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Enhancing Support for Women at Risk for Heart Disease

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ClinicalTrials.gov Identifier: NCT00142701
Recruitment Status : Completed
First Posted : September 2, 2005
Last Update Posted : February 8, 2016
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Oregon Research Institute

Brief Summary:
To test a practical, theory-based intervention to achieve long-term behavior change for postmenopausal women with Type 2 diabetes at high risk for developing coronary heart disease (CHD).

Condition or disease Intervention/treatment
Cardiovascular Diseases Heart Diseases Coronary Disease Coronary Heart Disease Risk Reduction Diabetes Mellitus, Non-insulin Dependent Behavioral: diet Behavioral: physical activity Behavioral: stress management Behavioral: smoking cessation

Detailed Description:


The overall goal of this study was to test a practical, theory-based intervention to achieve long-term behavior change for women with Type 2 diabetes at high risk for developing coronary heart disease (CHD). Epidemiological and clinical studies suggest that diabetes is associated with increased risk for CHD that is greater in women than in men. CHD is a major cause of death and functional limitations in women, but the vast majority of CHD studies have primarily involved middle-aged men. There is convincing research evidence that healthy lifestyle behaviors, including low-fat diet, physical activity, stress management, smoking cessation, and social support, can reduce CHD risk

The study was initiated in response to a Request for Applications released in October 1997 by the National Institutes of Health Office of the Director on "Innovative Approaches to Disease Prevention Through Behavior Change."


The study was a randomized trial to compare short-term (6-month) outcomes in women receiving usual care compared to a modified Ornish-type comprehensive lifestyle management (CLM) intervention. Participants (N = 279) were randomized to usual care (UC) or Mediterranean Lifestyle Program, a lifestyle change intervention aimed at the behavioral risk factors (eating patterns, physical activity, stress management, and social support) affecting risk for CHD in postmenopausal women with type 2 diabetes. After 6 months, women in the CLM condition were randomized to one of two approaches for providing support either lay-led group support or personalized computer-based support - to evaluate these strategies in enhancing longer-term maintenance of effects. Outcomes included multiple CHD lifestyle behaviors (e.g., dietary intake, exercise levels, stress management, smoking cessation), physiological risk factors associated with CHD (e.g., serum lipids, hypertension, weight, vascular reactivity), HbA1c (glycated hemoglobin, a measure of diabetes), and quality of life (e.g., depression, functioning).

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Primary Purpose: Prevention
Study Start Date : April 1999
Primary Completion Date : September 2004
Study Completion Date : March 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 100 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
No eligibility criteria

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00142701

Sponsors and Collaborators
Oregon Research Institute
National Heart, Lung, and Blood Institute (NHLBI)
OverallOfficial: Deborah Toobert Oregon Research Institute

Responsible Party: Oregon Research Institute
ClinicalTrials.gov Identifier: NCT00142701     History of Changes
Other Study ID Numbers: 251
R01HL062156 ( U.S. NIH Grant/Contract )
First Posted: September 2, 2005    Key Record Dates
Last Update Posted: February 8, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Heart Diseases
Diabetes Mellitus
Cardiovascular Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vascular Diseases
Arterial Occlusive Diseases