Enhancing Support for Women at Risk for Heart Disease

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00142701
First received: September 1, 2005
Last updated: NA
Last verified: August 2005
History: No changes posted
  Purpose

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 National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: April 1999
Estimated Study Completion Date: March 2005
Detailed Description:

BACKGROUND:

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."

DESIGN NARRATIVE:

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).

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

No eligibility criteria

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00142701

Sponsors and Collaborators
Investigators
Investigator: Deborah Toobert Oregon Research Institute
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00142701     History of Changes
Other Study ID Numbers: 251
Study First Received: September 1, 2005
Last Updated: September 1, 2005
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on October 22, 2014