Clinical trial NCT00680849: Enhancing Support for Women With Type 2 Diabetes: Follow-Up
Official title: Enhancing Support for Women With Type 2 Diabetes: Follow-Up
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 Diabetes Mellitus
Coronary Disease
Lead sponsor: Oregon Research Institute
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2008-05-20
Enrollment: 227
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants in prior study: Enhancing Support for Women With Type 2 Diabetes, "The Mediterranean Lifestyle Program."

Brief 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.

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 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.

Primary outcomes:
measure: Food Frequency Questionnaire for Fruits, Vegetables and percent calories from fat (FFQ) by Kristal and colleagues
timeFrame: annually, 36 months - 84 months
Secondary outcomes:
measure: Lipids, weight loss
timeFrame: annually, 36 months - 84 months
Other outcomes:
Locations:
city: Eugene
country: United States
facility: Oregon Research Institute
state: Oregon
Study officials:
affiliation: Oregon Research Institute
name: Deborah J. Toobert, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.