Enhancing Support for Women at Risk for Heart Disease

Study Description

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Brief Summary:

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 or disease	Intervention/treatment	Phase
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	Not Applicable

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).

Study Design

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Study Type :	Interventional (Clinical Trial)
Allocation:	Randomized
Primary Purpose:	Prevention
Study Start Date :	April 1999
Actual Primary Completion Date :	September 2004
Actual Study Completion Date :	March 2005

Arms and Interventions

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Outcome Measures

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Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	up to 100 Years (Child, Adult, Senior)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

No eligibility criteria

Contacts and Locations

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Sponsors and Collaborators

Oregon Research Institute

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

OverallOfficial:	Deborah Toobert	Oregon Research Institute

More Information

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Publications:

Toobert DJ, Strycker LA, Glasgow RE, Barrera M Jr, Angell K. Effects of the mediterranean lifestyle program on multiple risk behaviors and psychosocial outcomes among women at risk for heart disease. Ann Behav Med. 2005 Apr;29(2):128-37.

Glasgow RE, Toobert DJ, Barrera M Jr, Strycker LA. The Chronic Illness Resources Survey: cross-validation and sensitivity to intervention. Health Educ Res. 2005 Aug;20(4):402-9. Epub 2004 Nov 30.

Toobert DJ, Glasgow RE, Strycker LA, Barrera M Jr, Radcliffe JL, Wander RC, Bagdade JD. Biologic and quality-of-life outcomes from the Mediterranean Lifestyle Program: a randomized clinical trial. Diabetes Care. 2003 Aug;26(8):2288-93.

Toobert DJ, Strycker LA, Glasgow RE, Barrera M, Bagdade JD. Enhancing support for health behavior change among women at risk for heart disease: the Mediterranean Lifestyle Trial. Health Educ Res. 2002 Oct;17(5):574-85.

Toobert DJ, Strycker LA, Glasgow RE, Bagdade JD. If you build it, will they come?. Reach and Adoption associated with a comprehensive lifestyle management program for women with type 2 diabetes. Patient Educ Couns. 2002 Oct -Nov;48(2):99-105.

Responsible Party:	Oregon Research Institute
ClinicalTrials.gov Identifier:	NCT00142701 History of Changes
Other Study ID Numbers:	251; R01HL062156 ( U.S. NIH Grant/Contract )
First Posted:	September 2, 2005
Last Update Posted:	February 8, 2016
Last Verified:	February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Undecided

Additional relevant MeSH terms:

Heart Diseases; Diabetes Mellitus; Cardiovascular Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Diabetes Mellitus, Type 2	Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases