DiabetesNCT05203575
Building a Behavioural Intervention Programme to Improve Self-Management of Diabetes
A study testing Fast-forwarding in Cycle 1, Goal-Setting plus Weekly Nudge in Cycle 1 and Fast-forwarding in Cycle 2 in people with Diabetes, run by National University of Singapore at 1 site in Singapore.
Trial summary
Effective control of diabetes requires patients to change their daily behaviour. The investigators propose an intervention programme for behavioural change with two components, targeting motivation and implementation. Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Diabetes
- What is being tested?
- Fast-forwarding in Cycle 1, Goal-Setting plus Weekly Nudge in Cycle 1 and Fast-forwarding in Cycle 2
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 1 siteSingapore
- Study dates
- 28 Mar 2022to 31 Aug 2023
- 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 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 21-70
- Has type 2 diabetes
- Comfortable communicating English
- Uses smartphone app WhatsApp
Who cannot join
- Participants with diagnoses of mental health illnesses
- Participants who are unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Effective control of diabetes requires patients to change their daily behaviour. The investigators propose an intervention programme for behavioural change with two components, targeting motivation and implementation. The motivation component raises the salience of probable patient-specific detrimental future outcomes by 'fast-forwarding' awareness of these outcomes to the present. The implementation component helps patients to set goals and to act based on weekly tips. A factorial design will be used to establish the necessity and sufficiency of the two components on changing mind and guiding behaviour to improve blood glucose level. Individual-level measures of psychological, physical and medical conditions will be shown to drive the heterogenous responses to the two components. Intervention is expanded into two cycles with crossover design to demonstrate how the individual-level measures drive the wear-off, built-up and persistence of the two components. The results of this two-component programme will serve as a basis for systematic synthesis of component-level effectiveness in behavioural intervention research.
Read the detailed description
This behavioural-change-intervention programme will be an online 'single-centre' outpatient randomized controlled trial (RCT) with ten study arms. It will be a two-component intervention consisting of a motivation component of fast-forwarding and an implementation component of goal-setting and weekly nudges. The field intervention will be structured into a two-cycle four-treatment crossover design with four treatment conditions in the first cycle and crossing-over into eight treatment conditions (including one control condition) in the second cycle. In addition to the control group in the study, a group of patients from the Singapore Health Services (SingHealth) Diabetes Registry dataset will be identified using propensity scoring to serve as a 'match-pair' for each study participant. The electronic medical record of this match-pair will provide an additional benchmark of biological measure in addition to that provided by the control group.
The field study will run for 34 weeks, in two cycles of 14 weeks each, with a 2-week transition period between the two cycles. There will also be a 2-week baseline period in which baseline measurements will be taken before the first cycle begins and a 2-week debriefing period where the final measurement will be taken after the end of the second cycle. Measurements will be taken three times: once before Cycle 1 (as the baseline), once between Cycles 1 and 2, and once at the end of Cycle 2. Participants who are assigned to the motivation component of fast-forwarding will receive fast-forwarding immediately after the measurement session and before the cycle. The participants who are randomly assigned to treatment conditions, including the implementation component, will receive a weekly nudge programme with each 14-week cycle. All participants will have access to the resources used to generate the 14-week cycles.
The investigators will measure the following: (i) physiological and medical information related to the progression of diabetes; (ii) diet quality and exercise level; (iii) psychological reactions towards diabetes management; (iv) behavioural change readiness and commitment; and (v) lifestyle (smoking, alcohol consumption, and sleep quality).
- Conditions
- Diabetes
- Being tested
- Fast-forwarding in Cycle 1, Goal-Setting plus Weekly Nudge in Cycle 1, Fast-forwarding in Cycle 2, Goal-Setting plus Weekly Nudge in Cycle 2
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fast-forwarding in Cycle 1Behavioural
The fast-forwarding intervention will consist of a projection of future risk of co-morbidities. A visual projection model will be built using archival data available through the Singapore Diabetes Registry. The projection model will use the current profile of the participant to calculate a risk profile for the participant's potential complications and co-morbidities, which will be presented as a pie chart. The tool will also present alternative scenarios to the participant and visualize how the likelihood of complications or co-morbidities would decrease or increases if his/her habits changed. This will provide the motivational aspect of the intervention.
This intervention takes place during Cycle 1 (first 14 weeks).
Goal-Setting plus Weekly Nudge in Cycle 1Behavioural
The procedure for goal-setting will start with the participant receiving a list of possible goals. The moderator will go through the list with the participant to identify which goals the participant is comfortable with and could reasonably achieve, and to tick off those goals that the participant has already achieved. The participants will choose their own goals. In each subsequent week, the moderator will check-in with the participant and tick off the goal(s) that have been achieved.
Chat groups of 10-15 people will be formed to administer the weekly nudge. The participants will be encouraged to introduce themselves and to interact with each other during each the chat session. Every week for the following 14 weeks, the moderator will post diabetes-related content on the WhatsApp chat group and introduce topics of interest according to a planned schedule.
This intervention takes place during Cycle 1 (first 14 weeks).
Fast-forwarding in Cycle 2Behavioural
The fast-forwarding intervention will consist of a projection of future risk of co-morbidities. A visual projection model will be built using archival data available through the Singapore Diabetes Registry. The projection model will use the current profile of the participant to calculate a risk profile for the participant's potential complications and co-morbidities, which will be presented as a pie chart. The tool will also present alternative scenarios to the participant and visualize how the likelihood of complications or co-morbidities would decrease or increases if his/her habits changed. This will provide the motivational aspect of the intervention.
This intervention takes place during Cycle 2 (second 14 weeks).
Goal-Setting plus Weekly Nudge in Cycle 2Behavioural
The procedure for goal-setting will start with the participant receiving a list of possible goals. The moderator will go through the list with the participant to identify which goals the participant is comfortable with and could reasonably achieve, and to tick off those goals that the participant has already achieved. The participants will choose their own goals. In each subsequent week, the moderator will check-in with the participant and tick off the goal(s) that have been achieved.
Chat groups of 10-15 people will be formed to administer the weekly nudge. The participants will be encouraged to introduce themselves and to interact with each other during each the chat session. Every week for the following 14 weeks, the moderator will post diabetes-related content on the WhatsApp chat group and introduce topics of interest according to a planned schedule.
This intervention takes place during Cycle 2 (second 14 weeks).
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Control condition |
| Weekly nudge in Cycle 2 | Experimental | Weekly nudge intervention in Cycle 2 Receives: Behavioral: Goal-Setting plus Weekly Nudge in Cycle 2 |
| Fast-forwarding | Experimental | Fast-forwarding interventions in both Cycles Receives: Behavioral: Fast-forwarding in Cycle 1; Behavioral: Fast-forwarding in Cycle 2 |
| Fast-forwarding with weekly nudge in Cycle 2 | Experimental | Fast-forwarding interventions in both Cycles, plus weekly nudge intervention in Cycle 2 Receives: Behavioral: Fast-forwarding in Cycle 1; Behavioral: Fast-forwarding in Cycle 2; Behavioral: Goal-Setting plus Weekly Nudge in Cycle 2 |
| Weekly nudge in Cycle 1 | Experimental | Weekly nudge intervention in Cycle 1 Receives: Behavioral: Goal-Setting plus Weekly Nudge in Cycle 1 |
| Weekly nudge | Experimental | Weekly nudge interventions in both Cycles Receives: Behavioral: Goal-Setting plus Weekly Nudge in Cycle 1; Behavioral: Goal-Setting plus Weekly Nudge in Cycle 2 |
| Fast-forwarding with weekly nudge in Cycle 1 | Experimental | Fast-forwarding interventions in both Cycles, plus weekly nudge intervention in Cycle 1 Receives: Behavioral: Fast-forwarding in Cycle 1; Behavioral: Goal-Setting plus Weekly Nudge in Cycle 1; Behavioral: Fast-forwarding in Cycle 2 |
| Full intervention | Experimental | All interventions applied in all Cycles Receives: Behavioral: Fast-forwarding in Cycle 1; Behavioral: Goal-Setting plus Weekly Nudge in Cycle 1; Behavioral: Fast-forwarding in Cycle 2; Behavioral: Goal-Setting plus Weekly Nudge in Cycle 2 |
| Fast-forwarding in Cycle 1 | Experimental | Fast-forwarding intervention in Cycle 1 Receives: Behavioral: Fast-forwarding in Cycle 1 |
| Full in Cycle 1 | Experimental | Fast-forwarding and weekly nudge interventions in Cycle 1 Receives: Behavioral: Fast-forwarding in Cycle 1; Behavioral: Goal-Setting plus Weekly Nudge in Cycle 1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c after Cycle 1
Results from HbA1c test
Measured: Measured between Weeks 17-18
HbA1c after Cycle 2
Results from HbA1c test
Measured: Measured between Weeks 33-34
Secondary outcomes (14)
Diet quality after Cycle 1
Diet quality will be measured using the well-validated Food Frequency Questionnaire
Measured: Measured between Weeks 17-18
Diet quality after Cycle 2
Diet quality will be measured using the well-validated Food Frequency Questionnaire
Measured: Measured between Weeks 33-34
Exercise levels after Cycle 1
Exercise level will be assessed based on the Global Physical Activity Questionnaire (GPAQ) developed by the World Health Organization in 2002 for chronic disease risk-factor surveillance
Measured: Measured between Weeks 17-18
Exercise levels after Cycle 2
Exercise level will be assessed based on the Global Physical Activity Questionnaire (GPAQ) developed by the World Health Organization in 2002 for chronic disease risk-factor surveillance
Measured: Measured between Weeks 33-34
Attitudes towards diabetes management after Cycle 1
The participants' psychological reactions towards diabetes treatment will be captured using three main groups of questionnaires. Their general attitudes towards diabetes will be measured using the Diabetes Attitude Survey developed and validated by the University of Michigan Diabetes Research and Training Center (MDRC). The investigators will measure how strongly the patients feel empowered to cope with and manage diabetes, which is a crucial outcome of DSME. Empowerment will be captured using the Diabetes Empowerment Scale (DES) developed by the MDRC. To gain insight into the psychological processes through which fast-forwarding and implementation influence health outcomes, the investigators will measure attitudes towards perceived barriers to diet adherence, exercise, and monitoring, using the respective subscales of the Diabetes Care Profile developed by MDTC
Measured: Measured between Weeks 17-18
Attitudes towards diabetes management after Cycle 2
The participants' psychological reactions towards diabetes treatment will be captured using three main groups of questionnaires. Their general attitudes towards diabetes will be measured using the Diabetes Attitude Survey developed and validated by the University of Michigan Diabetes Research and Training Center (MDRC). The investigators will measure how strongly the patients feel empowered to cope with and manage diabetes, which is a crucial outcome of DSME. Empowerment will be captured using the Diabetes Empowerment Scale (DES) developed by the MDRC. To gain insight into the psychological processes through which fast-forwarding and implementation influence health outcomes, the investigators will measure attitudes towards perceived barriers to diet adherence, exercise, and monitoring, using the respective subscales of the Diabetes Care Profile developed by MDTC
Measured: Measured between Weeks 33-34
Readiness for behavioral change after Cycle 1
To assess readiness for behavioural change, the investigators will ask the participants to indicate their commitment to make changes to their diet and physical activity. Specifically, the investigators will ask them to name a food that they have been told to eat less of, and to indicate how many times they are willing to cut back on the food. Similarly, the investigators will ask the participants to indicate how much time per week they are willing to exercise to avoid future complications arising from their diabetes
Measured: Measured between Weeks 17-18
Readiness for behavioral change after Cycle 2
To assess readiness for behavioural change, the investigators will ask the participants to indicate their commitment to make changes to their diet and physical activity. Specifically, the investigators will ask them to name a food that they have been told to eat less of, and to indicate how many times they are willing to cut back on the food. Similarly, the investigators will ask the participants to indicate how much time per week they are willing to exercise to avoid future complications arising from their diabetes
Measured: Measured between Weeks 33-34
Smoking status after Cycle 1
Self-reported smoking status
Measured: Measured between Weeks 17-18
Smoking status after Cycle 2
Self-reported smoking status
Measured: Measured between Weeks 33-34
Level of alcohol consumption after Cycle 1
Self-reported frequency of alcohol consumption
Measured: Measured between Weeks 17-18
Level of alcohol consumption after Cycle 2
Self-reported frequency of alcohol consumption
Measured: Measured between Weeks 33-34
Sleep quality after Cycle 1
Self-reported quality of sleep
Measured: Measured between Weeks 17-18
Sleep quality after Cycle 2
Self-reported quality of sleep
Measured: Measured between Weeks 33-34
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2022
- Study start28 Mar 2022
- Primary completion31 Aug 2023 (estimated)
- Study completion31 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- Singapore Health Services
- Responsible party
- Principal investigator, Lawrence Jin, National University of Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05203575
- Sponsor's protocol ID
- DCOF
- Status last verified
- Sep 2022
- First submitted
- 2 Dec 2021
- Last updated
- 28 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Investigators will not be storing or sharing any personal identifiers. All individual level data will be anonymized, and only anonymized data will be shared with other researchers, upon request.
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Building a Behavioural Intervention Programme to Improve Self-Management of Diabetes
- ClinicalTrials.gov ID
- NCT05203575
- Acronym / sponsor ID
- DCOF
- Conditions
- Diabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 225 participants (actual)
- Lead sponsor
- National University of SingaporeUniversity, hospital or other
- Collaborators
- Singapore Health Services
- Study start
- 28 Mar 2022 (actual)
- Primary completion
- 31 Aug 2023 (estimated)
- Study completion
- 31 Aug 2023 (estimated)
- First posted
- 24 Jan 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.
Effective control of diabetes requires patients to change their daily behaviour. The investigators propose an intervention programme for behavioural change with two components, targeting motivation and implementation. The motivation component raises the salience of probable patient-specific detrimental future outcomes by 'fast-forwarding' awareness of these outcomes to the present. The implementation component helps patients to set goals and to act based on weekly tips. A factorial design will be used to establish the necessity and sufficiency of the two components on changing mind and guiding behaviour to improve blood glucose level. Individual-level measures of psychological, physical and medical conditions will be shown to drive the heterogenous responses to the two components. Intervention is expanded into two cycles with crossover design to demonstrate how the individual-level measures drive the wear-off, built-up and persistence of the two components. The results of this two-component programme will serve as a basis for systematic synthesis of component-level effectiveness in behavioural intervention research.
Detailed description
This behavioural-change-intervention programme will be an online 'single-centre' outpatient randomized controlled trial (RCT) with ten study arms. It will be a two-component intervention consisting of a motivation component of fast-forwarding and an implementation component of goal-setting and weekly nudges. The field intervention will be structured into a two-cycle four-treatment crossover design with four treatment conditions in the first cycle and crossing-over into eight treatment conditions (including one control condition) in the second cycle. In addition to the control group in the study, a group of patients from the Singapore Health Services (SingHealth) Diabetes Registry dataset will be identified using propensity scoring to serve as a 'match-pair' for each study participant. The electronic medical record of this match-pair will provide an additional benchmark of biological measure in addition to that provided by the control group.
The field study will run for 34 weeks, in two cycles of 14 weeks each, with a 2-week transition period between the two cycles. There will also be a 2-week baseline period in which baseline measurements will be taken before the first cycle begins and a 2-week debriefing period where the final measurement will be taken after the end of the second cycle. Measurements will be taken three times: once before Cycle 1 (as the baseline), once between Cycles 1 and 2, and once at the end of Cycle 2. Participants who are assigned to the motivation component of fast-forwarding will receive fast-forwarding immediately after the measurement session and before the cycle. The participants who are randomly assigned to treatment conditions, including the implementation component, will receive a weekly nudge programme with each 14-week cycle. All participants will have access to the resources used to generate the 14-week cycles.
The investigators will measure the following: (i) physiological and medical information related to the progression of diabetes; (ii) diet quality and exercise level; (iii) psychological reactions towards diabetes management; (iv) behavioural change readiness and commitment; and (v) lifestyle (smoking, alcohol consumption, and sleep quality).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Control condition |
| Weekly nudge in Cycle 2 | Experimental | Behavioral: Goal-Setting plus Weekly Nudge in Cycle 2Weekly nudge intervention in Cycle 2 |
| Fast-forwarding | Experimental | Behavioral: Fast-forwarding in Cycle 1, Behavioral: Fast-forwarding in Cycle 2Fast-forwarding interventions in both Cycles |
| Fast-forwarding with weekly nudge in Cycle 2 | Experimental | Behavioral: Fast-forwarding in Cycle 1, Behavioral: Fast-forwarding in Cycle 2, Behavioral: Goal-Setting plus Weekly Nudge in Cycle 2Fast-forwarding interventions in both Cycles, plus weekly nudge intervention in Cycle 2 |
| Weekly nudge in Cycle 1 | Experimental | Behavioral: Goal-Setting plus Weekly Nudge in Cycle 1Weekly nudge intervention in Cycle 1 |
| Weekly nudge | Experimental | Behavioral: Goal-Setting plus Weekly Nudge in Cycle 1, Behavioral: Goal-Setting plus Weekly Nudge in Cycle 2Weekly nudge interventions in both Cycles |
| Fast-forwarding with weekly nudge in Cycle 1 | Experimental | Behavioral: Fast-forwarding in Cycle 1, Behavioral: Goal-Setting plus Weekly Nudge in Cycle 1, Behavioral: Fast-forwarding in Cycle 2Fast-forwarding interventions in both Cycles, plus weekly nudge intervention in Cycle 1 |
| Full intervention | Experimental | Behavioral: Fast-forwarding in Cycle 1, Behavioral: Goal-Setting plus Weekly Nudge in Cycle 1, Behavioral: Fast-forwarding in Cycle 2, Behavioral: Goal-Setting plus Weekly Nudge in Cycle 2All interventions applied in all Cycles |
| Fast-forwarding in Cycle 1 | Experimental | Behavioral: Fast-forwarding in Cycle 1Fast-forwarding intervention in Cycle 1 |
| Full in Cycle 1 | Experimental | Behavioral: Fast-forwarding in Cycle 1, Behavioral: Goal-Setting plus Weekly Nudge in Cycle 1Fast-forwarding and weekly nudge interventions in Cycle 1 |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age between 21-70
- Has type 2 diabetes
- Comfortable communicating English
- Uses smartphone app WhatsApp
Key exclusion criteria (2 listed)
- Participants with diagnoses of mental health illnesses
- Participants who are unable to provide informed consent
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 |
|---|---|---|
| Fast-forwarding in Cycle 1The fast-forwarding intervention will consist of a projection of future risk of co-morbidities. A visual projection model will be built using archival data available through the Singapore Diabetes Registry. The projection model will use the current profile of the participant to calculate a risk profile for the participant's potential complications and co-morbidities, which will be presented as a pie chart. The tool will also present alternative scenarios to the participant and visualize how the likelihood of complications or co-morbidities would decrease or increases if his/her habits changed. This will provide the motivational aspect of the intervention. This intervention takes place during Cycle 1 (first 14 weeks). | Behavioural | Fast-forwarding, Fast-forwarding in Cycle 1, Fast-forwarding with weekly nudge in Cycle 1, Fast-forwarding with weekly nudge in Cycle 2, Full in Cycle 1, Full intervention |
| Goal-Setting plus Weekly Nudge in Cycle 1The procedure for goal-setting will start with the participant receiving a list of possible goals. The moderator will go through the list with the participant to identify which goals the participant is comfortable with and could reasonably achieve, and to tick off those goals that the participant has already achieved. The participants will choose their own goals. In each subsequent week, the moderator will check-in with the participant and tick off the goal(s) that have been achieved. Chat groups of 10-15 people will be formed to administer the weekly nudge. The participants will be encouraged to introduce themselves and to interact with each other during each the chat session. Every week for the following 14 weeks, the moderator will post diabetes-related content on the WhatsApp chat group and introduce topics of interest according to a planned schedule. This intervention takes place during Cycle 1 (first 14 weeks). | Behavioural | Fast-forwarding with weekly nudge in Cycle 1, Full in Cycle 1, Full intervention, Weekly nudge, Weekly nudge in Cycle 1 |
| Fast-forwarding in Cycle 2The fast-forwarding intervention will consist of a projection of future risk of co-morbidities. A visual projection model will be built using archival data available through the Singapore Diabetes Registry. The projection model will use the current profile of the participant to calculate a risk profile for the participant's potential complications and co-morbidities, which will be presented as a pie chart. The tool will also present alternative scenarios to the participant and visualize how the likelihood of complications or co-morbidities would decrease or increases if his/her habits changed. This will provide the motivational aspect of the intervention. This intervention takes place during Cycle 2 (second 14 weeks). | Behavioural | Fast-forwarding, Fast-forwarding with weekly nudge in Cycle 1, Fast-forwarding with weekly nudge in Cycle 2, Full intervention |
| Goal-Setting plus Weekly Nudge in Cycle 2The procedure for goal-setting will start with the participant receiving a list of possible goals. The moderator will go through the list with the participant to identify which goals the participant is comfortable with and could reasonably achieve, and to tick off those goals that the participant has already achieved. The participants will choose their own goals. In each subsequent week, the moderator will check-in with the participant and tick off the goal(s) that have been achieved. Chat groups of 10-15 people will be formed to administer the weekly nudge. The participants will be encouraged to introduce themselves and to interact with each other during each the chat session. Every week for the following 14 weeks, the moderator will post diabetes-related content on the WhatsApp chat group and introduce topics of interest according to a planned schedule. This intervention takes place during Cycle 2 (second 14 weeks). | Behavioural | Fast-forwarding with weekly nudge in Cycle 2, Full intervention, Weekly nudge, Weekly nudge in Cycle 2 |
Primary outcome
HbA1c after Cycle 1
Time frame: Measured between Weeks 17-18
Results from HbA1c test
HbA1c after Cycle 2
Time frame: Measured between Weeks 33-34
Results from HbA1c test
14 secondary outcomes
Diet quality after Cycle 1
Time frame: Measured between Weeks 17-18
Diet quality after Cycle 2
Time frame: Measured between Weeks 33-34
Exercise levels after Cycle 1
Time frame: Measured between Weeks 17-18
Exercise levels after Cycle 2
Time frame: Measured between Weeks 33-34
Attitudes towards diabetes management after Cycle 1
Time frame: Measured between Weeks 17-18
Attitudes towards diabetes management after Cycle 2
Time frame: Measured between Weeks 33-34
Readiness for behavioral change after Cycle 1
Time frame: Measured between Weeks 17-18
Readiness for behavioral change after Cycle 2
Time frame: Measured between Weeks 33-34
Smoking status after Cycle 1
Time frame: Measured between Weeks 17-18
Smoking status after Cycle 2
Time frame: Measured between Weeks 33-34
Level of alcohol consumption after Cycle 1
Time frame: Measured between Weeks 17-18
Level of alcohol consumption after Cycle 2
Time frame: Measured between Weeks 33-34
Sleep quality after Cycle 1
Time frame: Measured between Weeks 17-18
Sleep quality after Cycle 2
Time frame: Measured between Weeks 33-34
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2022.
- Individual participant dataSharing planned: Yes. Investigators will not be storing or sharing any personal identifiers. All individual level data will be anonymized, and only anonymized data will be shared with other researchers, upon request.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fast-forwarding in Cycle 1, Goal-Setting plus Weekly Nudge in Cycle 1 and Fast-forwarding in Cycle 2 in people with Diabetes, run by National University of Singapore at 1 site in Singapore.
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 2 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 28 Sep 2022. 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 Singapore. 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?
Results are not available in the source record.
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?
HbA1c after Cycle 1 (time frame: Measured between Weeks 17-18). 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?
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 28 Sep 2022.