Status:
COMPLETED
Effects of Worksite Wellness Interventions on Vascular Function, Insulin Sensitivity and High-Density Lipoprotein in Overweight or Obese Women
Lead Sponsor:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Atherosclerosis
Diabetes Mellitus
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief 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 respons...
Detailed Description
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 respons...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- 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.
- Body-mass index greater than or equal to 25 kg/m(2).
- Subject understands protocol and provides written, informed consent in addition to willingness to comply with specified follow-up evaluations.
- EXCLUSION CRITERIA:
- Medical condition, including recent unintentional weight loss, that might prohibit safe participation in the Keep the Beat program.
- Fluctuation in weight greater than 5 percent over previous 3 months by self report.
- Fasting blood glucose greater than or equal to 126 mg/dL in absence of prior diagnosis of diabetes mellitus.
- Weight greater than 200 kg (exceeds capacity of DXA scanner).
- 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).
- Hyper- or hypothyroid by routine lab screening.
- Physically unable to perform the Keep the Beat program due to neurologic or orthopedic conditions.
- Pregnant women due to large hormonal changes in pregnancy that affect study variables and potential pregnancy-related restrictions on exercise.
- Participation in another study protocol which includes blood draws or interventions.
- Use of medications that might interfere with, or promote, weight loss.
Exclusion
Key Trial Info
Start Date :
April 8 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
270 Patients enrolled
Trial Details
Trial ID
NCT00666172
Start Date
April 8 2008
End Date
November 1 2012
Last Update
December 17 2019
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892