Building a Behavioural Intervention Programme to Improve Self-Management of Diabetes
1 other identifier
interventional
225
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable diabetes
Started Mar 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 2, 2021
CompletedFirst Posted
Study publicly available on registry
January 24, 2022
CompletedStudy Start
First participant enrolled
March 28, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2023
CompletedSeptember 28, 2022
September 1, 2022
1.4 years
December 2, 2021
September 27, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
HbA1c after Cycle 1
Results from HbA1c test
Measured between Weeks 17-18
HbA1c after Cycle 2
Results from HbA1c test
Measured between Weeks 33-34
Secondary Outcomes (14)
Diet quality after Cycle 1
Measured between Weeks 17-18
Diet quality after Cycle 2
Measured between Weeks 33-34
Exercise levels after Cycle 1
Measured between Weeks 17-18
Exercise levels after Cycle 2
Measured between Weeks 33-34
Attitudes towards diabetes management after Cycle 1
Measured between Weeks 17-18
- +9 more secondary outcomes
Study Arms (10)
Control
NO INTERVENTIONControl condition
Weekly nudge in Cycle 2
EXPERIMENTALWeekly nudge intervention in Cycle 2
Fast-forwarding
EXPERIMENTALFast-forwarding interventions in both Cycles
Fast-forwarding with weekly nudge in Cycle 2
EXPERIMENTALFast-forwarding interventions in both Cycles, plus weekly nudge intervention in Cycle 2
Weekly nudge in Cycle 1
EXPERIMENTALWeekly nudge intervention in Cycle 1
Weekly nudge
EXPERIMENTALWeekly nudge interventions in both Cycles
Fast-forwarding with weekly nudge in Cycle 1
EXPERIMENTALFast-forwarding interventions in both Cycles, plus weekly nudge intervention in Cycle 1
Full intervention
EXPERIMENTALAll interventions applied in all Cycles
Fast-forwarding in Cycle 1
EXPERIMENTALFast-forwarding intervention in Cycle 1
Full in Cycle 1
EXPERIMENTALFast-forwarding and weekly nudge interventions in Cycle 1
Interventions
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).
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).
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).
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).
Eligibility Criteria
You may qualify if:
- Age between 21-70
- Has type 2 diabetes
- Comfortable communicating English
- Uses smartphone app WhatsApp
You may not qualify if:
- Participants with diagnoses of mental health illnesses
- Participants who are unable to provide informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National University of Singaporelead
- Singapore Health Servicescollaborator
Study Sites (1)
National University of Singapore
Singapore, Singapore
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
December 2, 2021
First Posted
January 24, 2022
Study Start
March 28, 2022
Primary Completion
August 31, 2023
Study Completion
August 31, 2023
Last Updated
September 28, 2022
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ANALYTIC CODE
- Time Frame
- The supporting information will be made available upon publication in the supporting documentation.
- Access Criteria
- It will be made available in the supporting documentation.
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.