Study Results
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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COMPLETED
NA
50 participants
INTERVENTIONAL
2014-08-31
2016-03-31
Brief Summary
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The investigators hypothesize that this tool will: a) increase patients' knowledge and understanding of the role of lifestyle (diet and physical activity) in diabetes management; b) improve patients' engagement in monitoring dietary intake and physical activity; c) improve dietary and physical activity behaviors and self-blood glucose monitoring (SBGM) practices; d) improve glycemic control; and, e) improve the efficiency of lifestyle assessment, education and counseling while increasing patients' engagement in the process.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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I-ACE intervention arm
lifestyle counselling using the interactive assessment, counselling and education (I-ACE)-based method.
I-ACE intervention
lifestyle counselling using the interactive assessment, counselling and education (I-ACE)-based method.
Standard lifestyle advice arm
lifestyle counselling using the standard lifestyle advice (SLA) program currently provided to Clalit Health Services patients.
Standard Lifestyle Advice
lifestyle counselling using the standard lifestyle advice (SLA) program currently provided to Clalit Health Services patients.
Interventions
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I-ACE intervention
lifestyle counselling using the interactive assessment, counselling and education (I-ACE)-based method.
Standard Lifestyle Advice
lifestyle counselling using the standard lifestyle advice (SLA) program currently provided to Clalit Health Services patients.
Eligibility Criteria
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Inclusion Criteria
* BMI 27-45 kg/m2
* Diagnosis of type 2 diabetes mellitus in medical record
* HbA1c 8.0%-11.5%
Exclusion Criteria
* Inadequate control of co-morbid conditions
* Factors that may limit adherence to interventions (e.g., any medical or physical condition that limits the ability to participate in physical activity or standard diets recommended for people with diabetes, pregnancy, uncontrolled psychiatric condition, significant cognitive impairment, blindness).
40 Years
64 Years
ALL
No
Sponsors
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The Gertner Institute
OTHER
Clalit Health Services
OTHER
European Foundation for the Study of Diabetes
OTHER
Ofra Kalter-Leibovici MD
OTHER_GOV
Responsible Party
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Ofra Kalter-Leibovici MD
Director of the Unit of Cardiovascular Epidemiology, The Gertner Institute for Epidemiology & Health Policy Research.
Principal Investigators
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Ofra Kalter-Leibovici, M.D.
Role: PRINCIPAL_INVESTIGATOR
Sheba Medical Center, the Gertner Institute for Epidemiology & Health Policy Research
Kathleen Abu-Saad, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Gertner Institute for Epidemiology & Health Policy Research
Locations
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Clalit Health Services, Shomron administration
Hadera, , Israel
Countries
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References
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Abu-Saad K, Murad H, Barid R, Olmer L, Ziv A, Younis-Zeidan N, Kaufman-Shriqui V, Gillon-Keren M, Rigler S, Berchenko Y, Kalter-Leibovici O. Development and Efficacy of an Electronic, Culturally Adapted Lifestyle Counseling Tool for Improving Diabetes-Related Dietary Knowledge: Randomized Controlled Trial Among Ethnic Minority Adults With Type 2 Diabetes Mellitus. J Med Internet Res. 2019 Oct 16;21(10):e13674. doi: 10.2196/13674.
Other Identifiers
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8677-11-SMC
Identifier Type: OTHER
Identifier Source: secondary_id
EFSD_I-ACE
Identifier Type: -
Identifier Source: org_study_id
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