Diabetes Mellitus, Type 2NCT03167866
Effect of Motivation Text Messages on Diabetes Patients
A study testing motivational SMS and informational SMS in people with Diabetes Mellitus, Type 2, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
The investigators will examine the influence of increasing motivation on healthy lifestyle and glycemic control in diabetes patients. Participants will be randomized to two groups, the control group gets informational text message and the intervention group gets motivational SMS. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- motivational SMS and informational SMS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jun 2017to 1 Dec 2020
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Uncontrolled DM 2 patients (HbA1c > 8%)
- Know to read (Hebrew or Arabic)
- Have a cellular phone
- Can sign informed consent.
Who cannot join
- A life expectancy of less than one year
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Influence of Motivational Text Messages on Glycemic Control and Healthy Lifestyle Choices in Patients With Diabetes
The investigators will examine the influence of increasing motivation on healthy lifestyle and glycemic control in diabetes patients. Participants will be randomized to two groups, the control group gets informational text message and the intervention group gets motivational SMS. The patients get a weekly text message and after 26 weeks the HbA1c and quality of life will be assessed.
Read the detailed description
The investigators will examine the influence of increasing motivation on healthy lifestyle and glycemic control in diabetes patients. Participants will provide demographic and clinical information, fill human value questionnaires and quality of life questionnaires and decide on personal lifestyle-improvement goals. They will then be randomized to one of two groups: the control group gets informational text message and the intervention group gets motivational text message. The patients get a weekly text message and after 26 weeks we will check the HbA1c and quality of life. The text message will be personalized by including personal details acquired by a questionnaire. They will provide demographic and clinical information.
In addition, the influence of demographic characters and related DM character on the benefit of the motivational SMS will be assessed.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- motivational SMS, informational SMS
- 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.
motivational SMSBehavioural
the participant receives a weekly text message that is aimed to increase motivation
informational SMSBehavioural
the participant a weekly text message that is provides information on improving lifestyle
| Study group | Role | What they receive |
|---|---|---|
| control group | Placebo comparator | DM patients who receive a weekly informational Short Message Service (SMS) by phone for 26 weeks. informational SMS Receives: Behavioral: informational SMS |
| test group | Experimental | DM patients who receive a weekly motivational Short Message Service (SMS) for 26 weeks. motivational SMS Receives: Behavioral: motivational SMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c levels at 6 months from beginning of messages
Blood HbA1c levels are reflective of how well diabetes is controlled
Measured: at 6 months from beginning of study
Secondary outcomes (1)
Diabetes Quality of Life questionnaire
To design and test the reliability and validity of a brief treatment
Measured: at 6 months from beginning of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2017
- Study start1 Jun 2017 (estimated)
- Primary completion1 Dec 2019 (estimated)
- Study completion1 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Irit Hochberg, MD/PhD, Principal investigator, Rambam Healthcare Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03167866
- Sponsor's protocol ID
- 66666
- Status last verified
- May 2017
- First submitted
- 26 Apr 2017
- Last updated
- 30 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Text message program improves outcomes, decreases ED utilization among ED patients with poorly controlled diabetes. ED Manag. 2014 Feb;26(2):20-3.
PubMed 24505864Reinhardt JA, van der Ploeg HP, Grzegrzulka R, Timperley JG. lmplementing lifestyle change through phone-based motivational interviewing in rural-based women with previous gestational diabetes mellitus. Health Promot J Austr. 2012 Apr;23(1):5-9. doi: 10.1071/he12005.
PubMed 22730940Arora S, Peters AL, Agy C, Menchine M. A mobile health intervention for inner city patients with poorly controlled diabetes: proof-of-concept of the TExT-MED program. Diabetes Technol Ther. 2012 Jun;14(6):492-6. doi: 10.1089/dia.2011.0252. Epub 2012 Apr 23.
PubMed 22524591Hochberg I, Feraru G, Kozdoba M, Mannor S, Tennenholtz M, Yom-Tov E. Encouraging Physical Activity in Patients With Diabetes Through Automatic Personalized Feedback via Reinforcement Learning Improves Glycemic Control. Diabetes Care. 2016 Apr;39(4):e59-60. doi: 10.2337/dc15-2340. Epub 2016 Jan 28. No abstract available.
PubMed 26822328Ramachandran A, Snehalatha C, Ram J, Selvam S, Simon M, Nanditha A, Shetty AS, Godsland IF, Chaturvedi N, Majeed A, Oliver N, Toumazou C, Alberti KG, Johnston DG. Effectiveness of mobile phone messaging in prevention of type 2 diabetes by lifestyle modification in men in India: a prospective, parallel-group, randomised controlled trial. Lancet Diabetes Endocrinol. 2013 Nov;1(3):191-8. doi: 10.1016/S2213-8587(13)70067-6. Epub 2013 Sep 11.
PubMed 24622367
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Motivational Text Messages on Glycemic Control and Healthy Lifestyle Choices in Patients With Diabetes
- ClinicalTrials.gov ID
- NCT03167866
- Acronym / sponsor ID
- 66666
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- 1 Jun 2017 (estimated)
- Primary completion
- 1 Dec 2019 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 30 May 2017 (actual)
- 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.
The investigators will examine the influence of increasing motivation on healthy lifestyle and glycemic control in diabetes patients. Participants will be randomized to two groups, the control group gets informational text message and the intervention group gets motivational SMS. The patients get a weekly text message and after 26 weeks the HbA1c and quality of life will be assessed.
Detailed description
The investigators will examine the influence of increasing motivation on healthy lifestyle and glycemic control in diabetes patients. Participants will provide demographic and clinical information, fill human value questionnaires and quality of life questionnaires and decide on personal lifestyle-improvement goals. They will then be randomized to one of two groups: the control group gets informational text message and the intervention group gets motivational text message. The patients get a weekly text message and after 26 weeks we will check the HbA1c and quality of life. The text message will be personalized by including personal details acquired by a questionnaire. They will provide demographic and clinical information.
In addition, the influence of demographic characters and related DM character on the benefit of the motivational SMS will be assessed.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Placebo comparator | Behavioral: informational SMSDM patients who receive a weekly informational Short Message Service (SMS) by phone for 26 weeks. informational SMS |
| test group | Experimental | Behavioral: motivational SMSDM patients who receive a weekly motivational Short Message Service (SMS) for 26 weeks. motivational SMS |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Uncontrolled DM 2 patients (HbA1c > 8%)
- Know to read (Hebrew or Arabic)
- Have a cellular phone
- Can sign informed consent.
Key exclusion criteria (1 listed)
- A life expectancy of less than one year
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 |
|---|---|---|
| motivational SMSthe participant receives a weekly text message that is aimed to increase motivation | Behavioural | test group |
| informational SMSthe participant a weekly text message that is provides information on improving lifestyle | Behavioural | control group |
Primary outcome
HbA1c levels at 6 months from beginning of messages
Time frame: at 6 months from beginning of study
Blood HbA1c levels are reflective of how well diabetes is controlled
1 secondary outcome
Diabetes Quality of Life questionnaire
Time frame: at 6 months from beginning of study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
- Background: PubMed 24505864Text message program improves outcomes, decreases ED utilization among ED patients with poorly controlled diabetes. ED Manag. 2014 Feb;26(2):20-3.
- Background: PubMed 22730940Reinhardt JA, van der Ploeg HP, Grzegrzulka R, Timperley JG. lmplementing lifestyle change through phone-based motivational interviewing in rural-based women with previous gestational diabetes mellitus. Health Promot J Austr. 2012 Apr;23(1):5-9. doi: 10.1071/he12005.
- Background: PubMed 22524591Arora S, Peters AL, Agy C, Menchine M. A mobile health intervention for inner city patients with poorly controlled diabetes: proof-of-concept of the TExT-MED program. Diabetes Technol Ther. 2012 Jun;14(6):492-6. doi: 10.1089/dia.2011.0252. Epub 2012 Apr 23.
- Background: PubMed 26822328Hochberg I, Feraru G, Kozdoba M, Mannor S, Tennenholtz M, Yom-Tov E. Encouraging Physical Activity in Patients With Diabetes Through Automatic Personalized Feedback via Reinforcement Learning Improves Glycemic Control. Diabetes Care. 2016 Apr;39(4):e59-60. doi: 10.2337/dc15-2340. Epub 2016 Jan 28. No abstract available.
- Background: PubMed 24622367Ramachandran A, Snehalatha C, Ram J, Selvam S, Simon M, Nanditha A, Shetty AS, Godsland IF, Chaturvedi N, Majeed A, Oliver N, Toumazou C, Alberti KG, Johnston DG. Effectiveness of mobile phone messaging in prevention of type 2 diabetes by lifestyle modification in men in India: a prospective, parallel-group, randomised controlled trial. Lancet Diabetes Endocrinol. 2013 Nov;1(3):191-8. doi: 10.1016/S2213-8587(13)70067-6. Epub 2013 Sep 11.
- Individual participant dataSharing planned: No
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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.
Irit Hochberg, MD/PhD principal investigator
Rambam Healthcare Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing motivational SMS and informational SMS in people with Diabetes Mellitus, Type 2, run by Rambam Health Care Campus 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 1 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: status not confirmed, as of the sponsor's last update on 30 May 2017. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Irit Hochberg, MD/PhD (972-4-7772150, i_hochberg@rambam.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c levels at 6 months from beginning of messages (time frame: at 6 months from beginning of study). 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 NCT03167866, which also lists 5 linked publications.
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 30 May 2017.