Enhancing Support for Women at Risk for Heart Disease

Cardiovascular Diseases Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00142701
• Other study ID #: 251
• Secondary ID: R01HL062156
• Status: Completed
• Phase: N/A
• First received: September 1, 2005
• Last updated: February 4, 2016
• Start date: April 1999
• Est. completion date: March 2005

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: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: March 2005
• Est. primary completion date: September 2004
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A to 100 Years
• Eligibility: No eligibility criteria

Study Design

Allocation: Randomized, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease Risk Reduction
• Diabetes Mellitus, Non-insulin Dependent
• Diabetes Mellitus, Type 2
• Heart Diseases
• Myocardial Ischemia

Intervention

Behavioral:
• diet

• physical activity

• stress management

• smoking cessation

Locations

Country	Name	City	State
n/a

Sponsors (2)

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

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

Toobert DJ, Strycker LA, Glasgow RE, Barrera Jr M, 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. — View Citation

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. — View Citation