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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00680849
Recruitment Status : Completed
First Posted : May 20, 2008
Last Update Posted : October 13, 2011
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Type 2 Diabetes Mellitus

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 Design

Study Type : Observational
Actual Enrollment : 227 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Enhancing Support for Women With Type 2 Diabetes: Follow-Up
Study Start Date : December 2003
Primary Completion Date : December 2009
Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Treatment condition from first study. This is a follow-up study.
Control condition from first study.

Outcome Measures

Primary Outcome Measures :
  1. Food Frequency Questionnaire for Fruits, Vegetables and percent calories from fat (FFQ) by Kristal and colleagues [ Time Frame: annually, 36 months - 84 months ]

Secondary Outcome Measures :
  1. Lipids, weight loss [ Time Frame: annually, 36 months - 84 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Participants in prior study: Enhancing Support for Women With Type 2 Diabetes, "The Mediterranean Lifestyle Program."

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00680849

United States, Oregon
Oregon Research Institute
Eugene, Oregon, United States, 97403
Sponsors and Collaborators
Oregon Research Institute
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Deborah J. Toobert, Ph.D. Oregon Research Institute
More Information


Responsible Party: Oregon Research Institute
ClinicalTrials.gov Identifier: NCT00680849     History of Changes
Other Study ID Numbers: HL077120
First Posted: May 20, 2008    Key Record Dates
Last Update Posted: October 13, 2011
Last Verified: October 2011

Keywords provided by Oregon Research Institute:
Type 2 Diabetes Mellitus
Coronary Disease

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases