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

NCT ID: NCT00680849

Last Updated: 2011-10-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

227 participants

Study Classification

OBSERVATIONAL

Study Start Date

2003-12-31

Study Completion Date

2009-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Type 2 Diabetes Mellitus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

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

No interventions assigned to this group

2

Control condition from first study.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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

* 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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

Oregon Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Deborah J. Toobert, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Oregon Research Institute

Locations

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Oregon Research Institute

Eugene, Oregon, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 16774900 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18377153 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17522413 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18248105 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16977910 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16971709 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17306031 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17229325 (View on PubMed)

Other Identifiers

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HL077120

Identifier Type: -

Identifier Source: org_study_id