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Enhancing Support for Women at Risk for Heart Disease

Primary Purpose

Cardiovascular Diseases, Heart Diseases, Coronary Disease

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
diet
physical activity
stress management
smoking cessation
Sponsored by
Oregon Research Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cardiovascular Diseases

Eligibility Criteria

undefined - 100 Years (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

No eligibility criteria

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    September 1, 2005
    Last Updated
    February 4, 2016
    Sponsor
    Oregon Research Institute
    Collaborators
    National Heart, Lung, and Blood Institute (NHLBI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00142701
    Brief Title
    Enhancing Support for Women at Risk for Heart Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    April 1999 (undefined)
    Primary Completion Date
    September 2004 (Actual)
    Study Completion Date
    March 2005 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Oregon Research Institute
    Collaborators
    National Heart, Lung, and Blood Institute (NHLBI)

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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).
    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cardiovascular Diseases, Heart Diseases, Coronary Disease, Coronary Heart Disease Risk Reduction, Diabetes Mellitus, Non-insulin Dependent

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Allocation
    Randomized

    8. Arms, Groups, and Interventions

    Intervention Type
    Behavioral
    Intervention Name(s)
    diet
    Intervention Type
    Behavioral
    Intervention Name(s)
    physical activity
    Intervention Type
    Behavioral
    Intervention Name(s)
    stress management
    Intervention Type
    Behavioral
    Intervention Name(s)
    smoking cessation

    10. Eligibility

    Sex
    Female
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    No eligibility criteria
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Deborah Toobert
    Organizational Affiliation
    Oregon Research Institute

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    15823786
    Citation
    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. doi: 10.1207/s15324796abm2902_7.
    Results Reference
    background
    PubMed Identifier
    15572438
    Citation
    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. doi: 10.1093/her/cyg140. Epub 2004 Nov 30.
    Results Reference
    background
    PubMed Identifier
    12882850
    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. doi: 10.2337/diacare.26.8.2288.
    Results Reference
    background
    PubMed Identifier
    12408202
    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. doi: 10.1093/her/17.5.574.
    Results Reference
    background
    PubMed Identifier
    12401412
    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. doi: 10.1016/s0738-3991(02)00120-9.
    Results Reference
    background

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    Enhancing Support for Women at Risk for Heart Disease

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