Pre-diabetesNCT02919397
Motivational Instant Messaging and E-diabetes Prevention Programme for High Risk of Type 2 Diabetes
A study testing Wearable technology, Diabetes Prevention Programme educational material and Motivational messaging in people with Pre-diabetes, run by King's College London.
Trial summary
The overall aim of this feasibility trial is to assess the effectiveness of a wearable technology and an e-diabetes prevention programme delivered via a smartphone application, including motivational messaging, in reducing weight and increasing physical activity in people at risk of developing type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pre-diabetes
- What is being tested?
- Wearable technology, Diabetes Prevention Programme educational material and Motivational messaging
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2016to 12 Jul 2018
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- HbA1c between 42 and 47 mmol/mol
- BMI≥25 kg/m²
- Fluent in conversational English
- Permanent resident in Lambeth, Southwark or Lewisham
- Ownership of a smartphone (iPhone or Android only) for communication defined as logging on at least once/day to the internet
- Ambulatory.
Who cannot join
- Known diabetes
- Pregnancy or planning pregnancy during the duration of the study
- Severe mental illness (severe depression, psychosis, bipolar affective disorder, dementia, learning difficulties, substance problem use or dependence)
- Severe physical disability e.g. that would prevent any increased uptake of physical exercise
- Advanced active disease such as cancer or heart failure
- Any other condition which requires glucose altering drugs
Show all 9Show fewer
- Morbid obesity (BMI ≥50 kg/m²)
- Current participation in a weight loss programme.
- When in doubt the investigators will seek the GP opinion and approval.
About this study
Official title: Effectiveness of Integrating Motivational Instant Messaging Into an E-diabetes Prevention Programme in People at High Risk of Type 2 Diabetes: a Prospective, Parallel-group, Randomised Controlled Trial (Diabetes Stopwatch)
The overall aim of this feasibility trial is to assess the effectiveness of a wearable technology and an e-diabetes prevention programme delivered via a smartphone application, including motivational messaging, in reducing weight and increasing physical activity in people at risk of developing type 2 diabetes.
Read the detailed description
The study will examine whether a wearable technology, combined with biofeedback, motivational messaging and an e-diabetes prevention programme, is effective in reducing weight and increasing physical activity after 12 months.
The intervention will consist of a wearable technology and a smartphone application made available for a 12 month period. 22 online multimedia sessions targeting diet, physical activity and mental resilience delivered via the smartphone application. Motivational messaging based on the diabetes prevention module content and biofeedback will be sent to participants via the application.
The control group will receive the wearable technology and will have access to a smartphone application detailing their activity. Participants will be directed to the same educational material as is made available via the multimedia sessions, but will not receive motivational messages.
- Conditions
- Pre-diabetes
- Being tested
- Wearable technology, Diabetes Prevention Programme educational material, Motivational messaging
- Medical subject headings
- Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wearable technologyDevice
Buddi wearable technology will record activity levels, participants will access activity data through smartphone application
Diabetes Prevention Programme educational materialBehavioural
Educational material accessed through smartphone application
Motivational messagingBehavioural
Messages sent via smartphone application
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | If participants are allocated to the intervention group, participants will receive the wearable technology and access to the smartphone application. Motivational messages based on diabetes prevention programme content, and biofeedback messages based on physical activity data provided via the wearable technology, will be received by participants via the application. The diabetes prevention programme educational material will be available via the application. Receives: Device: Wearable technology; Behavioral: Diabetes Prevention Programme educational material; Behavioral: Motivational messaging |
| Control | Active comparator | If participants are allocated to the control group, participants will receive the wearable technology and will be able to access their activity data via the smartphone application. Participants will also have have access to the diabetes prevention programme educational material via the application. Participants will not receive motivational messages related to the education content or activity data. Receives: Device: Wearable technology; Behavioral: Diabetes Prevention Programme educational material |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity (average steps per day)
Average steps taken per day from 7 days wear measured using the Buddi wearable technology, which will be worn 24 hours per day for 7 days
Measured: 7 days
Weight (kg)
Measured in light clothing, without shoes, on the a Class 3 Tanita SC240 weighing digital scale to 0.01 kg for weight
Measured: At 12 month follow-up appointment
Secondary outcomes (11)
HbA1c (mmol/mol)
Measured: At 12 month follow-up appointment
Height (cm)
Measured: At 12 month follow-up appointment
BMI (kg/m^2)
Measured: At 12 month follow-up appointment
Waist circumference (cm)
Measured: At 12 month follow-up appointment
Hip circumference (cm)
Measured: At 12 month follow-up appointment
Total cholesterol (mmol/L)
Measured: At 12 month follow-up appointment
High density lipoprotein cholesterol (mmol/L)
Measured: At 12 month follow-up appointment
Low density lipoprotein cholesterol (mmol/L)
Measured: At 12 month follow-up appointment
Systolic blood pressure (mmHg)
Measured: At 12 month follow-up appointment
Diastolic blood pressure (mmHg)
Measured: At 12 month follow-up appointment
Sleep duration (average hours per night)
The Buddi wearable technology will be worn for 24 hours per day. Therefore, during sleeping hours participant activity will be measured and duration of sleep can be calculated. Participants will wear the Buddi device for 7 days, and the average number of hours sleep per night will be calculated.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2016 (estimated)
- Study start1 Oct 2016
- Primary completion25 May 2018
- Study completion12 Jul 2018
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 Pre-diabetesStudies of the same condition, open and under way.
- More trials run by King's College LondonThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Khalida Ismail, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02919397
- Sponsor's protocol ID
- 197384
- Status last verified
- Mar 2018
- First submitted
- 20 Sep 2016
- Last updated
- 9 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Staite E, Bayley A, Al-Ozairi E, Stewart K, Hopkins D, Rundle J, Basudev N, Mohamedali Z, Ismail K. A Wearable Technology Delivering a Web-Based Diabetes Prevention Program to People at High Risk of Type 2 Diabetes: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2020 Jul 15;8(7):e15448. doi: 10.2196/15448.
PubMed 32459651
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Integrating Motivational Instant Messaging Into an E-diabetes Prevention Programme in People at High Risk of Type 2 Diabetes: a Prospective, Parallel-group, Randomised Controlled Trial (Diabetes Stopwatch)
- ClinicalTrials.gov ID
- NCT02919397
- Acronym / sponsor ID
- 197384
- Conditions
- Pre-diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 25 May 2018 (actual)
- Study completion
- 12 Jul 2018 (actual)
- First posted
- 29 Sep 2016 (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.
The overall aim of this feasibility trial is to assess the effectiveness of a wearable technology and an e-diabetes prevention programme delivered via a smartphone application, including motivational messaging, in reducing weight and increasing physical activity in people at risk of developing type 2 diabetes.
Detailed description
The study will examine whether a wearable technology, combined with biofeedback, motivational messaging and an e-diabetes prevention programme, is effective in reducing weight and increasing physical activity after 12 months.
The intervention will consist of a wearable technology and a smartphone application made available for a 12 month period. 22 online multimedia sessions targeting diet, physical activity and mental resilience delivered via the smartphone application. Motivational messaging based on the diabetes prevention module content and biofeedback will be sent to participants via the application.
The control group will receive the wearable technology and will have access to a smartphone application detailing their activity. Participants will be directed to the same educational material as is made available via the multimedia sessions, but will not receive motivational messages.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Wearable technology, Behavioral: Diabetes Prevention Programme educational material, Behavioral: Motivational messagingIf participants are allocated to the intervention group, participants will receive the wearable technology and access to the smartphone application. Motivational messages based on diabetes prevention programme content, and biofeedback messages based on physical activity data provided via the wearable technology, will be received by participants via the application. The diabetes prevention programme educational material will be available via the application. |
| Control | Active comparator | Device: Wearable technology, Behavioral: Diabetes Prevention Programme educational materialIf participants are allocated to the control group, participants will receive the wearable technology and will be able to access their activity data via the smartphone application. Participants will also have have access to the diabetes prevention programme educational material via the application. Participants will not receive motivational messages related to the education content or activity data. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- HbA1c between 42 and 47 mmol/mol
- BMI≥25 kg/m²
- Fluent in conversational English
- Permanent resident in Lambeth, Southwark or Lewisham
- Ownership of a smartphone (iPhone or Android only) for communication defined as logging on at least once/day to the internet
Key exclusion criteria (9 listed)
- Known diabetes
- Pregnancy or planning pregnancy during the duration of the study
- Severe mental illness (severe depression, psychosis, bipolar affective disorder, dementia, learning difficulties, substance problem use or dependence)
- Severe physical disability e.g. that would prevent any increased uptake of physical exercise
- Advanced active disease such as cancer or heart failure
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 |
|---|---|---|
| Wearable technologyBuddi wearable technology will record activity levels, participants will access activity data through smartphone application | Device | Control, Intervention |
| Diabetes Prevention Programme educational materialEducational material accessed through smartphone application | Behavioural | Control, Intervention |
| Motivational messagingMessages sent via smartphone application | Behavioural | Intervention |
Primary outcome
Physical activity (average steps per day)
Time frame: 7 days
Average steps taken per day from 7 days wear measured using the Buddi wearable technology, which will be worn 24 hours per day for 7 days
Weight (kg)
Time frame: At 12 month follow-up appointment
Measured in light clothing, without shoes, on the a Class 3 Tanita SC240 weighing digital scale to 0.01 kg for weight
11 secondary outcomes
HbA1c (mmol/mol)
Time frame: At 12 month follow-up appointment
Height (cm)
Time frame: At 12 month follow-up appointment
BMI (kg/m^2)
Time frame: At 12 month follow-up appointment
Waist circumference (cm)
Time frame: At 12 month follow-up appointment
Hip circumference (cm)
Time frame: At 12 month follow-up appointment
Total cholesterol (mmol/L)
Time frame: At 12 month follow-up appointment
High density lipoprotein cholesterol (mmol/L)
Time frame: At 12 month follow-up appointment
Low density lipoprotein cholesterol (mmol/L)
Time frame: At 12 month follow-up appointment
Systolic blood pressure (mmHg)
Time frame: At 12 month follow-up appointment
Diastolic blood pressure (mmHg)
Time frame: At 12 month follow-up appointment
Sleep duration (average hours per night)
Time frame: 7 days
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 9 Aug 2018.
- Derived from this study: PubMed 32459651Staite E, Bayley A, Al-Ozairi E, Stewart K, Hopkins D, Rundle J, Basudev N, Mohamedali Z, Ismail K. A Wearable Technology Delivering a Web-Based Diabetes Prevention Program to People at High Risk of Type 2 Diabetes: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2020 Jul 15;8(7):e15448. doi: 10.2196/15448.
- Individual participant dataSharing planned: Undecided
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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.
Khalida Ismail principal investigator
King's College London
Questions about this trial
What is this clinical trial studying?
A study testing Wearable technology, Diabetes Prevention Programme educational material and Motivational messaging in people with Pre-diabetes, run by King's College London.
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 6 inclusion and 9 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 9 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Physical activity (average steps per day) (time frame: 7 days). The study lists 2 primary outcomes in all. 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 NCT02919397, 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 9 Aug 2018.