Type 2 Diabetes MellitusI-ACENCT01858506
Diabetes Lifestyle Assessment and Educational Tools
A study testing I-ACE intervention and Standard Lifestyle Advice in people with Type 2 Diabetes Mellitus, run by Ofra Kalter-Leibovici MD at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 40 to 64 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- I-ACE intervention and Standard Lifestyle Advice
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2014to Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 40-64 years old
- BMI 27-45 kg/m2
- Diagnosis of type 2 diabetes mellitus in medical record
- HbA1c 8.0%-11.5%
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- I-ACE intervention, Standard Lifestyle Advice
- Keywords
- Type 2 diabetes mellitus, Lifestyle counselling, Lifestyle assessment, Randomized controlled trial, Diabetes education
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
I-ACE interventionProcedure or surgery
lifestyle counselling using the interactive assessment, counselling and education (I-ACE)-based method.
Standard Lifestyle AdviceProcedure or surgery
lifestyle counselling using the standard lifestyle advice (SLA) program currently provided to Clalit Health Services patients.
| Study group | Role | What they receive |
|---|---|---|
| I-ACE intervention arm | Experimental | lifestyle counselling using the interactive assessment, counselling and education (I-ACE)-based method. Receives: Procedure: I-ACE intervention |
| Standard lifestyle advice arm | Active comparator | lifestyle counselling using the standard lifestyle advice (SLA) program currently provided to Clalit Health Services patients. Receives: Procedure: Standard Lifestyle Advice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 3rd,6th,12th months
Secondary outcomes (5)
Patients' lifestyle monitoring
Patient engagement in monitoring diet intake and physical activity, assessed with 3-day dietary and physical activity records.
Measured: 1st,2nd,3rd,6th months
Dietary and physical activity behaviours
Dietary and physical activity behaviours, assessed with food frequency and physical activity questionnaires.
Measured: Baseline and 12 months.
SBGM practices
Self Blood Glucose Monitoring practices. Information will be downloaded from the blood glucose meters' memory.
Measured: 1st, 2nd, 3rd, 6th, 12th months.
Glycaemic control
Glycaemic control, assessed with HbA1c levels.
Measured: Baseline, 3rd,6th, and 12th months.
Weight and waist circumference
Change of weight and waist circumference during follow-up.
Measured: Baseline, 3rd, 6th, and 12th months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2013 (estimated)
- Study startAug 2014
- Primary completionFeb 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ofra Kalter-Leibovici MD
- Sponsor type
- Other government
- Collaborators
- The Gertner Institute, Clalit Health Services, European Foundation for the Study of Diabetes
- Responsible party
- Sponsor-investigator, Ofra Kalter-Leibovici MD, Sheba Medical Center
- Investigators
- Ofra Kalter-Leibovici, M.D., Principal investigator, Sheba Medical Center, the Gertner Institute for Epidemiology & Health Policy ResearchKathleen Abu-Saad, Ph.D., Principal investigator, Gertner Institute for Epidemiology & Health Policy Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01858506
- Sponsor's protocol ID
- EFSD_I-ACE
- Other IDs
- 8677-11-SMC
- Acronym
- I-ACE
- Status last verified
- Apr 2016
- First submitted
- 12 May 2013
- Last updated
- 15 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Abu-Saad K, Murad H, Barid R, Olmer L, Ziv A, Younis-Zeidan N, Kaufman-Shriqui V, Gillon-Keren M, Rigler S, Berchenko Y, Kalter-Leibovici O. Development and Efficacy of an Electronic, Culturally Adapted Lifestyle Counseling Tool for Improving Diabetes-Related Dietary Knowledge: Randomized Controlled Trial Among Ethnic Minority Adults With Type 2 Diabetes Mellitus. J Med Internet Res. 2019 Oct 16;21(10):e13674. doi: 10.2196/13674.
PubMed 31621640
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of Lifestyle Assessment and Educational Tools for Diabetic People With Limited Literacy
- ClinicalTrials.gov ID
- NCT01858506
- Acronym / sponsor ID
- I-ACE / EFSD_I-ACE
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Type 2 diabetes mellitus, Lifestyle counselling, Lifestyle assessment, Randomized controlled trial, Diabetes education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ofra Kalter-Leibovici MDOther government
- Collaborators
- The Gertner Institute, Clalit Health Services, European Foundation for the Study of Diabetes
- Study start
- Aug 2014
- Primary completion
- Feb 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 21 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| I-ACE intervention arm | Experimental | Procedure: I-ACE interventionlifestyle counselling using the interactive assessment, counselling and education (I-ACE)-based method. |
| Standard lifestyle advice arm | Active comparator | Procedure: Standard Lifestyle Advicelifestyle counselling using the standard lifestyle advice (SLA) program currently provided to Clalit Health Services patients. |
Who may qualify
- Ages
- 40 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 40-64 years old
- BMI 27-45 kg/m2
- Diagnosis of type 2 diabetes mellitus in medical record
- HbA1c 8.0%-11.5%
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| I-ACE interventionlifestyle counselling using the interactive assessment, counselling and education (I-ACE)-based method. | Procedure or surgery | I-ACE intervention arm |
| Standard Lifestyle Advicelifestyle counselling using the standard lifestyle advice (SLA) program currently provided to Clalit Health Services patients. | Procedure or surgery | Standard lifestyle advice arm |
Primary outcome
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.
5 secondary outcomes
Patients' lifestyle monitoring
Time frame: 1st,2nd,3rd,6th months
Dietary and physical activity behaviours
Time frame: Baseline and 12 months.
SBGM practices
Time frame: 1st, 2nd, 3rd, 6th, 12th months.
Glycaemic control
Time frame: Baseline, 3rd,6th, and 12th months.
Weight and waist circumference
Time frame: Baseline, 3rd, 6th, and 12th months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2016.
- Derived from this study: PubMed 31621640Abu-Saad K, Murad H, Barid R, Olmer L, Ziv A, Younis-Zeidan N, Kaufman-Shriqui V, Gillon-Keren M, Rigler S, Berchenko Y, Kalter-Leibovici O. Development and Efficacy of an Electronic, Culturally Adapted Lifestyle Counseling Tool for Improving Diabetes-Related Dietary Knowledge: Randomized Controlled Trial Among Ethnic Minority Adults With Type 2 Diabetes Mellitus. J Med Internet Res. 2019 Oct 16;21(10):e13674. doi: 10.2196/13674.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ofra Kalter-Leibovici, M.D. principal investigator
Sheba Medical Center, the Gertner Institute for Epidemiology & Health Policy Research
Kathleen Abu-Saad, Ph.D. principal investigator
Gertner Institute for Epidemiology & Health Policy Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing I-ACE intervention and Standard Lifestyle Advice in people with Type 2 Diabetes Mellitus, run by Ofra Kalter-Leibovici MD at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in lifestyle knowledge (time frame: Baseline, 3rd,6th,12th months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01858506, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2016.