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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00680849

Enrollment

227

Registered

2008-05-20

Start date

2003-12-31

Completion date

2009-12-31

Last updated

2011-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

Keywords

Type 2 Diabetes Mellitus, Coronary Disease

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

40 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
Lipids, weight loss	annually, 36 months - 84 months

Countries

United States

Outcome results