Lifestyle Management for Women With CHD and NIDDM

NCT ID: NCT00005441

Last Updated: 2016-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Study Classification

OBSERVATIONAL

Study Start Date

1993-04-30

Study Completion Date

1998-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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

Eligibility Criteria

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Inclusion Criteria

No eligibility criteria
Maximum Eligible Age

100 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

Oregon Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

References

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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. doi: 10.1016/s0738-3991(98)00074-3.

Reference Type BACKGROUND
PMID: 9887850 (View on PubMed)

Other Identifiers

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R29HL050181

Identifier Type: NIH

Identifier Source: secondary_id

View Link

4370

Identifier Type: -

Identifier Source: org_study_id

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