Type 2 Diabetes Mellitus
Conditions
Keywords
Type 2 diabetes mellitus, Lifestyle counselling, Lifestyle assessment, Randomized controlled trial, Diabetes education
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.
Interventions
PROCEDUREI-ACE intervention
lifestyle counselling using the interactive assessment, counselling and education (I-ACE)-based method.
PROCEDUREStandard Lifestyle Advice
lifestyle counselling using the standard lifestyle advice (SLA) program currently provided to Clalit Health Services patients.
Sponsors
The Gertner Institute
Clalit Health Services
European Foundation for the Study of Diabetes
Ofra Kalter-Leibovici MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 64 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in lifestyle knowledge | Baseline, 3rd,6th,12th months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patients' lifestyle monitoring | 1st,2nd,3rd,6th months | Patient engagement in monitoring diet intake and physical activity, assessed with 3-day dietary and physical activity records. |
| Dietary and physical activity behaviours | Baseline and 12 months. | Dietary and physical activity behaviours, assessed with food frequency and physical activity questionnaires. |
| Glycaemic control | Baseline, 3rd,6th, and 12th months. | Glycaemic control, assessed with HbA1c levels. |
| Weight and waist circumference | Baseline, 3rd, 6th, and 12th months. | Change of weight and waist circumference during follow-up. |
| SBGM practices | 1st, 2nd, 3rd, 6th, 12th months. | Self Blood Glucose Monitoring practices. Information will be downloaded from the blood glucose meters' memory. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Medical regimen for diabetes management | Baseline, 1st, 2nd, 3rd, 6th, and 12th month. | Medical regimen for diabetes management, i.e. self-reported medical treatment for diabetes. |
Countries
Israel
Outcome results
None listed