancer who have remained disease-free for five years or more would be eligible for participation in this study); diabetes mellitus; hyperthyroidism; inadequately controlled hypothyroidism; chronic renal insufficiency; chronic liver disease; gastrointestinal disorders including ulcerative colitis, Crohn's disease, or malabsorption syndromes; etc.
- Current congestive heart failure, angina, uncontrolled arrhythmia, symptoms indicative of an increased acute risk for a cardiovascular event, prior myocardial infarction, coronary artery bypass grafting or angioplasty, conditions requiring chronic anticoagulation (i.e. recent or recurrent DVT).
- Resting systolic blood pressure of >160 mmHg or resting diastolic blood pressure of >100 mmHg.
- Eating disorders that would contraindicate weight loss or physical activity.
Show all 11Show fewer
- Alcohol or substance abuse.
- Currently treated for psychological issues (i.e., depression, bipolar disorder, etc), taking psychotropic medications within the previous 12 months, or hospitalized for depression within the previous 5 years.
- Report exercise on >3 days per week for >20 minutes per day over the past 3 months. (NOTE: It is important that individuals are sedentary when entering this study to allow for maximal effect of the intervention.)
- Report weight loss of >5% or participating in a weight reduction diet in the past 3 months.
- Report plans to relocate to a location not accessible to the study site or having employment, personal, or travel commitments that prohibit attendance to at least 80 percent of the scheduled intervention sessions and all of the scheduled assessments.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15260
About this study
The primary aim of this study is to examine the effect of the consensus public health recommended level of physical activity [moderate physical activity (MOD-PA) = 150 min/wk] versus a higher dose of physical activity [high physical activity (HIGH-PA) = 250 min/wk] in the context of a comprehensive behavioral weight loss program that a includes a reduction in energy intake measures of cardiovascular function using cardiac MRI and biomarkers of vascular disease risk. Each of these exercise doses will be compared independently to a Diet Only group intervention on the proposed primary and secondary outcomes, with MOD-PA also compared to HIGH-PA. This study involves the recruitment of 390 overweight and obese adults who will be randomly assigned to one of the above conditions (Diet Only, MOD-PA, HIGH-PA) for a period of 12 months. The primary outcome is LVM measured by cardiac MRI. Secondary outcomes include additional cardiac MRI measures (aortic pulse wave velocity, end diastolic volume, aortic distensibility), inflammatory markers (CRP and TNFα) and selected adipocytokines (adiponectin) as biomarkers of risk related to vascular outcomes, body weight, body composition, and cardiorespiratory fitness, and traditional CVD risk factors (lipids, glucose, insulin, blood pressure). Additional secondary analyses will allow for examination of the effects of physical activity independent of weight change on the primary and secondary outcomes.
Read the detailed description
Current estimates indicate that in excess of 65 percent of adults in the United States are overweight (BMI >25.0 kg/m2) with at least 30 percent of adults classified as obese (BMI >30 kg/m2). Overweight and obesity have been linked to numerous chronic conditions including cardiovascular disease. The application of cardiac MRI (CMRI) allows for direct measurement of the cardiac structure, and left ventricular mass (LVM) assessed by CMRI has been shown to be predictive of cardiovascular disease. Recent studies have shown that LVM is decreased with weight loss; however, there is a lack of information on the added benefit of physical activity to weight loss on these direct measures of cardiovascular structure and function. Thus, consistent with PA-09-243, this study will examine the effect of two recommended doses of physical activity combined with a dietary intervention on changes in the proposed outcomes of cardiovascular disease risk in overweight adults.
The primary aim of this study is to examine the effect of the consensus public health recommended level of physical activity [moderate physical activity (MOD-PA) = 150 min/wk] versus a higher dose of physical activity [high physical activity (HIGH-PA) = 250 min/wk] in the context of a comprehensive behavioral weight loss program that a includes a reduction in energy intake measures of cardiovascular function using cardiac MRI and biomarkers of vascular disease risk. Each of these exercise doses will be compared independently to a Diet Only group intervention on the proposed primary and secondary outcomes, with MOD-PA also compared to HIGH-PA. This study involves the recruitment of 390 overweight and obese adults who will be randomly assigned to one of the above conditions (Diet Only, MOD-PA, HIGH-PA) for a period of 12 months. The primary outcome is LVM measured by cardiac MRI. Secondary outcomes include additional cardiac MRI measures (aortic pulse wave velocity, end diastolic volume, aortic distensibility), inflammatory markers (CRP and TNFα) and selected adipocytokines (adiponectin) as biomarkers of risk related to vascular outcomes, body weight, body composition, and cardiorespiratory fitness, and traditional CVD risk factors (lipids, glucose, insulin, blood pressure). Additional secondary analyses will allow for examination of the effects of physical activity independent of weight change on the primary and secondary outcomes.
- Conditions
- Cardiovascular Disease, Obesity
- Being tested
- Behavioral weight loss intervention, Diet Plus Moderate Exercise, Diet Plus High Exercise
- Keywords
- cardiovascular disease, obesity, exercise
- Medical subject headings
- Cardiovascular Diseases, Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral weight loss interventionBehavioural
Weight loss intervention that focuses on reducing energy intake.
Diet Plus Moderate ExerciseBehavioural
Weight loss intervention that involve an energy restricted diet (identical to the Diet Alone arm) plus the inclusion of 150 minutes per week of moderate-intensity exercise.
Diet Plus High ExerciseBehavioural
Weight loss intervention that involve an energy restricted diet (identical to the Diet Alone arm) plus the inclusion of 250-300 minutes per week of moderate-intensity exercise.
| Study group | Role | What they receive |
|---|---|---|
| Diet alone | Experimental | Weight loss intervention that focuses only on reducing energy intake of the diet. Receives: Behavioral: Behavioral weight loss intervention |
| Diet plus Moderate Exercise | Experimental | Weight loss intervention that involve an energy restricted diet (identical to the Diet Alone arm) plus the inclusion of 150 minutes per week of moderate-intensity exercise. Receives: Behavioral: Diet Plus Moderate Exercise |
| Diet Plus High Exercise | Experimental | Weight loss intervention that involve an energy restricted diet (identical to the Diet Alone arm) plus the inclusion of 250-300 minutes per week of moderate-intensity exercise. Receives: Behavioral: Diet Plus High Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Left ventricular mass assessed using cardiac MRI
Left ventricular mass will be assessed using cardiac MRI
Measured: Baseline (0 months) and 12 months
Secondary outcomes (10)
Change in end-diastolic volume assessed using cardiac MRI
Assessed using cardiac MRI
Measured: baseline (0 months) and 12 months
Change in cardiorespiratory fitness
Measured using a graded exercise test
Measured: baseline (0 months) 6 months, and 12 months
Change in blood levels of C-Reactive Protein (CRP)
Assessed from a fasting blood sample
Measured: baseline (0 months), 6 months, and 12 months
Change in body weight
Measured: baseline (0 months), 6 months, and 12 months
Change in body composition
Measured using dual-energy x-ray absorptiometry (DXA)
Measured: baseline (0 months), 6 months, and 12 months
Change in regional adiposity
Measured using anthromometry that includes girth measures of the waist and hip
Measured: baseline (0 months), 6 months, 12 months
Change in physical activity
Measured using both a wearable device and by questionnaire
Measured: baseline (0 months), 6 months, 12 months
Change in energy intake
Assessed using a questionnaire
Measured: baseline (0 months), 6 months, 12 months
Change in traditional CVD risk factors (lipids, glucose, insulin)
Measured from a fasting blood sample
Measured: baseline (0 months), 6 months, 12 months
Change in resting blood pressure
Measured: baseline (0 months), 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2011 (estimated)
- Study start13 Dec 2011
- Primary completion30 Jun 2016
- Study completion30 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseaseStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 383 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John M. Jakicic, PhD, University of Pittsburgh
- Investigators
- John M. Jakicic, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01500356
- Sponsor's protocol ID
- HL103646
- Acronym
- Heart Health
- Status last verified
- Jul 2017
- First submitted
- 22 Dec 2011
- Last updated
- 25 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jakicic JM, Rogers RJ, Lang W, Gibbs BB, Yuan N, Fridman Y, Schelbert EB. Impact of weight loss with diet or diet plus physical activity on cardiac magnetic resonance imaging and cardiovascular disease risk factors: Heart Health Study randomized trial. Obesity (Silver Spring). 2022 May;30(5):1039-1056. doi: 10.1002/oby.23412.
PubMed 35470972
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Exercise and Weight Loss on Cardiovascular Health
- ClinicalTrials.gov ID
- NCT01500356
- Acronym / sponsor ID
- Heart Health / HL103646
- Conditions
- Cardiovascular Disease, Obesity
- Keywords
- cardiovascular disease, obesity, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 383 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- 13 Dec 2011 (actual)
- Primary completion
- 30 Jun 2016 (actual)
- Study completion
- 30 Jun 2016 (actual)
- First posted
- 28 Dec 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 primary aim of this study is to examine the effect of the consensus public health recommended level of physical activity [moderate physical activity (MOD-PA) = 150 min/wk] versus a higher dose of physical activity [high physical activity (HIGH-PA) = 250 min/wk] in the context of a comprehensive behavioral weight loss program that a includes a reduction in energy intake measures of cardiovascular function using cardiac MRI and biomarkers of vascular disease risk. Each of these exercise doses will be compared independently to a Diet Only group intervention on the proposed primary and secondary outcomes, with MOD-PA also compared to HIGH-PA. This study involves the recruitment of 390 overweight and obese adults who will be randomly assigned to one of the above conditions (Diet Only, MOD-PA, HIGH-PA) for a period of 12 months. The primary outcome is LVM measured by cardiac MRI. Secondary outcomes include additional cardiac MRI measures (aortic pulse wave velocity, end diastolic volume, aortic distensibility), inflammatory markers (CRP and TNFα) and selected adipocytokines (adiponectin) as biomarkers of risk related to vascular outcomes, body weight, body composition, and cardiorespiratory fitness, and traditional CVD risk factors (lipids, glucose, insulin, blood pressure). Additional secondary analyses will allow for examination of the effects of physical activity independent of weight change on the primary and secondary outcomes.
Detailed description
Current estimates indicate that in excess of 65 percent of adults in the United States are overweight (BMI >25.0 kg/m2) with at least 30 percent of adults classified as obese (BMI >30 kg/m2). Overweight and obesity have been linked to numerous chronic conditions including cardiovascular disease. The application of cardiac MRI (CMRI) allows for direct measurement of the cardiac structure, and left ventricular mass (LVM) assessed by CMRI has been shown to be predictive of cardiovascular disease. Recent studies have shown that LVM is decreased with weight loss; however, there is a lack of information on the added benefit of physical activity to weight loss on these direct measures of cardiovascular structure and function. Thus, consistent with PA-09-243, this study will examine the effect of two recommended doses of physical activity combined with a dietary intervention on changes in the proposed outcomes of cardiovascular disease risk in overweight adults.
The primary aim of this study is to examine the effect of the consensus public health recommended level of physical activity [moderate physical activity (MOD-PA) = 150 min/wk] versus a higher dose of physical activity [high physical activity (HIGH-PA) = 250 min/wk] in the context of a comprehensive behavioral weight loss program that a includes a reduction in energy intake measures of cardiovascular function using cardiac MRI and biomarkers of vascular disease risk. Each of these exercise doses will be compared independently to a Diet Only group intervention on the proposed primary and secondary outcomes, with MOD-PA also compared to HIGH-PA. This study involves the recruitment of 390 overweight and obese adults who will be randomly assigned to one of the above conditions (Diet Only, MOD-PA, HIGH-PA) for a period of 12 months. The primary outcome is LVM measured by cardiac MRI. Secondary outcomes include additional cardiac MRI measures (aortic pulse wave velocity, end diastolic volume, aortic distensibility), inflammatory markers (CRP and TNFα) and selected adipocytokines (adiponectin) as biomarkers of risk related to vascular outcomes, body weight, body composition, and cardiorespiratory fitness, and traditional CVD risk factors (lipids, glucose, insulin, blood pressure). Additional secondary analyses will allow for examination of the effects of physical activity independent of weight change on the primary and secondary outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Diet alone | Experimental | Behavioral: Behavioral weight loss interventionWeight loss intervention that focuses only on reducing energy intake of the diet. |
| Diet plus Moderate Exercise | Experimental | Behavioral: Diet Plus Moderate ExerciseWeight loss intervention that involve an energy restricted diet (identical to the Diet Alone arm) plus the inclusion of 150 minutes per week of moderate-intensity exercise. |
| Diet Plus High Exercise | Experimental | Behavioral: Diet Plus High ExerciseWeight loss intervention that involve an energy restricted diet (identical to the Diet Alone arm) plus the inclusion of 250-300 minutes per week of moderate-intensity exercise. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 18-55 years of age.
- Body mass index (BMI) between 25.0 to <40.0 kg/m2.
- Ability to provide informed consent prior to participation in this study.
Key exclusion criteria (11 listed)
- Females who are currently pregnant or breastfeeding, or reporting that she is planning a pregnancy within the next 12 months.
- History of bariatric surgery.
- Report current medical condition or treatment for a medical condition that could affect body weight. These may include the following: cancer (Note: Persons previously diagnosed with non-melanoma skin cancers, those successfully treated for cancer who have remained disease-free for five years or more would be eligible for participation in this study); diabetes mellitus; hyperthyroidism; inadequately controlled hypothyroidism; chronic renal insufficiency; chronic liver disease; gastrointestinal disorders including ulcerative colitis, Crohn's disease, or malabsorption syndromes; etc.
- Current congestive heart failure, angina, uncontrolled arrhythmia, symptoms indicative of an increased acute risk for a cardiovascular event, prior myocardial infarction, coronary artery bypass grafting or angioplasty, conditions requiring chronic anticoagulation (i.e. recent or recurrent DVT).
- Resting systolic blood pressure of >160 mmHg or resting diastolic blood pressure of >100 mmHg.
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 |
|---|---|---|
| Behavioral weight loss interventionWeight loss intervention that focuses on reducing energy intake. | Behavioural | Diet alone |
| Diet Plus Moderate ExerciseWeight loss intervention that involve an energy restricted diet (identical to the Diet Alone arm) plus the inclusion of 150 minutes per week of moderate-intensity exercise. | Behavioural | Diet plus Moderate Exercise |
| Diet Plus High ExerciseWeight loss intervention that involve an energy restricted diet (identical to the Diet Alone arm) plus the inclusion of 250-300 minutes per week of moderate-intensity exercise. | Behavioural | Diet Plus High Exercise |
Primary outcome
Change in Left ventricular mass assessed using cardiac MRI
Time frame: Baseline (0 months) and 12 months
Left ventricular mass will be assessed using cardiac MRI
10 secondary outcomes
Change in end-diastolic volume assessed using cardiac MRI
Time frame: baseline (0 months) and 12 months
Change in cardiorespiratory fitness
Time frame: baseline (0 months) 6 months, and 12 months
Change in blood levels of C-Reactive Protein (CRP)
Time frame: baseline (0 months), 6 months, and 12 months
Change in body weight
Time frame: baseline (0 months), 6 months, and 12 months
Change in body composition
Time frame: baseline (0 months), 6 months, and 12 months
Change in regional adiposity
Time frame: baseline (0 months), 6 months, 12 months
Change in physical activity
Time frame: baseline (0 months), 6 months, 12 months
Change in energy intake
Time frame: baseline (0 months), 6 months, 12 months
Change in traditional CVD risk factors (lipids, glucose, insulin)
Time frame: baseline (0 months), 6 months, 12 months
Change in resting blood pressure
Time frame: baseline (0 months), 6 months, 12 months
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 25 Jul 2017.
- Derived from this study: PubMed 35470972Jakicic JM, Rogers RJ, Lang W, Gibbs BB, Yuan N, Fridman Y, Schelbert EB. Impact of weight loss with diet or diet plus physical activity on cardiac magnetic resonance imaging and cardiovascular disease risk factors: Heart Health Study randomized trial. Obesity (Silver Spring). 2022 May;30(5):1039-1056. doi: 10.1002/oby.23412.
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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.
John M. Jakicic, PhD principal investigator
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 Behavioral weight loss intervention, Diet Plus Moderate Exercise and Diet Plus High Exercise in people with Cardiovascular Disease and Obesity, 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 25 Jul 2017. 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?
Change in Left ventricular mass assessed using cardiac MRI (time frame: Baseline (0 months) and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01500356, which also lists 1 linked publication.
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 25 Jul 2017.