Enhancing Support for Women With Type 2 Diabetes: Follow-Up

Study Overview
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Brief Summary
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This study is a 5-year continuation of The Mediterranean Lifestyle Program. The purpose of this follow-up study is to determine the long-term effects from prior participation in an intervention promoting healthful eating, exercise, quitting smoking, stress management, and social support. Participants are post-menopausal women with type 2 diabetes.

Detailed Description
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Coronary heart disease (CHD) is the leading cause of death and functional limitations among women in the U.S. Postmenopausal women with diabetes are at especially high risk of CHD, but CHD research with this population is very limited. This project addresses the poorly understood natural history of long-term maintenance of change in multiple behaviors (i.e., dietary, physical activity, social support, smoking cessation, and stress management) related to CHD risk, as well as the effects of theoretically important mediating variables on relapse and maintenance. The study is a continuation of a research project that has already demonstrated significant and consistent positive effects of a lifestyle change intervention on reduction of behavioral CHD risk factors. This research relies on a framework that synthesizes social-cognitive, social-ecologic, and goal-systems theories.

Official Title
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Enhancing Support for Women With Type 2 Diabetes: Follow-Up

Conditions
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Type 2 Diabetes Mellitus

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All participants in the original study are eligible. The inclusion criteria for the original study were: diagnosis of type 2 diabetes for at least 6 months being post-menopausal living independently (e.g., not in an institution or nursing home) having a telephone ability to read English not being developmentally disabled, and living within 30 miles of the Eugene-Springfield metropolitan area. Exclusion Criteria: Exclusion criteria for the original study included: being older than 75 years of age having life-threatening illnesses, or planning to move from the local area within the time span of the study.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Treatment condition from first study. This is a follow-up study. | |
| 2<br>Control condition from first study. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Food Frequency Questionnaire for Fruits, Vegetables and percent calories from fat (FFQ) by Kristal and colleagues |  | annually, 36 months - 84 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lipids, weight loss |  | annually, 36 months - 84 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 Diabetes Mellitus, Coronary Disease