Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005441
Status:
COMPLETED
Last Update Posted:
2016-02-08
First Post:
2000-05-25
Brief Title:
Lifestyle Management for Women With CHD and NIDDM
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 develop and evaluate a comprehensive lifestyle self-management CLSM program low-fat vegetarian diet smoking cessation and stress management training for postmenopausal women with coronary heart disease and Type II non-insulin dependent diabetes
Detailed Description:
BACKGROUND
Coronary heart disease is the leading cause of death among postmenopausal women Yet few studies have examined the potential for altering risk factors for coronary heart diseases among postmenopausal women especially as a result of comprehensive lifestyle changes A pressing need existed for controlled studies to evaluate the effects of comprehensive lifestyle changes on risks for coronary heart disease among postmenopausal women
DESIGN NARRATIVE
The comprehensive lifestyle management program appeared to produce substantial cardiovascular benefits among men but little was known about the behavioral processes through which change occurred Its generalizability and applicability -- especially for high-risk women --was uncertain The program was compared to a usual care condition in an initial randomized trial Outcome measures included patient self-care behaviors and health outcomes serum lipid profiles blood pressure relative weight and glycemic control Process measures included self-efficacy personal health models perceived stress social support and problem-solving skills Subjects participated in the intervention for three years with gradual fading of the program in the third year to evaluate the long-term effects of the program Analyses included assessments of between groups differences on physiological risk factors behavioral lifestyle measures and process measures as well as maintenance over time Based upon the results of this study the long-term goal was to design a second outcome study in which the revised intervention would be evaluated with a larger sample to determine the relative contribution of adding moderate exercise and the effects on reversal of coronary heart disease
Coronary heart disease is the leading cause of death among postmenopausal women Yet few studies have examined the potential for altering risk factors for coronary heart diseases among postmenopausal women especially as a result of comprehensive lifestyle changes A pressing need existed for controlled studies to evaluate the effects of comprehensive lifestyle changes on risks for coronary heart disease among postmenopausal women
DESIGN NARRATIVE
The comprehensive lifestyle management program appeared to produce substantial cardiovascular benefits among men but little was known about the behavioral processes through which change occurred Its generalizability and applicability -- especially for high-risk women --was uncertain The program was compared to a usual care condition in an initial randomized trial Outcome measures included patient self-care behaviors and health outcomes serum lipid profiles blood pressure relative weight and glycemic control Process measures included self-efficacy personal health models perceived stress social support and problem-solving skills Subjects participated in the intervention for three years with gradual fading of the program in the third year to evaluate the long-term effects of the program Analyses included assessments of between groups differences on physiological risk factors behavioral lifestyle measures and process measures as well as maintenance over time Based upon the results of this study the long-term goal was to design a second outcome study in which the revised intervention would be evaluated with a larger sample to determine the relative contribution of adding moderate exercise and the effects on reversal of coronary heart disease
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 |
|---|---|---|---|
| R29HL050181 | NIH | None | httpsreporternihgovquickSearchR29HL050181 |