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Completed

NCT Number: NCT01858506

Diabetes Lifestyle Assessment and Educational Tools

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

40 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clalit Health Services, Shomron administration

Hadera, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

I-ACE intervention

Procedure

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

Standard Lifestyle Advice

Procedure

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. Dietary and physical activity behaviours

    Time frame: Baseline and 12 months.

    Dietary and physical activity behaviours, assessed with food frequency and physical activity questionnaires.

  3. 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.

  4. Glycaemic control

    Time frame: Baseline, 3rd,6th, and 12th months.

    Glycaemic control, assessed with HbA1c levels.

  5. Weight and waist circumference

    Time frame: Baseline, 3rd, 6th, and 12th months.

    Change of weight and waist circumference during follow-up.

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Ofra Kalter-Leibovici MD

Other Gov

Collaborators

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

Registry information

Official study title

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

Acronym: I-ACE

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
May 21, 2013
Registry last updated
Apr 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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