Clinical trial NCT01858506: Diabetes Lifestyle Assessment and Educational Tools
Official title: Development and Evaluation of Lifestyle Assessment and Educational Tools for Diabetic People With Limited Literacy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 diabetes mellitus
Lifestyle counselling
Lifestyle assessment
Randomized controlled trial
Diabetes education
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: The Gertner Institute
name: Clalit Health Services
name: European Foundation for the Study of Diabetes
First posted: 2013-05-21
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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 will evaluate the effectiveness of this method for: a) increasing patients' knowledge and understanding of the role of lifestyle (diet and physical activity) in diabetes management; b) improving patients' engagement in monitoring dietary intake and physical activity; c) improving dietary and physical activity behaviors and self-blood glucose monitoring (SBGM) practices; d) improving glycaemic control; and, e) improving the efficiency of lifestyle assessment, education and counseling while increasing patients' engagement in the process.

Eligibility criteria: Inclusion Criteria:

* 40-64 years old
* BMI 27-45 kg/m2
* Diagnosis of type 2 diabetes mellitus in medical record
* HbA1c 8.0%-11.5%

Exclusion Criteria:

* 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).

Primary outcomes:
measure: Change in lifestyle knowledge
timeFrame: Baseline, 3rd,6th,12th months
Secondary outcomes:
measure: Patients' lifestyle monitoring
timeFrame: 1st,2nd,3rd,6th months
measure: Dietary and physical activity behaviours
timeFrame: Baseline and 12 months.
measure: SBGM practices
timeFrame: 1st, 2nd, 3rd, 6th, 12th months.
measure: Glycaemic control
timeFrame: Baseline, 3rd,6th, and 12th months.
measure: Weight and waist circumference
timeFrame: Baseline, 3rd, 6th, and 12th months.
Other outcomes:
measure: Medical regimen for diabetes management
timeFrame: Baseline, 1st, 2nd, 3rd, 6th, and 12th month.
Locations:
city: Hadera
country: Israel
facility: Clalit Health Services, Shomron administration
Study officials:
affiliation: Sheba Medical Center, the Gertner Institute for Epidemiology & Health Policy Research
name: Ofra Kalter-Leibovici, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Gertner Institute for Epidemiology & Health Policy Research
name: Kathleen Abu-Saad, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.