Type 2 DiabetesNCT05641402
Evidence-based Text Messages to Target Diet and Physical Activity
A study testing Text messages in people with Type 2 Diabetes, run by University of Manchester at 1 site in United Kingdom.
Trial summary
This research aims to develop a bank of text messages based on behaviour change techniques targeting specific diet and physical activity behaviours in people with type 2 diabetes Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Text messages
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Jul 2022to 30 Jun 2024
- 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
- Participant is willing and able to give informed consent for participation in the study.
- Male or female, aged 18 years or above.
- A diagnosis of type 2 diabetes.
- Has access to a mobile-phone (shared access is allowed with permission of phone owner)
- Able to use a mobile phone, if necessary with help, to send or retrieve brief messages (including text-messages or messaging within smartphone applications).
- Participant is willing and able to give informed consent for participation in the study.
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- Aged 18 years or above.
- A diagnosis of type 2 diabetes.
- Has access to a mobile-phone (shared access is allowed with permission of phone owner)
- Able to use a mobile phone, if necessary with help, to send or retrieve brief messages (including text-messages).
Who cannot join
- Moved out of England prior to taking part in the study
- For the anticipated acceptability survey and experienced acceptability study
- Within three months of a hospital admission for hyperglycaemia or hypoglycaemia.
- Pregnant or within three months post-partum by self-report
- Underweight (For anticipated acceptability this will be by self-report, for experienced acceptability BMI<18.5)
- Historical or current diagnosis of an eating disorder Prescribed insulin for their diabetes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Developing Evidence-based Text Messages to Target Diet and Physical Activity Behaviour for People with Type 2 Diabetes Mellitus
This research aims to develop a bank of text messages based on behaviour change techniques targeting specific diet and physical activity behaviours in people with type 2 diabetes
Read the detailed description
Aim: To develop text messages that help people with type 2 diabetes (T2D) improve their diet and level of physical activity
What is known:
Following diet and physical activity advice helps to reduce the risk of health problems for people with T2D
Just telling people about a healthy diet, or ideal levels of physical activity may not change what someone does day-to-day. Many people need support to change health behaviours
Techniques designed to help people change their behaviour, such as setting goals, can help people act
Text messages can be sent to large numbers of people, for a low cost
For the best chance of success, it is important that the messages are a) acceptable to the people receiving them and b) use techniques to help people to make changes
How the investigators are going to achieve their aim:
When asking someone to follow a healthy diet or do more physical activity, this could refer to changing lots of different behaviours such as eating less sugar or less fat and walking each day. The investigators invited people with type 2 diabetes, doctors, nurses, dietitians, and researchers to take part in a workshop to work out which behaviours are the most important ones for people with type 2 diabetes to do. The investigators have also looked at previous research and found techniques that have helped people with type 2 diabetes change their diet and levels of activity.
The investigators will now follow four steps to develop the messages:
- Twelve to fifteen people with type 2 diabetes will take part in online focus groups to provide feedback about the target behaviours and guide the development of the text message system
- Ten to twenty researchers will take part in a workshop. They will write messages using the techniques that have worked in previous research to target important behaviours for people with type 2 diabetes. They will then complete a survey to report whether the messages are good examples of the techniques.
- Sixty people with type 2 diabetes will complete a survey to tell us whether they like and understand the messages and how useful they think they would be.
- Forty people with type 2 diabetes will receive the messages for up to 3 months and take part in an interview over the phone to help us understand their experiences.
Patient and Public Involvement and Engagement (PPIE) This research has been developed with a PPIE group. Our PPIE co-applicant and PPIE group will be involved in key decisions and review any materials being sent to people with type 2 diabetes.
What the investigators will do with the findings
Explore how these messages can become part of routine National Health Service (NHS) care. The findings will be used together with work our team are doing looking at sending out text messages to help people with type 2 diabetes take their medication.
Findings will also be publicised through databases of people interested in research, diabetes charities, community groups, places of worship and publications.
- Conditions
- Type 2 Diabetes
- Being tested
- Text messages
- 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.
Text messagesOther
Text messages based on behaviour change techniques
| Study group | Role | What they receive |
|---|---|---|
| Experienced acceptability study | Other | The final study in this research will involve people with type 2 diabetes receiving the text messages Receives: Other: Text messages |
What is being measured
The primary outcome is the main question the study is designed to answer.
Experienced Acceptability of the text messages for people with type 2 diabetes
Assessed through interviews following receiving the text messages
Measured: 3.5 months
Secondary outcomes (2)
Anticipated Acceptability
Assessed through online survey
Measured: 60 minutes
Rating of fidelity to intended behaviour change technique
How well the text messages represent their intended behaviour change technique. For each behaviour change technique, participants will be presented with the title and description of the technique from the Behaviour change Technique (BCT) v1 taxonomy (Michie et al., 2013, doi: 10.1007/s12160-013-9486-6), and then sample messages. For each message participants will be asked "How well does this message reflect the [specific technique] as defined above?". Answers were given on a 10-point scale anchored with 1 (not very well) to 10 (very well).
This scale has been used in our previous work developing text messages (Bartlett et al., 2020, doi: 10.2196/15989)
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2022
- Study start14 Jul 2022
- Primary completion23 Nov 2023
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by University of ManchesterThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oxford, Manchester University NHS Foundation Trust, Northern Care Alliance NHS Foundation Trust
- Responsible party
- Principal investigator, Yvonne Kiera Bartlett, University of Manchester
- Investigators
- Kiera Bartlett, PhD, Principal investigator, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05641402
- Sponsor's protocol ID
- NIHR202832
- Status last verified
- Jan 2025
- First submitted
- 17 Nov 2022
- Last updated
- 20 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Subject to participant consent. Plan to upload the deidentified survey data with codebook Will explore uploading deidentified transcripts if a relevant database is found
Publications
Michie S, Richardson M, Johnston M, Abraham C, Francis J, Hardeman W, Eccles MP, Cane J, Wood CE. The behavior change technique taxonomy (v1) of 93 hierarchically clustered techniques: building an international consensus for the reporting of behavior change interventions. Ann Behav Med. 2013 Aug;46(1):81-95. doi: 10.1007/s12160-013-9486-6.
PubMed 23512568Bartlett YK, Farmer A, Rea R, French DP. Use of Brief Messages Based on Behavior Change Techniques to Encourage Medication Adherence in People With Type 2 Diabetes: Developmental Studies. J Med Internet Res. 2020 May 13;22(5):e15989. doi: 10.2196/15989.
PubMed 32401214
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing Evidence-based Text Messages to Target Diet and Physical Activity Behaviour for People with Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT05641402
- Acronym / sponsor ID
- NIHR202832
- Conditions
- Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Collaborators
- University of Oxford, Manchester University NHS Foundation Trust, Northern Care Alliance NHS Foundation Trust
- Study start
- 14 Jul 2022 (actual)
- Primary completion
- 23 Nov 2023 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 7 Dec 2022 (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.
This research aims to develop a bank of text messages based on behaviour change techniques targeting specific diet and physical activity behaviours in people with type 2 diabetes
Detailed description
Aim: To develop text messages that help people with type 2 diabetes (T2D) improve their diet and level of physical activity
What is known:
Following diet and physical activity advice helps to reduce the risk of health problems for people with T2D
Just telling people about a healthy diet, or ideal levels of physical activity may not change what someone does day-to-day. Many people need support to change health behaviours
Techniques designed to help people change their behaviour, such as setting goals, can help people act
Text messages can be sent to large numbers of people, for a low cost
For the best chance of success, it is important that the messages are a) acceptable to the people receiving them and b) use techniques to help people to make changes
How the investigators are going to achieve their aim:
When asking someone to follow a healthy diet or do more physical activity, this could refer to changing lots of different behaviours such as eating less sugar or less fat and walking each day. The investigators invited people with type 2 diabetes, doctors, nurses, dietitians, and researchers to take part in a workshop to work out which behaviours are the most important ones for people with type 2 diabetes to do. The investigators have also looked at previous research and found techniques that have helped people with type 2 diabetes change their diet and levels of activity.
The investigators will now follow four steps to develop the messages:
- Twelve to fifteen people with type 2 diabetes will take part in online focus groups to provide feedback about the target behaviours and guide the development of the text message system
- Ten to twenty researchers will take part in a workshop. They will write messages using the techniques that have worked in previous research to target important behaviours for people with type 2 diabetes. They will then complete a survey to report whether the messages are good examples of the techniques.
- Sixty people with type 2 diabetes will complete a survey to tell us whether they like and understand the messages and how useful they think they would be.
- Forty people with type 2 diabetes will receive the messages for up to 3 months and take part in an interview over the phone to help us understand their experiences.
Patient and Public Involvement and Engagement (PPIE) This research has been developed with a PPIE group. Our PPIE co-applicant and PPIE group will be involved in key decisions and review any materials being sent to people with type 2 diabetes.
What the investigators will do with the findings
Explore how these messages can become part of routine National Health Service (NHS) care. The findings will be used together with work our team are doing looking at sending out text messages to help people with type 2 diabetes take their medication.
Findings will also be publicised through databases of people interested in research, diabetes charities, community groups, places of worship and publications.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experienced acceptability study | Other | Other: Text messagesThe final study in this research will involve people with type 2 diabetes receiving the text messages |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Participant is willing and able to give informed consent for participation in the study.
- Male or female, aged 18 years or above.
- A diagnosis of type 2 diabetes.
- Has access to a mobile-phone (shared access is allowed with permission of phone owner)
- Able to use a mobile phone, if necessary with help, to send or retrieve brief messages (including text-messages or messaging within smartphone applications).
Key exclusion criteria (6 listed)
- Moved out of England prior to taking part in the study
- For the anticipated acceptability survey and experienced acceptability study
- Within three months of a hospital admission for hyperglycaemia or hypoglycaemia.
- Pregnant or within three months post-partum by self-report
- Underweight (For anticipated acceptability this will be by self-report, for experienced acceptability BMI<18.5)
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 |
|---|---|---|
| Text messagesText messages based on behaviour change techniques | Other | Experienced acceptability study |
Primary outcome
Experienced Acceptability of the text messages for people with type 2 diabetes
Time frame: 3.5 months
Assessed through interviews following receiving the text messages
2 secondary outcomes
Anticipated Acceptability
Time frame: 60 minutes
Rating of fidelity to intended behaviour change technique
Time frame: 60 minutes
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 20 Jan 2025.
- Background: PubMed 23512568Michie S, Richardson M, Johnston M, Abraham C, Francis J, Hardeman W, Eccles MP, Cane J, Wood CE. The behavior change technique taxonomy (v1) of 93 hierarchically clustered techniques: building an international consensus for the reporting of behavior change interventions. Ann Behav Med. 2013 Aug;46(1):81-95. doi: 10.1007/s12160-013-9486-6.
- Background: PubMed 32401214Bartlett YK, Farmer A, Rea R, French DP. Use of Brief Messages Based on Behavior Change Techniques to Encourage Medication Adherence in People With Type 2 Diabetes: Developmental Studies. J Med Internet Res. 2020 May 13;22(5):e15989. doi: 10.2196/15989.
- Individual participant dataSharing planned: Yes. Subject to participant consent. Plan to upload the deidentified survey data with codebook Will explore uploading deidentified transcripts if a relevant database is found
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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.
Kiera Bartlett, PhD principal investigator
University of Manchester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Text messages in people with Type 2 Diabetes, run by University of Manchester at 1 site in United Kingdom.
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 10 inclusion and 6 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 20 Jan 2025. 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 United Kingdom. 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?
Experienced Acceptability of the text messages for people with type 2 diabetes (time frame: 3.5 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 NCT05641402, which also lists 2 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 20 Jan 2025.