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

Completed

• Conditions: Type 2 Diabetes Mellitus

• Registration Number: NCT00680849
• Lead Sponsor: Oregon Research Institute

Brief Summary

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

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.

Study Timeline

• Study Start: 2003-12
• Study First Submitted: 2008-05-16
• Study First Submitted QC: 2008-05-16
• Study First Posted: 2008-05-20
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2011-10
• Last Update Submitted: 2011-10-11
• Last Update Posted: 2011-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 227

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Food Frequency Questionnaire for Fruits, Vegetables and percent calories from fat (FFQ) by Kristal and colleagues	annually, 36 months - 84 months

Secondary Outcome Measures

Name	Time	Method
Lipids, weight loss	annually, 36 months - 84 months

Trial Locations

Locations (1)

Oregon Research Institute; 🇺🇸 Eugene, Oregon, United States