Authors
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Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da USP -More
Category
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Primary study
Registry of Trials»Brazilian Registry of Clinical Trials
Year
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2026
INTERVENTION: Randomized controlled clinical trial with two arms and a blinded assessor. Participants will be randomized in a one to one ratio. The Structured Face to Face Educational Intervention Group (Intervention Group) will include forty four participants or the Printed Educational Intervention Group (Control Group) will include forty four participants. Both groups will receive an educational booklet containing information on physical activity, sedentary behavior, healthy eating, sleep hygiene, well‐being, social participation and fall prevention. The Structured Face to Face Educational Intervention Group will additionally participate in three face to face sessions during which previously recorded video lectures addressing health literacy, communication, healthy lifestyle habits and fall prevention with a focus on environmental hazards in the home will be presented. Outcomes will be assessed at the beginning of the study and thirty days after the intervention. The assessor will remain blinded to the participants' group allocation CONDITION: Accidental Falls ; Health of the Elderly SP2.770.750.653 PRIMARY OUTCOME: It’s expected to observe the effect of the educational intervention on the environmental risk of falls, the outcome will be verified using the Home Falls and Accidents Screening Tool, changes in the instrument's total score between the baseline assessment and the reassessment after thirty days will be analyzed, comparing the groups with the structured in‐person educational intervention and the printed educational intervention INCLUSION CRITERIA: Being 50 years of age or older; independent ambulation; ability to understand and respond to the assessment instruments; and agreeing to participate in the study by signing the Informed Consent Form (ICF) SECONDARY OUTCOME: It’s expected to observe the effect of the educational intervention on body composition, the outcome will be verified using bioelectrical impedance analysis, changes in lean mass, fat mass, visceral fat, and phase angle parameters will be analyzed between baseline assessment and reassessment after thirty days It’s expected to observe the effect of the educational intervention on health literacy, the outcome will be verified using the European Health Literacy Questionnaire Brazilian reduced version, changes in the total score and health literacy classification between the baseline assessment and the reassessment after thirty days will be analyzed It’s expected to observe the effect of the educational intervention on nutritional status, the outcome will be verified using the Mini Nutritional Assessment, changes in classification and total score between the baseline assessment and the reassessment after thirty days will be analyzed It’s expected to observe the effect of the educational intervention on overall self‐efficacy, the outcome will be verified using the General Self‐Efficacy Scale, changes in the total score between the baseline assessment and the reassessment after thirty days will be analyzed It’s expected to observe the effect of the educational intervention on sedentary behavior, the outcome will be verified using the Longitudinal Aging Study Amsterdam, Sedentary Behavior Questionnaire and the accelerometer, changes in sedentary time between the baseline assessment and the reassessment after thirty days will be analyzed It’s expected to observe the effect of the educational intervention on sleep quality and related symptoms, the outcome will be verified using the Pittsburgh Sleep Quality Index, the Epworth Sleepiness Scale, the Insomnia Severity Index, and the Federal University of Minas Gerais Sleep Complaints Questionnaire, changes in instrument scores between baseline assessment and reassessment after thirty days will be analyzed It’s expected to observe the effect of the educational intervention on the level of physical activity, the outcome will be verified using the Incidental and Planned Exercise Questionnaire Walking and the accelerometer, changes in physical activity levels between baseline assessment and reassessment after thirty days will be analyzed
Epistemonikos ID: a12e2e7a5f1cc5fc069f9587ea6aeab1217ed473
First added on: Oct 08, 2026