|
|
View Clinical Trial (Medical Research Study)
|
Effects of Worksite Wellness Interventions on Vascular Function, Insulin Sensitivity and High-Density Lipoprotein in Overweight or Obese Women - NCT00666172-20892 (Clinical Trial 217439)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy217439.aspx
|
** Please review additional "Nearby Studies" on right ----->
|
|
 |
 |
|
| City: |
|
Bethesda |
|
State:
|
|
MD |
| Zip Code: |
|
20892 |
| Conditions: |
|
Atherosclerosis - Diabetes Mellitus - Obesity - Dyslipidemia - Hypertension |
| Purpose: |
|
Employees in developed societies are becoming increasingly sedentary at work and at home due
to technological advances. Physical inactivity coupled with excess intake of calorie-rich
foods are responsible for the epidemic of obesity. In population cohorts, physical
inactivity and obesity increase the risk of cardiovascular disease and death. Because of the
impact on productivity and health care costs, many businesses and other organizations have
initiated "wellness" programs, often with facilities at the work site to encourage exercise.
Although these programs have often resulted in improved fitness for participants, weight
loss has been more difficult to achieve. In this regard, in our initial study of NIH
employees participating in NHLBI's Keep the Beat program--two-thirds of whom were overweight
or obese--we found improved exercise fitness after 3 months of participation, with exercise
averaging 20 minutes each work day, but no significant weight loss. Associated with greater
fitness in our participants was improvement in endothelial function, an important biomarker
of cardiovascular risk. Because level of fitness is a strong predictor of cardiovascular
(and total) mortality in population studies, some investigators and thought leaders have
proposed that it is acceptable to be "fat and fit." We found in our study, however, that
exercise alone has little effect on insulin sensitivity and other biomarkers of risk,
including C-reactive protein, which could limit further improvement in endothelial function
and even greater risk reduction. We propose to test in this protocol whether weight loss
through supervised nutritional counseling and daily exercise at worksite facilities confers
health benefits beyond those achieved with improved fitness alone, such as improvement in
endothelial function, arterial compliance, insulin sensitivity, markers of inflammation in
blood and high-density lipoprotein (HDL) structure and function. Because obesity in a
sedentary workforce environment is especially prevalent among women, with additional
contribution of menopause to obesity, our study will be restricted to overweight and obese
women to allow appropriate analysis in a cohort of manageable size for our testing
resources. The primary endpoint will be differential improvement in endothelial function, as
determined by brachial artery reactivity to shear stress, from baseline to 6 months in
participants randomized to exercise coupled with weight-loss intervention versus subjects
randomized to exercise alone. Secondary analyses will include comparisons of adiposity,
arterial stiffness, insulin sensitivity, HDL subparticles and function, and markers of
inflammation and adipokines in blood, with exploratory analyses of minorities and
age/hormonal interactions. Demonstration of improved vascular function and other biomarkers
of cardiovascular risk with improved fitness combined with weight loss may serve as an
incentive for greater participation in organization-initiated wellness programs with
emphasis both on exercise and on personalized nutritional counseling.
|
| Study summary: |
|
Employees in developed societies are becoming increasingly sedentary at work and at home due
to technological advances. Physical inactivity coupled with excess intake of calorie-rich
foods are responsible for the epidemic of obesity. In population cohorts, physical
inactivity and obesity increase the risk of cardiovascular disease and death. Because of the
impact on productivity and health care costs, many businesses and other organizations have
initiated "wellness" programs, often with facilities at the work site to encourage exercise.
Although these programs have often resulted in improved fitness for participants, weight
loss has been more difficult to achieve. In this regard, in our initial study of NIH
employees participating in NHLBI's Keep the Beat program--two-thirds of whom were overweight
or obese--we found improved exercise fitness after 3 months of participation, with exercise
averaging 20 minutes each work day, but no significant weight loss. Associated with greater
fitness in our participants was improvement in endothelial function, an important biomarker
of cardiovascular risk. Because level of fitness is a strong predictor of cardiovascular
(and total) mortality in population studies, some investigators and thought leaders have
proposed that it is acceptable to be "fat and fit." We found in our study, however, that
exercise alone has little effect on insulin sensitivity and other biomarkers of risk,
including C-reactive protein, which could limit further improvement in endothelial function
and even greater risk reduction. We propose to test in this protocol whether weight loss
through supervised nutritional counseling and daily exercise at worksite facilities confers
health benefits beyond those achieved with improved fitness alone, such as improvement in
endothelial function, arterial compliance, insulin sensitivity, markers of inflammation in
blood and high-density lipoprotein (HDL) structure and function. Because obesity in a
sedentary workforce environment is especially prevalent among women, with additional
contribution of menopause to obesity, our study will be restricted to overweight and obese
women to allow appropriate analysis in a cohort of manageable size for our testing
resources. The primary endpoint will be differential improvement in endothelial function, as
determined by brachial artery reactivity to shear stress, from baseline to 6 months in
participants randomized to exercise coupled with weight-loss intervention versus subjects
randomized to exercise alone. Secondary analyses will include comparisons of adiposity,
arterial stiffness, insulin sensitivity, HDL subparticles and function, and markers of
inflammation and adipokines in blood, with exploratory analyses of minorities and
age/hormonal interactions. Demonstration of improved vascular function and other biomarkers
of cardiovascular risk with improved fitness combined with weight loss may serve as an
incentive for greater participation in organization-initiated wellness programs with
emphasis both on exercise and on personalized nutritional counseling. |
| Criteria: |
|
- INCLUSION CRITERIA:
1. Female employees of NIH who are not currently participating or greater than 3
months from participation in the Keep the Beat program or other structured
exercise or weight-loss program (e.g., Weight Watchers, NutriSystems,
personalized nutritional counseling or fitness trainers), and have not undergone
weight loss (bariatric) surgery. Self-directed exercise (walks around the block,
climbing stairs) is acceptable for inclusion, with subjects encouraged to
continue such activity, in addition to worksite exercise, throughout the
program.
2. Body-mass index greater than or equal to 25 kg/m(2).
3. Subject understands protocol and provides written, informed consent in addition
to willingness to comply with specified follow-up evaluations.
EXCLUSION CRITERIA:
1. Medical condition, including recent unintentional weight loss, that might prohibit
safe participation in the Keep the Beat program.
2. Fluctuation in weight greater than 5 percent over previous 3 months by self report.
3. Fasting blood glucose greater than or equal to 126 mg/dL in absence of prior
diagnosis of diabetes mellitus.
4. Weight greater than 200 kg (exceeds capacity of DXA scanner).
5. Heart disease as indicated by history of myocardial infarction, documented disease on
coronary angiography, coronary artery stent placement, congestive heart failure,
significant structural heart disease (e.g. hypertrophic or dilated cardiomyopathy,
valvular heart disease).
6. Hyper- or hypothyroid by routine lab screening.
7. Physically unable to perform the Keep the Beat program due to neurologic or
orthopedic conditions.
8. Pregnant women due to large hormonal changes in pregnancy that affect study variables
and potential pregnancy-related restrictions on exercise.
9. Participation in another study protocol which includes blood draws or interventions.
10. Use of medications that might interfere with, or promote, weight loss. |
|
|
|
| Study is available at: |
|
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, MD 20892
United States
Primary Contact:
Patient Recruitment and Public Liaison Office
Email: prpl@mail.cc.nih.gov
Phone: (800) 411-1222 |
|
|
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
|
| Trials Alerts: |
|
If you would like to be
notified of new clinical trials as they become available please
register for a free account.
|
|
| Data Source: |
|
ClinicalTrials.gov |
| Date Processed: |
|
November 16, 2009 |
Modifications to
this listing: |
|
Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
|
| |
|
|
| |
|
|
| |
|
|
| |
|
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
|
|
|
|
|
|
|
|