Diabetes Lifestyle Assessment and Educational Tools (I-ACE)

Ofra Kalter-Leibovici MD

Status: Completed

Conditions: Type 2 Diabetes Mellitus

Treatments: Procedure: Standard Lifestyle Advice; Procedure: I-ACE intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT01858506

EFSD_I-ACE

8677-11-SMC (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 40 to 64 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

I-ACE intervention arm

Experimental group

Description:

lifestyle counselling using the interactive assessment, counselling and education (I-ACE)-based method.

Treatment:

Procedure: I-ACE intervention

Standard lifestyle advice arm

Active Comparator group

Description:

lifestyle counselling using the standard lifestyle advice (SLA) program currently provided to Clalit Health Services patients.

Treatment:

Procedure: Standard Lifestyle Advice