Enhancing Support for Women at Risk for Heart Disease

This study has been completed.

Sponsor:

Collaborator:

National Heart, Lung, and Blood Institute (NHLBI)

Information provided by (Responsible Party):

Oregon Research Institute

ClinicalTrials.gov Identifier:

NCT00142701

First received: September 1, 2005

Last updated: February 4, 2016

Last verified: February 2016

History of Changes

Purpose

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	Intervention
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


Study Type:	Interventional
Study Design:	Allocation: Randomized Primary Purpose: Prevention

Resource links provided by NLM:

MedlinePlus related topics: Heart Diseases

U.S. FDA Resources

Further study details as provided by Oregon Research Institute:


Study Start Date:	April 1999
Study Completion Date:	March 2005
Primary Completion Date:	September 2004 (Final data collection date for primary outcome measure)

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).

Eligibility


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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00142701

Sponsors and Collaborators

Oregon Research Institute

National Heart, Lung, and Blood Institute (NHLBI)

Investigators


OverallOfficial:	Deborah Toobert	Oregon Research Institute

More Information

Publications:

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.

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 )
Study First Received:	September 1, 2005
Last Updated:	February 4, 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

ClinicalTrials.gov processed this record on September 20, 2017

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