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CompletedNCT00680849Updated Oct 13, 2011

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

An observational study in Type 2 Diabetes Mellitus, sponsored by Oregon Research Institute. Completed at 1 site in United States. Open to female participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2011-10-13.

Sponsored by Oregon Research Institute · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
227
Ages
40 Years to 75 Years
Sex
Female
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Study 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.

Read the 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.

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Conditions studied

  • Type 2 Diabetes Mellitus

Keywords

  • Type 2 Diabetes Mellitus
  • Coronary Disease
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In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 227 is close to the median of 233 across 2,220 observational studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Oregon Research Institute is the lead sponsor of 70 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
40 Years to 75 Years
Sexes eligible
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."

Eligibility 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.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
227 participants (actual)

Groups and cohorts

  • 1

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

  • 2

    Control condition from first study.

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What researchers measure

Primary outcomes

  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 outcomes

  1. Lipids, weight loss

    Time frame: annually, 36 months - 84 months

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Study locations

1 site
  • Oregon Research Institute
    Eugene, Oregon 97403, United States
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References and documents

Publications

  • Barrera M Jr, Toobert DJ, Angell KL, Glasgow RE, Mackinnon DP. Social support and social-ecological resources as mediators of lifestyle intervention effects for type 2 diabetes. J Health Psychol. 2006 May;11(3):483-95. doi: 10.1177/1359105306063321. PubMed 16774900 ↗
  • Barrera M, Strycker LA, Mackinnon DP, Toobert DJ. Social-ecological resources as mediators of two-year diet and physical activity outcomes in type 2 diabetes patients. Health Psychol. 2008 Mar;27(2S):S118-25. doi: 10.1037/0278-6133.27.2(Suppl.).S118. PubMed 18377153 ↗
  • Greene GW, Nebeling LC, Greaney ML, Lindsay AC, Hardwick CK, Toobert DJ, Resnicow K, Williams GC, Elliot DL, Goldman Sher T, McGregor HA, Domas A, DeFrancesco CA, Peterson KE. A qualitative study of a nutrition working group. Health Promot Pract. 2007 Jul;8(3):299-306. doi: 10.1177/1524839906292587. Epub 2007 May 23. PubMed 17522413 ↗
  • Hellsten LA, Nigg C, Norman G, Burbank P, Braun L, Breger R, Coday M, Elliot D, Garber C, Greaney M, Lees F, Matthews C, Moe E, Resnick B, Riebe D, Rossi J, Toobert D, Wang T. Accumulation of behavioral validation evidence for physical activity stage of change. Health Psychol. 2008 Jan;27(1S):S43-53. doi: 10.1037/0278-6133.27.1(Suppl.).S43. PubMed 18248105 ↗
  • King AC, Toobert D, Ahn D, Resnicow K, Coday M, Riebe D, Garber CE, Hurtz S, Morton J, Sallis JF. Perceived environments as physical activity correlates and moderators of intervention in five studies. Am J Health Promot. 2006 Sep-Oct;21(1):24-35. doi: 10.1177/089011710602100106. PubMed 16977910 ↗
  • Ritzwoller DP, Toobert D, Sukhanova A, Glasgow RE. Economic analysis of the Mediterranean Lifestyle Program for postmenopausal women with diabetes. Diabetes Educ. 2006 Sep-Oct;32(5):761-9. doi: 10.1177/0145721706291757. PubMed 16971709 ↗
  • Strycker LA, Duncan SC, Chaumeton NR, Duncan TE, Toobert DJ. Reliability of pedometer data in samples of youth and older women. Int J Behav Nutr Phys Act. 2007 Feb 17;4:4. doi: 10.1186/1479-5868-4-4. PubMed 17306031 ↗
  • Toobert DJ, Glasgow RE, Strycker LA, Barrera M Jr, Ritzwoller DP, Weidner G. Long-term effects of the Mediterranean lifestyle program: a randomized clinical trial for postmenopausal women with type 2 diabetes. Int J Behav Nutr Phys Act. 2007 Jan 17;4:1. doi: 10.1186/1479-5868-4-1. PubMed 17229325 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 13, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00680849
Lead sponsor
Oregon Research Institute
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Responsible party
Sponsor
First posted
May 20, 2008
Start date
Dec 2003
Primary completion
Dec 2009
Completion
Dec 2009
Last update
Oct 13, 2011

Study contacts

Deborah J. Toobert, Ph.D.
principal investigator · Oregon Research Institute

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2011. You cannot join it, but the record below documents what was studied.

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