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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Oregon Research Institute
ClinicalTrials.gov Identifier:
NCT00680849
First received: May 16, 2008
Last updated: October 11, 2011
Last verified: October 2011
  Purpose

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
Type 2 Diabetes Mellitus

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Enhancing Support for Women With Type 2 Diabetes: Follow-Up

Resource links provided by NLM:


Further study details as provided by Oregon Research Institute:

Primary Outcome Measures:
  • Food Frequency Questionnaire for Fruits, Vegetables and percent calories from fat (FFQ) by Kristal and colleagues [ Time Frame: annually, 36 months - 84 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Lipids, weight loss [ Time Frame: annually, 36 months - 84 months ] [ Designated as safety issue: No ]

Enrollment: 227
Study Start Date: December 2003
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Treatment condition from first study. This is a follow-up study.
2
Control condition from first study.

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.

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders 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."

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00680849

Locations
United States, Oregon
Oregon Research Institute
Eugene, Oregon, United States, 97403
Sponsors and Collaborators
Oregon Research Institute
Investigators
Principal Investigator: Deborah J. Toobert, Ph.D. Oregon Research Institute
  More Information

Publications:
Responsible Party: Oregon Research Institute
ClinicalTrials.gov Identifier: NCT00680849     History of Changes
Other Study ID Numbers: HL077120
Study First Received: May 16, 2008
Last Updated: October 11, 2011
Health Authority: United States: Institutional Review Board
United States: Federal Government

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

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

ClinicalTrials.gov processed this record on November 27, 2014