Type 2 DiabetesmHealthNCT04243174
The Use of Short SMS Messaging With Type 2 Diabetes (T2DM)
A study testing SMS Messaging in people with Type 2 Diabetes and Physical Exercise, run by University of Nottingham at 1 site in Saudi Arabia.
Trial summary
Physical activity (PA) can play a vital and an independent role in type 2 diabetes (T2DM) management care. Health research studies have shown evidence that PA can improve glycaemic control and glucose levels. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes, Physical Exercise
- What is being tested?
- SMS Messaging
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 23 Jan 2020to 30 Mar 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinician diagnosis of T2DM.
- Over 18 years of age.
- Possession of a cell phone with text messaging capability.
- Ability to read and understand Arabic.
Who cannot join
- Treatment with insulin adjustment
- Unable to understand the study requirements or give informed consent.
- Visual impairment.
- Any diabetes-related complications such as neuropathy or retinopathy that preclude ability to increase PA.
- Clinician concern (physicians will be asked to confirm whether eligible participants can be medically capable of performing PA at the recommended level advised by National Institute for Health and Care Excellence (NICE, 2013).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Use of Mobile Phone Messaging as a Behavioural Intervention to Increase Physical Activity in Adults With T2DM in Saudi Arabia
Physical activity (PA) can play a vital and an independent role in type 2 diabetes (T2DM) management care. Health research studies have shown evidence that PA can improve glycaemic control and glucose levels. PA is first line of self-care management recommended to patients with T2DM and most patients fail to perform the regular PA. It is always important for health providers to find better methods in encouraging and incentivizing PA in T2DM patients. Mobile phone messaging-based interventions have been shown to strengthen the delivery of health information and self-care management programs.
Read the detailed description
Studies have employed this as a tool for promoting T2DM self-care management interventions such as physical activity, glucose monitoring, medication adherence and nutrition. Despite the increasing number of these interventions globally, the effectiveness of mobile phone messaging-based interventions in Saudi Arabia context remains inconclusive and inconsistent. There is limited research conducted in this region. Therefore, there is a need for more studies to show evidence to ascertain the effectiveness of using mobile phone messaging to promote PA in T2DM patients in the context of Saudi Arabia.
- Conditions
- Type 2 Diabetes, Physical Exercise
- Being tested
- SMS Messaging
- Medical subject headings
- Diabetes Mellitus, Type 2, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMS MessagingBehavioural
Patients with type 2 diabetes will be recruited and will start receiving short SMS messages about physical activity, encouraging them to be more active and help them to build a healthy life style routine.
| Study group | Role | What they receive |
|---|---|---|
| SMS Messages | Other | Patients with type 2 diabetes will be recruited and will start receiving short SMS messages about physical activity, encouraging them to be more active and help them to build a healthy life style routine. Receives: Behavioral: SMS Messaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of mobile phone text messaging intervention for people with T2DM: Number of Participants recruited, completed the study, dropped out
Number of Participants recruited, completed the study, dropped out.
Measured: Six weeks
Secondary outcomes (5)
Acceptability of mobile phone text messaging intervention for people with T2DM: Qualitative interviews
Qualitative interviews will be undertaken with study participants and healthcare professionals (HCPs) to explore: satisfaction with the intervention; barriers and facilitators of the intervention; perceived impact of the intervention, and potential changes and necessary improvements.
Measured: Six weeks
Clinical measurements pre and after the intervention
Is glycated haemoglobin (HbA1c) sensitive to change when using SMS text messaging for physical activity promotion in the care of T2DM
Measured: 3 months
Clinical measurements pre and after the intervention
Is the body mass index (BMI) in kg/m^2 sensitive to change when using SMS text messaging for physical activity promotion in the care of T2DM
Measured: 3 months
Behaviour change outcome
Is self-efficacy for physical activity (SEPA) questionnaire sensitive to change when using SMS text messaging for physical activity promotion in the care of T2DM. The total score is calculated by finding the sum of the all items. The total score ranges between 10 and 40, with a higher score indicating more self-efficacy.
Measured: Six weeks
Self-report questionnaire (International Physical Activity Questionnaire - IPAQ)
To compare levels of physical activity (PA) before and after an intervention, IPAQ is used to assess moderate-to-vigorous physical activity in adult people. Categorical Score- three levels of physical activity are proposed:
- Low
- No activity is reported.
- Moderate
- More days of vigorous activity of at least 20 minutes per day.
- High
- Vigorous-intensity activity on at least 3 days and accumulating at least 1500MET-minutes/week.
Measured: Six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2020
- Study start23 Jan 2020
- Primary completion1 Mar 2020
- Study completion30 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single Group where they start receiving SMS messages about the importance of physical activity and its benefits on T2DM.
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Holly Blake, University of Nottingham
- Investigators
- Dr.Holly Blake, PhD, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04243174
- Sponsor's protocol ID
- 10
- Acronym
- mHealth
- Status last verified
- Aug 2021
- First submitted
- 19 Nov 2019
- Last updated
- 27 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After the study has been conducted and completed.
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Mobile Phone Messaging as a Behavioural Intervention to Increase Physical Activity in Adults With T2DM in Saudi Arabia
- ClinicalTrials.gov ID
- NCT04243174
- Acronym / sponsor ID
- mHealth / 10
- Conditions
- Type 2 Diabetes, Physical Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- 23 Jan 2020 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 28 Jan 2020 (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.
Physical activity (PA) can play a vital and an independent role in type 2 diabetes (T2DM) management care. Health research studies have shown evidence that PA can improve glycaemic control and glucose levels. PA is first line of self-care management recommended to patients with T2DM and most patients fail to perform the regular PA. It is always important for health providers to find better methods in encouraging and incentivizing PA in T2DM patients. Mobile phone messaging-based interventions have been shown to strengthen the delivery of health information and self-care management programs.
Detailed description
Studies have employed this as a tool for promoting T2DM self-care management interventions such as physical activity, glucose monitoring, medication adherence and nutrition. Despite the increasing number of these interventions globally, the effectiveness of mobile phone messaging-based interventions in Saudi Arabia context remains inconclusive and inconsistent. There is limited research conducted in this region. Therefore, there is a need for more studies to show evidence to ascertain the effectiveness of using mobile phone messaging to promote PA in T2DM patients in the context of Saudi Arabia.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Group where they start receiving SMS messages about the importance of physical activity and its benefits on T2DM.
| Arm | Type | Receives |
|---|---|---|
| SMS Messages | Other | Behavioral: SMS MessagingPatients with type 2 diabetes will be recruited and will start receiving short SMS messages about physical activity, encouraging them to be more active and help them to build a healthy life style routine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinician diagnosis of T2DM.
- Over 18 years of age.
- Possession of a cell phone with text messaging capability.
- Ability to read and understand Arabic.
Key exclusion criteria (5 listed)
- Treatment with insulin adjustment
- Unable to understand the study requirements or give informed consent.
- Visual impairment.
- Any diabetes-related complications such as neuropathy or retinopathy that preclude ability to increase PA.
- Clinician concern (physicians will be asked to confirm whether eligible participants can be medically capable of performing PA at the recommended level advised by National Institute for Health and Care Excellence (NICE, 2013).
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 |
|---|---|---|
| SMS MessagingPatients with type 2 diabetes will be recruited and will start receiving short SMS messages about physical activity, encouraging them to be more active and help them to build a healthy life style routine. | Behavioural | SMS Messages |
Primary outcome
Feasibility of mobile phone text messaging intervention for people with T2DM: Number of Participants recruited, completed the study, dropped out
Time frame: Six weeks
Number of Participants recruited, completed the study, dropped out.
5 secondary outcomes
Acceptability of mobile phone text messaging intervention for people with T2DM: Qualitative interviews
Time frame: Six weeks
Clinical measurements pre and after the intervention
Time frame: 3 months
Clinical measurements pre and after the intervention
Time frame: 3 months
Behaviour change outcome
Time frame: Six weeks
Self-report questionnaire (International Physical Activity Questionnaire - IPAQ)
Time frame: Six weeks
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 27 Aug 2021.
- Individual participant dataSharing planned: Yes. After the study has been conducted and completed.
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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.
Dr.Holly Blake, PhD principal investigator
University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SMS Messaging in people with Type 2 Diabetes and Physical Exercise, run by University of Nottingham at 1 site in Saudi Arabia.
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 5 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 27 Aug 2021. 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 Saudi Arabia. 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?
Feasibility of mobile phone text messaging intervention for people with T2DM: Number of Participants recruited, completed the study, dropped out (time frame: Six weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Aug 2021.