Interactive virtual assistance for mental health promotion and self-care management in elderly with type 2 diabetes (IVAM-ED): study protocol and statistical analysis plan for a randomized controlled trial.

BACKGROUND: With one in five individuals aged 65 or older living with type 2 diabetes worldwide, it is crucial to acknowledge and address the challenges faced by this population. In this context, our study aims to evaluate the efficacy of a behavioral intervention model delivered through a smart speaker on mental health and diabetes self-care in the elderly with diabetes. METHODS: This is a single-center, pragmatic, parallel two-arm open randomized clinical trial involving elderly patients with type 2 diabetes. We plan to enroll a total of 112 individuals who will be randomized 1:1 to receive the Smart Speaker EchoDot 3rd Gen device (Amazon Echo®) for home use (intervention arm) or to maintain usual care (control arm). The primary outcome is mental distress, assessed using the 20-item Self Reporting Questionnaire (SRQ-20) after a 12-week intervention period. Secondary outcomes include quality of life, adherence to diabetes self-care behaviors, perception of stress, glycemic control, blood pressure, and lipid profile. Analysis of covariance (ANCOVA) will be used to evaluate the effects of the intervention on the outcomes. DISCUSSION: This study assesses the effectiveness of an interactive virtual assistance system for enhancing mental health and glycemic control among elderly individuals with type 2 diabetes. The findings may introduce smart speakers as a valuable tool for promoting diabetes-related self-care in this population. TRIAL REGISTRATION: ClinicalTrials.gov NCT05329376. Registered on 15 April 2022. Enrollment began on 20 June 2023 and the last update of protocol was on 13 December 2023.

Obesity bias: How can this underestimated problem affect medical decisions in healthcare? A systematic review.

INTRODUCTION: Obesity is often labeled as a physical characteristic of a patient rather than a disease and it is subject to obesity bias by health providers, which harms the equality of healthcare in this population. OBJECTIVE: Identifying whether obesity bias interferes in clinical decision-making in the treatment of patients with obesity. METHODS: A systematic review of observational studies published between 1993 and 2023 in MEDLINE, Embase, and Cochrane Library on obesity bias and therapeutic decisions was carried out. The last search was conducted on June 30, 2023. The main outcome was the difference between clinical decisions in the treatment of individuals with and without obesity. The Newcastle-Ottawa scale for observational studies was used to assess for quality. After the selection process, articles were presented in narrative and thematic synthesis categories to better organize the descriptive analysis. RESULTS: Of the 2546 records identified, 13 were included. The findings showed fewer screening exams for cancer in patients with obesity, who were also susceptible to less frequent pharmacological treatment intensification in the management of diabetes. Women with obesity received fewer pelvic exams and evidence of diminished visual contact and physician confidence in treatment adherence was reported. Some studies found no disparities in treatment for abdominal pain and tension headaches between patients presented with and without obesity. CONCLUSION: The presence of obesity bias has negative effects on medical decision-making and on the quality of care provided to patients with obesity. These findings reveal the urgent necessity for reflection and development of strategies to mitigate its adverse impacts. (The protocol was registered with the international prospective register of systematic reviews, PROSPERO, under the number CRD42022307567).