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

October 11, 2011 updated by: Oregon Research Institute
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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

227

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Eugene, Oregon, United States, 97403
        • Oregon Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Participants in prior study: Enhancing Support for Women With Type 2 Diabetes, "The Mediterranean Lifestyle Program."

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
1
Treatment condition from first study. This is a follow-up study.
2
Control condition from first study.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oregon Research Institute

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Deborah J. Toobert, Ph.D., Oregon Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2003

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

May 16, 2008

First Submitted That Met QC Criteria

May 16, 2008

First Posted (Estimate)

May 20, 2008

Study Record Updates

Last Update Posted (Estimate)

October 13, 2011

Last Update Submitted That Met QC Criteria

October 11, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HL077120

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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