RESUMO
BACKGROUND: Type 2 diabetes (T2D), a major risk factor for cardiovascular disease and other adverse health conditions, is on the rise in Singapore. TRIPOD is a randomized controlled trial aimed to determine whether complementing usual care with an evidence-based diabetes management package (DMP) -comprising access to an evidence-based app, health coaching, pedometer, glucometer and weighing scale, with or without a financial rewards scheme (M-POWER rewards), can improve mean HbA1c levels at months 6 and 12. METHODS: The protocol was published in Trials, accessible via https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-019-3749-x 1. This manuscript updates the protocol with changes to the study design due to challenges with recruitment and presents baseline characteristics. Key updates include changing the arm allocation ratio from 1:1:1 (Arm 1-Usual Care: Arm 2-DMP: Arm 3-DMP+M-POWER rewards) to 10:1:10, the sample size from 339 to 269, the intervention period from two to one year, and the primary hypothesis to focus solely on differences between Usual Care and DMP+M-POWER rewards. Recruitment for the study began on 19 October 2019 and ended on 4 June 2022. RESULTS: The average age of participants was 55.0 (SD9.7) years old and 64.2% were male. The majority of participants (76.8%) were Chinese, 4.9% Malay and 18.3% Indian and of other ethnicities. 67.0% had a monthly household income of SGD$4000 or more. The mean baseline HbA1c was 8.10% (SD 0.95) and the mean body mass index was 26.8 kg/m2 (SD 5.3). DISCUSSION: The final participant completed month 12 follow-up data collection on 8 June 2023. All pre-planned analyses will be conducted and final results reported. TRIAL REGISTRATION: ClinicalTrials.gov NCT03800680 . Registered on 11 January 2019.
Assuntos
Doenças Cardiovasculares , Diabetes Mellitus Tipo 2 , Humanos , Masculino , Criança , Feminino , Diabetes Mellitus Tipo 2/diagnóstico , Diabetes Mellitus Tipo 2/terapia , Projetos de Pesquisa , Tamanho da Amostra , Fatores de Risco , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
The retinal projection to the superior colliculus is thought to be important both for stimulus-driven eye movements and for the involuntary capture of attention. It has further been argued that eye-movement planning and attentional orienting share common neural mechanisms. Electrophysiological studies have shown that the superior colliculus receives no direct projections from short-wave-sensitive cones (S cones), and, consistent with this, we found that irrelevant peripheral stimuli visible only to S cones did not produce the saccadic distractor effect produced by luminance stimuli. However, when involuntary orienting was tested in a Posner cueing task, the same S-cone stimuli had normal attentional effects, in that they accelerated or delayed responses to subsequent targets. We conclude that involuntary attentional shifts do not require signals in the direct collicular pathway, or indeed the magnocellular pathway, as our S-cone stimuli were invisible to this channel also.