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NCT00005441 Clinical Trial

Lifestyle Management for Women With CHD and NIDDM

Cardiovascular Diseases Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00005441
Other study ID # 4370
Secondary ID R29HL050181
Status Completed
Phase N/A
First received May 25, 2000
Last updated February 4, 2016
Start date April 1993
Est. completion date March 1998

Study information
Verified date February 2016
Source Oregon Research Institute
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date March 1998
Est. primary completion date October 1997
Accepts healthy volunteers No
Gender Female
Age group N/A to 100 Years
Eligibility No eligibility criteria

Study Design

N/A

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Oregon Research Institute National Heart, Lung, and Blood Institute (NHLBI)

References & Publications (1)

Toobert DJ, Glasgow RE, Nettekoven LA, Brown JE. Behavioral and psychosocial effects of intensive lifestyle management for women with coronary heart disease. Patient Educ Couns. 1998 Nov;35(3):177-88. — View Citation

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