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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Diabetes
• Intervention / Treatment: Behavioral: Goal-Setting plus Weekly Nudge in Cycle 2; Behavioral: Fast-forwarding in Cycle 1; Behavioral: Fast-forwarding in Cycle 2; Behavioral: Goal-Setting plus Weekly Nudge in Cycle 1

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 Type: Interventional
• Enrollment (Actual): 225
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore
    • National University of Singapore

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

10

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Control condition
Experimental: Weekly nudge in Cycle 2; Weekly nudge intervention in Cycle 2	Behavioral: Goal-Setting plus Weekly Nudge in Cycle 2; 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).
Experimental: Fast-forwarding; Fast-forwarding interventions in both Cycles	Behavioral: Fast-forwarding in Cycle 1; 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).; Behavioral: Fast-forwarding in Cycle 2; 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).
Experimental: Fast-forwarding with weekly nudge in Cycle 2; Fast-forwarding interventions in both Cycles, plus weekly nudge intervention in Cycle 2	Behavioral: Goal-Setting plus Weekly Nudge in Cycle 2; 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).; Behavioral: Fast-forwarding in Cycle 1; 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).; Behavioral: Fast-forwarding in Cycle 2; 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).
Experimental: Weekly nudge in Cycle 1; Weekly nudge intervention in Cycle 1	Behavioral: Goal-Setting plus Weekly Nudge in Cycle 1; 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).
Experimental: Weekly nudge; Weekly nudge interventions in both Cycles	Behavioral: Goal-Setting plus Weekly Nudge in Cycle 2; 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).; Behavioral: Goal-Setting plus Weekly Nudge in Cycle 1; 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).
Experimental: Fast-forwarding with weekly nudge in Cycle 1; Fast-forwarding interventions in both Cycles, plus weekly nudge intervention in Cycle 1	Behavioral: Fast-forwarding in Cycle 1; 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).; Behavioral: Fast-forwarding in Cycle 2; 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).; Behavioral: Goal-Setting plus Weekly Nudge in Cycle 1; 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).
Experimental: Full intervention; All interventions applied in all Cycles	Behavioral: Goal-Setting plus Weekly Nudge in Cycle 2; 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).; Behavioral: Fast-forwarding in Cycle 1; 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).; Behavioral: Fast-forwarding in Cycle 2; 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).; Behavioral: Goal-Setting plus Weekly Nudge in Cycle 1; 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).
Experimental: Fast-forwarding in Cycle 1; Fast-forwarding intervention in Cycle 1	Behavioral: Fast-forwarding in Cycle 1; 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).
Experimental: Full in Cycle 1; Fast-forwarding and weekly nudge interventions in Cycle 1	Behavioral: Fast-forwarding in Cycle 1; 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).; Behavioral: Goal-Setting plus Weekly Nudge in Cycle 1; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diet quality after Cycle 1	Diet quality will be measured using the well-validated Food Frequency Questionnaire	Measured between Weeks 17-18
Diet quality after Cycle 2	Diet quality will be measured using the well-validated Food Frequency Questionnaire	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 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 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 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 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 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 between Weeks 33-34
Smoking status after Cycle 1	Self-reported smoking status	Measured between Weeks 17-18
Smoking status after Cycle 2	Self-reported smoking status	Measured between Weeks 33-34
Level of alcohol consumption after Cycle 1	Self-reported frequency of alcohol consumption	Measured between Weeks 17-18
Level of alcohol consumption after Cycle 2	Self-reported frequency of alcohol consumption	Measured between Weeks 33-34
Sleep quality after Cycle 1	Self-reported quality of sleep	Measured between Weeks 17-18
Sleep quality after Cycle 2	Self-reported quality of sleep	Measured between Weeks 33-34

Collaborators and Investigators

• Sponsor: National University of Singapore
• Collaborators: Singapore Health Services

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2022
• Primary Completion (Anticipated): August 31, 2023
• Study Completion (Anticipated): August 31, 2023

Study Registration Dates

• First Submitted: December 2, 2021
• First Submitted That Met QC Criteria: January 15, 2022
• First Posted (Actual): January 24, 2022

Study Record Updates

• Last Update Posted (Actual): September 28, 2022
• Last Update Submitted That Met QC Criteria: September 27, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: DCOF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No