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Building a Behavioural Intervention Programme to Improve Self-Management of Diabetes

Primary Purpose

Diabetes

Status
Active
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
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
Sponsored by
National University of Singapore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Diabetes

Eligibility Criteria

21 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age between 21-70
  • Has type 2 diabetes
  • Comfortable communicating English
  • Uses smartphone app WhatsApp

Exclusion Criteria:

  • Participants with diagnoses of mental health illnesses
  • Participants who are unable to provide informed consent

Sites / Locations

  • National University of Singapore

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm Type

No Intervention

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Control

Weekly nudge in Cycle 2

Fast-forwarding

Fast-forwarding with weekly nudge in Cycle 2

Weekly nudge in Cycle 1

Weekly nudge

Fast-forwarding with weekly nudge in Cycle 1

Full intervention

Fast-forwarding in Cycle 1

Full in Cycle 1

Arm Description

Control condition

Weekly nudge intervention in Cycle 2

Fast-forwarding interventions in both Cycles

Fast-forwarding interventions in both Cycles, plus weekly nudge intervention in Cycle 2

Weekly nudge intervention in Cycle 1

Weekly nudge interventions in both Cycles

Fast-forwarding interventions in both Cycles, plus weekly nudge intervention in Cycle 1

All interventions applied in all Cycles

Fast-forwarding intervention in Cycle 1

Fast-forwarding and weekly nudge interventions in Cycle 1

Outcomes

Primary Outcome Measures

HbA1c after Cycle 1
Results from HbA1c test
HbA1c after Cycle 2
Results from HbA1c test

Secondary Outcome Measures

Diet quality after Cycle 1
Diet quality will be measured using the well-validated Food Frequency Questionnaire
Diet quality after Cycle 2
Diet quality will be measured using the well-validated Food Frequency Questionnaire
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
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
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
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
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
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
Smoking status after Cycle 1
Self-reported smoking status
Smoking status after Cycle 2
Self-reported smoking status
Level of alcohol consumption after Cycle 1
Self-reported frequency of alcohol consumption
Level of alcohol consumption after Cycle 2
Self-reported frequency of alcohol consumption
Sleep quality after Cycle 1
Self-reported quality of sleep
Sleep quality after Cycle 2
Self-reported quality of sleep

Full Information

First Posted
December 2, 2021
Last Updated
September 27, 2022
Sponsor
National University of Singapore
Collaborators
Singapore Health Services
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1. Study Identification

Unique Protocol Identification Number
NCT05203575
Brief Title
Building a Behavioural Intervention Programme to Improve Self-Management of Diabetes
Official Title
Building a Behavioural Intervention Programme to Improve Self-Management of Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 28, 2022 (Actual)
Primary Completion Date
August 31, 2023 (Anticipated)
Study Completion Date
August 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National University of Singapore
Collaborators
Singapore Health Services

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
225 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Control condition
Arm Title
Weekly nudge in Cycle 2
Arm Type
Experimental
Arm Description
Weekly nudge intervention in Cycle 2
Arm Title
Fast-forwarding
Arm Type
Experimental
Arm Description
Fast-forwarding interventions in both Cycles
Arm Title
Fast-forwarding with weekly nudge in Cycle 2
Arm Type
Experimental
Arm Description
Fast-forwarding interventions in both Cycles, plus weekly nudge intervention in Cycle 2
Arm Title
Weekly nudge in Cycle 1
Arm Type
Experimental
Arm Description
Weekly nudge intervention in Cycle 1
Arm Title
Weekly nudge
Arm Type
Experimental
Arm Description
Weekly nudge interventions in both Cycles
Arm Title
Fast-forwarding with weekly nudge in Cycle 1
Arm Type
Experimental
Arm Description
Fast-forwarding interventions in both Cycles, plus weekly nudge intervention in Cycle 1
Arm Title
Full intervention
Arm Type
Experimental
Arm Description
All interventions applied in all Cycles
Arm Title
Fast-forwarding in Cycle 1
Arm Type
Experimental
Arm Description
Fast-forwarding intervention in Cycle 1
Arm Title
Full in Cycle 1
Arm Type
Experimental
Arm Description
Fast-forwarding and weekly nudge interventions in Cycle 1
Intervention Type
Behavioral
Intervention Name(s)
Fast-forwarding in Cycle 1
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Goal-Setting plus Weekly Nudge in Cycle 1
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Fast-forwarding in Cycle 2
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Goal-Setting plus Weekly Nudge in Cycle 2
Intervention Description
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).
Primary Outcome Measure Information:
Title
HbA1c after Cycle 1
Description
Results from HbA1c test
Time Frame
Measured between Weeks 17-18
Title
HbA1c after Cycle 2
Description
Results from HbA1c test
Time Frame
Measured between Weeks 33-34
Secondary Outcome Measure Information:
Title
Diet quality after Cycle 1
Description
Diet quality will be measured using the well-validated Food Frequency Questionnaire
Time Frame
Measured between Weeks 17-18
Title
Diet quality after Cycle 2
Description
Diet quality will be measured using the well-validated Food Frequency Questionnaire
Time Frame
Measured between Weeks 33-34
Title
Exercise levels after Cycle 1
Description
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
Time Frame
Measured between Weeks 17-18
Title
Exercise levels after Cycle 2
Description
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
Time Frame
Measured between Weeks 33-34
Title
Attitudes towards diabetes management after Cycle 1
Description
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
Time Frame
Measured between Weeks 17-18
Title
Attitudes towards diabetes management after Cycle 2
Description
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
Time Frame
Measured between Weeks 33-34
Title
Readiness for behavioral change after Cycle 1
Description
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
Time Frame
Measured between Weeks 17-18
Title
Readiness for behavioral change after Cycle 2
Description
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
Time Frame
Measured between Weeks 33-34
Title
Smoking status after Cycle 1
Description
Self-reported smoking status
Time Frame
Measured between Weeks 17-18
Title
Smoking status after Cycle 2
Description
Self-reported smoking status
Time Frame
Measured between Weeks 33-34
Title
Level of alcohol consumption after Cycle 1
Description
Self-reported frequency of alcohol consumption
Time Frame
Measured between Weeks 17-18
Title
Level of alcohol consumption after Cycle 2
Description
Self-reported frequency of alcohol consumption
Time Frame
Measured between Weeks 33-34
Title
Sleep quality after Cycle 1
Description
Self-reported quality of sleep
Time Frame
Measured between Weeks 17-18
Title
Sleep quality after Cycle 2
Description
Self-reported quality of sleep
Time Frame
Measured between Weeks 33-34

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age between 21-70 Has type 2 diabetes Comfortable communicating English Uses smartphone app WhatsApp Exclusion Criteria: Participants with diagnoses of mental health illnesses Participants who are unable to provide informed consent
Facility Information:
Facility Name
National University of Singapore
City
Singapore
Country
Singapore

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
The supporting information will be made available upon publication in the supporting documentation.
IPD Sharing Access Criteria
It will be made available in the supporting documentation.

Learn more about this trial

Building a Behavioural Intervention Programme to Improve Self-Management of Diabetes

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