Diabetes Lifestyle Assessment and Educational Tools

Study Overview
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Brief Summary
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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
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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.

Official Title
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Development and Evaluation of Lifestyle Assessment and Educational Tools for Diabetic People With Limited Literacy

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Procedure: I-ACE intervention
* Procedure: Standard Lifestyle Advice


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: I-ACE intervention arm<br>lifestyle counselling using the interactive assessment, counselling and education (I-ACE)-based method. | Procedure: I-ACE intervention<br>* lifestyle counselling using the interactive assessment, counselling and education (I-ACE)-based method.<br>|
| Active Comparator: Standard lifestyle advice arm<br>lifestyle counselling using the standard lifestyle advice (SLA) program currently provided to Clalit Health Services patients. | Procedure: Standard Lifestyle Advice<br>* lifestyle counselling using the standard lifestyle advice (SLA) program currently provided to Clalit Health Services patients.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients' lifestyle monitoring | Patient engagement in monitoring diet intake and physical activity, assessed with 3-day dietary and physical activity records. | 1st,2nd,3rd,6th months | 
| Dietary and physical activity behaviours | Dietary and physical activity behaviours, assessed with food frequency and physical activity questionnaires. | Baseline and 12 months. | 
| SBGM practices | Self Blood Glucose Monitoring practices. Information will be downloaded from the blood glucose meters' memory. | 1st, 2nd, 3rd, 6th, 12th months. | 
| Glycaemic control | Glycaemic control, assessed with HbA1c levels. | Baseline, 3rd,6th, and 12th months. | 
| Weight and waist circumference | Change of weight and waist circumference during follow-up. | Baseline, 3rd, 6th, and 12th months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 diabetes mellitus, Lifestyle counselling, Lifestyle assessment, Randomized controlled trial, Diabetes education