Diabetes Lifestyle Assessment and Educational Tools
I-ACE
Development and Evaluation of Lifestyle Assessment and Educational Tools for Diabetic People With Limited Literacy
2 other identifiers
interventional
50
1 country
1
Brief Summary
Aim: To evaluate a culturally-adapted method of lifestyle assessment, counseling, and education among Arab people with diabetes who have varying literacy skills using an interactive computerized tool and graphically-enhanced patient logs for dietary and physical activity. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable type-2-diabetes-mellitus
Started Aug 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 12, 2013
CompletedFirst Posted
Study publicly available on registry
May 21, 2013
CompletedStudy Start
First participant enrolled
August 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedApril 15, 2016
April 1, 2016
1.5 years
May 12, 2013
April 14, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in lifestyle knowledge
Change in diabetes-related lifestyle (diet and physical activity) knowledge, will be assessed with a diet knowledge questionnaire specially adapted for this population. Change in physical activity knowledge will be measured with the SKILLD diabetes knowledge questionnaire.
Baseline, 3rd,6th,12th months
Secondary Outcomes (5)
Patients' lifestyle monitoring
1st,2nd,3rd,6th months
Dietary and physical activity behaviours
Baseline and 12 months.
SBGM practices
1st, 2nd, 3rd, 6th, 12th months.
Glycaemic control
Baseline, 3rd,6th, and 12th months.
Weight and waist circumference
Baseline, 3rd, 6th, and 12th months.
Other Outcomes (1)
Medical regimen for diabetes management
Baseline, 1st, 2nd, 3rd, 6th, and 12th month.
Study Arms (2)
I-ACE intervention arm
EXPERIMENTALlifestyle counselling using the interactive assessment, counselling and education (I-ACE)-based method.
Standard lifestyle advice arm
ACTIVE COMPARATORlifestyle counselling using the standard lifestyle advice (SLA) program currently provided to Clalit Health Services patients.
Interventions
lifestyle counselling using the interactive assessment, counselling and education (I-ACE)-based method.
lifestyle counselling using the standard lifestyle advice (SLA) program currently provided to Clalit Health Services patients.
Eligibility Criteria
You may qualify if:
- years old
- BMI 27-45 kg/m2
- Diagnosis of type 2 diabetes mellitus in medical record
- HbA1c 8.0%-11.5%
You may not qualify if:
- Short-acting insulin treatment
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ofra Kalter-Leibovici MDlead
- The Gertner Institutecollaborator
- Clalit Health Servicescollaborator
- European Foundation for the Study of Diabetescollaborator
Study Sites (1)
Clalit Health Services, Shomron administration
Hadera, Israel
Related Publications (1)
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.
PMID: 31621640DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ofra Kalter-Leibovici, M.D.
Sheba Medical Center, the Gertner Institute for Epidemiology & Health Policy Research
- PRINCIPAL INVESTIGATOR
Kathleen Abu-Saad, Ph.D.
Gertner Institute for Epidemiology & Health Policy Research
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Director of the Unit of Cardiovascular Epidemiology, The Gertner Institute for Epidemiology & Health Policy Research.
Study Record Dates
First Submitted
May 12, 2013
First Posted
May 21, 2013
Study Start
August 1, 2014
Primary Completion
February 1, 2016
Study Completion
March 1, 2016
Last Updated
April 15, 2016
Record last verified: 2016-04