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Exercise and Lifestyle Education program for Brazilians living with prediabetes and diabetes: A pilot randomized trial
Institution:1. Cardiovascular Research Unit and Exercise Physiology, University Hospital, Federal University of Juiz de Fora, Avenida Eugênio do Nascimento S/N, Juiz de Fora, MG, 36038-330, Brazil;2. Graduate Program in Physical Education, Faculty of Physical Education and Sports, Federal University of Juiz de Fora, Rua José Lourenço Kelmer, S/N, Juiz de Fora, MG, 36036-900, Brazil;3. Department of Physical Therapy, Federal University of Minas Gerais, Avenida Presidente Antônio Carlos, 6627 - Pampulha, Belo Horizonte, MG, CEP: 31270-901, Brazil;4. Cardiovascular Rehabilitation and Prevention Program, Toronto Rehabilitation Institute, University Health Network, 347 Rumsey Road, Toronto, ON, M4G 1R7, Canada;5. Graduate Program in Rehabilitation Sciences and Physical-Functional Performance, Faculty of Physical Therapy, Federal University of Juiz de Fora, Av. Eugênio do Nascimento S/N, Juiz de Fora, MG, 36038-330, Brazil;6. Graduate Program in Health, Faculty of Medicine, Federal University of Juiz de Fora, Av. Eugênio do Nascimento S/N, Juiz de Fora, MG, 36038-330, Brazil
Abstract:AimsTo test the Diabetes College Brazil Study feasibility, the acceptability of study interventions and their preliminary effectiveness, and describe the study protocol modifications due to the COVID-19 pandemic.MethodsSingle-center, double-blinded pilot randomized trial with two parallel groups, Exercise and Lifestyle Education (ExLE; 12-week exercise and educational interventions) and Exercise (Ex; 12-week exercise intervention only) involving patients with prediabetes or diabetes. Feasibility (eligibility, recruitment, retention, completeness of variables measures and participation rates), acceptability (satisfaction), and preliminary effectiveness of interventions (variables: functional capacity, physical activity (PA), exercise self-efficacy, diabetes knowledge, health literacy, adherence to Mediterranean food pattern, glycated hemoglobin (HbA1c), anthropometric measures, cardiac autonomic control, depression, and quality of life (QofL)).ResultsEligibility, recruitment, retention, participation in exercise sessions, and education classes rates were 17%, 93%,82%, 76%, and 71%, respectively. Missing data in the post-intervention assessment (PA, HbA1c, cardiac autonomic control, anthropometric measures, depression, and QofL) were mainly related to research procedure modifications. The interventions were highly acceptable, and most variables improved farther in the ExLE, with moderate effect sizes for PA, diabetes knowledge, health literacy, cardiac autonomic control, and QofL.ConclusionsThe Diabetes College Brazil Study is feasible, and the ExLE may benefit Brazilians living with prediabetes and diabetes.
Keywords:Diabetes mellitus  Prediabetes  Health education  Patient education  Exercise training
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