Diabetes Lifestyle Assessment and Educational Tools (I-ACE)

April 14, 2016 updated by: Ofra Kalter-Leibovici MD

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Hadera, Israel
        • Clalit Health Services, Shomron administration

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in lifestyle knowledge
Time Frame: 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.
Baseline, 3rd,6th,12th months

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Medical regimen for diabetes management
Time Frame: Baseline, 1st, 2nd, 3rd, 6th, and 12th month.
Medical regimen for diabetes management, i.e. self-reported medical treatment for diabetes.
Baseline, 1st, 2nd, 3rd, 6th, and 12th month.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ofra Kalter-Leibovici MD

Collaborators

Clalit Health Services
The Gertner Institute
European Foundation for the Study of Diabetes

Investigators

  • Principal Investigator: Ofra Kalter-Leibovici, M.D., Sheba Medical Center, the Gertner Institute for Epidemiology & Health Policy Research
  • Principal Investigator: Kathleen Abu-Saad, Ph.D., Gertner Institute for Epidemiology & Health Policy Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

May 12, 2013

First Submitted That Met QC Criteria

May 20, 2013

First Posted (Estimate)

May 21, 2013

Study Record Updates

Last Update Posted (Estimate)

April 15, 2016

Last Update Submitted That Met QC Criteria

April 14, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EFSD_I-ACE
  • 8677-11-SMC (Other Identifier: Sheba Medical Center Helsinki Committee)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Type 2 Diabetes Mellitus

Clinical Trials on I-ACE intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Congo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe