Ignite Creation Date:
2024-05-05 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00142701
Status:
COMPLETED
Last Update Posted:
2016-02-08
First Post:
2005-09-01
Brief Title:
Enhancing Support for Women at Risk for Heart Disease
Sponsor:
Oregon Research Institute
Organization:
Oregon Research Institute
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2016-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 eg dietary intake exercise levels stress management smoking cessation physiological risk factors associated with CHD eg serum lipids hypertension weight vascular reactivity HbA1c glycated hemoglobin a measure of diabetes and quality of life eg depression functioning
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 eg dietary intake exercise levels stress management smoking cessation physiological risk factors associated with CHD eg serum lipids hypertension weight vascular reactivity HbA1c glycated hemoglobin a measure of diabetes and quality of life eg depression functioning
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL062156 | NIH | None | httpsreporternihgovquickSearchR01HL062156 |