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Lifestyle Management for Women With CHD and NIDDM
This study has been completed.
First Received: May 25, 2000   Last Updated: June 23, 2005   History of Changes
Sponsored by: National Heart, Lung, and Blood Institute (NHLBI)
Information provided by: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT00005441
  Purpose

To develop and evaluate a comprehensive lifestyle self-management (CLSM) program (low-fat vegetarian diet, smoking cessation and stress management training) for postmenopausal women with coronary heart disease and Type II (non-insulin dependent) diabetes.


Condition
Cardiovascular Diseases
Coronary Disease
Heart Diseases
Diabetes Mellitus, Non-Insulin Dependent
Postmenopause
Diabetes Mellitus

MedlinePlus related topics: Coronary Artery Disease Diabetes Heart Disease in Women Heart Diseases
U.S. FDA Resources
Study Type: Observational
Study Design: Natural History, Longitudinal

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: April 1993
Estimated Study Completion Date: March 1998
Detailed Description:

BACKGROUND:

Coronary heart disease is the leading cause of death among postmenopausal women. Yet few studies have examined the potential for altering risk factors for coronary heart diseases among postmenopausal women, especially as a result of comprehensive lifestyle changes. A pressing need existed for controlled studies to evaluate the effects of comprehensive lifestyle changes on risks for coronary heart disease among postmenopausal women.

DESIGN NARRATIVE:

The comprehensive lifestyle management program appeared to produce substantial cardiovascular benefits among men but little was known about the behavioral processes through which change occurred. Its generalizability and applicability -- especially for high-risk women --was uncertain. The program was compared to a usual care condition in an initial randomized trial. Outcome measures included patient self-care behaviors and health outcomes (serum lipid profiles, blood pressure, relative weight, and glycemic control). Process measures included self-efficacy, personal health models, perceived stress, social support and problem-solving skills. Subjects participated in the intervention for three years, with gradual fading of the program in the third year to evaluate the long-term effects of the program. Analyses included assessments of between groups differences on physiological risk factors, behavioral (lifestyle) measures and process measures as well as maintenance over time. Based upon the results of this study, the long-term goal was to design a second outcome study in which the revised intervention would be evaluated with a larger sample to determine the relative contribution of adding moderate exercise and the effects on reversal of coronary heart disease.

  Eligibility

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

No eligibility criteria

  Contacts and Locations
No Contacts or Locations Provided
  More Information

Publications:
Study ID Numbers: 4370
Study First Received: May 25, 2000
Last Updated: June 23, 2005
ClinicalTrials.gov Identifier: NCT00005441     History of Changes
Health Authority: United States: Federal Government

Study placed in the following topic categories:
Arterial Occlusive Diseases
Heart Diseases
Metabolic Diseases
Myocardial Ischemia
Diabetes Mellitus
Vascular Diseases
Endocrine System Diseases
Ischemia
Arteriosclerosis
Coronary Disease
Diabetes Mellitus, Type 2
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder
Coronary Artery Disease

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

ClinicalTrials.gov processed this record on May 07, 2009