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

This study has been completed.

Sponsor:

Collaborator:

National Heart, Lung, and Blood Institute (NHLBI)

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

History of Changes

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:

MedlinePlus related topics: Diabetes Diabetes Type 2

U.S. FDA Resources

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

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

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Principal Investigator:

Deborah J. Toobert, Ph.D.

Oregon Research Institute

More Information

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.

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(2 Suppl):S118-25.

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.

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.

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.

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.

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
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on June 17, 2013

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