Diabetes Lifestyle Assessment and Educational Tools

Type 2 Diabetes Mellitus Clinical Trial

— I-ACE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01858506
• Other study ID #: EFSD_I-ACE
• Secondary ID: 8677-11-SMC
• Status: Completed
• Phase: N/A
• First received: May 12, 2013
• Last updated: April 14, 2016
• Start date: August 2014
• Est. completion date: March 2016

Study information

• Verified date: April 2016
• Source: Sheba Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 64 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

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

Locations

Country	Name	City	State
Israel	Clalit Health Services, Shomron administration	Hadera

Sponsors (4)

Lead Sponsor	Collaborator
Ofra Kalter-Leibovici MD	Clalit Health Services, European Foundation for the Study of Diabetes, The Gertner Institute for Epidemiology & Health Policy Research

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Medical regimen for diabetes management	Medical regimen for diabetes management, i.e. self-reported medical treatment for diabetes.	Baseline, 1st, 2nd, 3rd, 6th, and 12th month.	No
Primary	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	No
Secondary	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	No
Secondary	Dietary and physical activity behaviours	Dietary and physical activity behaviours, assessed with food frequency and physical activity questionnaires.	Baseline and 12 months.	No
Secondary	SBGM practices	Self Blood Glucose Monitoring practices. Information will be downloaded from the blood glucose meters' memory.	1st, 2nd, 3rd, 6th, 12th months.	No
Secondary	Glycaemic control	Glycaemic control, assessed with HbA1c levels.	Baseline, 3rd,6th, and 12th months.	No
Secondary	Weight and waist circumference	Change of weight and waist circumference during follow-up.	Baseline, 3rd, 6th, and 12th months.	No