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

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05203575
• Other study ID #: DCOF
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 28, 2022
• Est. completion date: August 31, 2023

Study information

• Verified date: September 2022
• Source: National University, Singapore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 225
• Est. completion date: August 31, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus

Intervention

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).
• 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).
• 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).
• 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).

Locations

Country	Name	City	State
Singapore	National University of Singapore	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
National University, Singapore	Singapore Health Services

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c after Cycle 1	Results from HbA1c test	Measured between Weeks 17-18
Primary	HbA1c after Cycle 2	Results from HbA1c test	Measured between Weeks 33-34
Secondary	Diet quality after Cycle 1	Diet quality will be measured using the well-validated Food Frequency Questionnaire	Measured between Weeks 17-18
Secondary	Diet quality after Cycle 2	Diet quality will be measured using the well-validated Food Frequency Questionnaire	Measured between Weeks 33-34
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Smoking status after Cycle 1	Self-reported smoking status	Measured between Weeks 17-18
Secondary	Smoking status after Cycle 2	Self-reported smoking status	Measured between Weeks 33-34
Secondary	Level of alcohol consumption after Cycle 1	Self-reported frequency of alcohol consumption	Measured between Weeks 17-18
Secondary	Level of alcohol consumption after Cycle 2	Self-reported frequency of alcohol consumption	Measured between Weeks 33-34
Secondary	Sleep quality after Cycle 1	Self-reported quality of sleep	Measured between Weeks 17-18
Secondary	Sleep quality after Cycle 2	Self-reported quality of sleep	Measured between Weeks 33-34