Clinical Trials Logo

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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT05203575
Study type Interventional
Source National University, Singapore
Contact
Status Active, not recruiting
Phase N/A
Start date March 28, 2022
Completion date August 31, 2023

See also
  Status Clinical Trial Phase
Recruiting NCT03975309 - DHS MIND Metabolomics
Completed NCT01855399 - Technologically Enhanced Coaching: A Program to Improve Diabetes Outcomes N/A
Completed NCT01819129 - Efficacy and Safety of FIAsp Compared to Insulin Aspart in Combination With Insulin Glargine and Metformin in Adults With Type 2 Diabetes Phase 3
Recruiting NCT05007990 - Caregiving Networks Across Disease Context and the Life Course
Recruiting NCT04420936 - Pragmatic Research in Healthcare Settings to Improve Diabetes and Obesity Prevention and Care for Our Program N/A
Recruiting NCT03549559 - Imaging Histone Deacetylase in the Heart N/A
Completed NCT04903496 - Clinical Characteristics and Disease Burden of Diabetic Patients Based on Tianjin Regional Database
Completed NCT01437592 - Investigating the Pharmacokinetic Properties of NN1250 in Healthy Chinese Subjects Phase 1
Completed NCT01696266 - An International Survey on Hypoglycaemia Among Insulin-treated Patients With Diabetes
Completed NCT04082585 - Total Health Improvement Program Research Project
Completed NCT03390179 - Hyperglycemic Response and Steroid Administration After Surgery (DexGlySurgery)
Not yet recruiting NCT04887688 - Exciflex for Chronic Wound Therapy N/A
Not yet recruiting NCT05029804 - Effect of Walking Exercise Training on Adherence to Disease Management and Metabolic Control in Diabetes N/A
Recruiting NCT05294822 - Autologous Regenerative Islet Transplantation for Insulin-dependent Diabetes N/A
Completed NCT04427982 - Dance and Diabetes/Prediabetes Self-Management N/A
Completed NCT02356848 - STEP UP to Avert Amputation in Diabetes N/A
Completed NCT03292185 - A Trial to Investigate the Single Dose Pharmacokinetics of Insulin Degludec/Liraglutide Compared With Insulin Degludec and Liraglutide in Healthy Chinese Subjects Phase 1
Recruiting NCT04496401 - PK Study in Diabetic Transplant récipients : From Twice-daily Tacrolimus to Once-daily Extended-release Tacrolimus Phase 4
Recruiting NCT04452331 - Assessing Open Access Audio N/A
Recruiting NCT05477368 - Examining the Feasibility of Prolonged Ketone Supplement Drink Consumption in Adults With Type 2 Diabetes N/A