Diabetes Lifestyle Assessment and Educational Tools

Not Applicable

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Procedure: I-ACE intervention; Procedure: Standard Lifestyle Advice

• Registration Number: NCT01858506
• Lead Sponsor: Ofra Kalter-Leibovici MD

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.

Study Timeline

• Study First Submitted: 2013-05-12
• Study First Submitted QC: 2013-05-20
• Study First Posted: 2013-05-21
• Study Start: 2014-08
• Primary Completion: 2016-02
• Study Completion: 2016-03
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-14
• Last Update Posted: 2016-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
I-ACE intervention arm	I-ACE intervention	lifestyle counselling using the interactive assessment, counselling and education (I-ACE)-based method.
Standard lifestyle advice arm	Standard Lifestyle Advice	lifestyle counselling using the standard lifestyle advice (SLA) program currently provided to Clalit Health Services patients.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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.

Trial Locations

Locations (1)

Clalit Health Services, Shomron administration; 🇮🇱 Hadera, Israel