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Enhancing Support for Women at Risk for Heart Disease

This study has been completed.
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Oregon Research Institute Identifier:
First received: September 1, 2005
Last updated: February 4, 2016
Last verified: February 2016
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 Intervention
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

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Prevention

Resource links provided by NLM:

Further study details as provided by Oregon Research Institute:

Study Start Date: April 1999
Study Completion Date: March 2005
Primary Completion Date: September 2004 (Final data collection date for primary outcome measure)
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).


Ages Eligible for Study:   up to 100 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
No eligibility criteria
  Contacts and Locations
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Please refer to this study by its identifier: NCT00142701

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

Responsible Party: Oregon Research Institute Identifier: NCT00142701     History of Changes
Other Study ID Numbers: 251
R01HL062156 ( US NIH Grant/Contract Award Number )
Study First Received: September 1, 2005
Last Updated: February 4, 2016
Individual Participant Data  
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Diabetes Mellitus
Cardiovascular Diseases
Heart 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 processed this record on May 25, 2017