Clinical trial NCT05203575: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes
Lead sponsor: National University of Singapore
Sponsor class: OTHER
Collaborators: name: Singapore Health Services
First posted: 2022-01-24
Enrollment: 225
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: OTHER

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).

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

Primary outcomes:
measure: HbA1c after Cycle 1
timeFrame: Measured between Weeks 17-18
measure: HbA1c after Cycle 2
timeFrame: Measured between Weeks 33-34
Secondary outcomes:
measure: Diet quality after Cycle 1
timeFrame: Measured between Weeks 17-18
measure: Diet quality after Cycle 2
timeFrame: Measured between Weeks 33-34
measure: Exercise levels after Cycle 1
timeFrame: Measured between Weeks 17-18
measure: Exercise levels after Cycle 2
timeFrame: Measured between Weeks 33-34
measure: Attitudes towards diabetes management after Cycle 1
timeFrame: Measured between Weeks 17-18
measure: Attitudes towards diabetes management after Cycle 2
timeFrame: Measured between Weeks 33-34
measure: Readiness for behavioral change after Cycle 1
timeFrame: Measured between Weeks 17-18
measure: Readiness for behavioral change after Cycle 2
timeFrame: Measured between Weeks 33-34
measure: Smoking status after Cycle 1
timeFrame: Measured between Weeks 17-18
measure: Smoking status after Cycle 2
timeFrame: Measured between Weeks 33-34
measure: Level of alcohol consumption after Cycle 1
timeFrame: Measured between Weeks 17-18
measure: Level of alcohol consumption after Cycle 2
timeFrame: Measured between Weeks 33-34
measure: Sleep quality after Cycle 1
timeFrame: Measured between Weeks 17-18
measure: Sleep quality after Cycle 2
timeFrame: Measured between Weeks 33-34
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University of Singapore
Study officials:
References: