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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

May 16, 2008
October 11, 2011
December 2003
December 2009   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00680849 on ClinicalTrials.gov Archive Site
Lipids, weight loss [ Time Frame: annually, 36 months - 84 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Enhancing Support for Women With Type 2 Diabetes: Follow-Up
Enhancing Support for Women With Type 2 Diabetes: Follow-Up

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

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

Type 2 Diabetes Mellitus
Not Provided
  • 1
    Treatment condition from first study. This is a follow-up study.
  • 2
    Control condition from first study.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
227
December 2009
December 2009   (final data collection date for primary outcome measure)

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.
Female
40 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00680849
HL077120
Yes
Oregon Research Institute
Oregon Research Institute
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Deborah J. Toobert, Ph.D. Oregon Research Institute
Oregon Research Institute
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP