Effects of an Exercise and Lifestyle Education Program for Diabetics and Prediabetics

Summary

Participation Requirements

Description

The design is a multicenter, double-blind (outcomes assessors and data analysts), randomized and controlled trial with 2 parallel arms: Exercise Program (Ex) and Exercise and Lifestyle Education Program (ExLE). The sample size was calculated considering the ISWT distance as the primary outcome and b...

The design is a multicenter, double-blind (outcomes assessors and data analysts), randomized and controlled trial with 2 parallel arms: Exercise Program (Ex) and Exercise and Lifestyle Education Program (ExLE). The sample size was calculated considering the ISWT distance as the primary outcome and based on a previous study that tested the effects of a comprehensive cardiac rehabilitation program on the same primary outcome in coronary patients. The calculation was made using R Software version 3.4.3 and considering the following parameters: moderate effect size (d = 0.20), the statistical power of 80%, an alpha level of 5%, one-sided test, two arms, and three measurements. A total of 200 participants (100 per program) was required and assuming a 20% attrition rate based on previous studies using educational intervention in Cardiac Rehabilitation patients,42 it will take 120 participants in each program to sign the consent form in order to have 200 participants who will complete the study. Adults with diabetes and prediabetes will be recruited from the public and private health services in two Brazilian cities (Belo Horizonte and Juiz de Fora). Volunteers will participate in the interventions for 12 weeks and will be invited for follow-up and reassessment after 6 months of program completion. In this sense, three assessments will be performed: pre-intervention (baseline), after 12 weeks of intervention and 6 months post-program completion. The initial assessment will comprise an interview to obtain their clinical characteristics and sociodemographic data, medical history, vital signs measurement, electrocardiographic monitoring and measurement of primary, secondary and tertiary outcomes (other pre-specified outcome measures) through questionnaires and specific tests. The number of patients approached and date will be recorded, as well as the reasons for inclusion/exclusion. With informed written consent from the patient, potentially eligible participants will be scheduled to come on-site to complete initial assessments. Eligible participants will be randomized to one of the 2 groups. The generation of the randomized allocation sequence will be performed by the project coordinator using the software available on the website www.randomization.com. To ensure allocation concealment, the local research coordinators have the allocation sequence in a password-protected file, and will only provide randomization information to the research team member once it is confirmed the participant is eligible. Due to the nature of the intervention, participants and the research team members cannot be blind to treatment allocated. However, an independent research member who will be blinded to the group allocation will perform database management and analyses. The group Ex and ExLE participants will be submitted to a supervised and individually prescribed exercise program consisting of aerobic (walking) and muscle-strengthening exercise sessions. This exercise program is 12 weeks in duration with 16 exercise sessions of approximately 1 hour offered at the following frequencies: Stage 1: 4 weeks - supervised exercise sessions 2x/week Stage 2: 8 weeks - supervised exercise sessions 1x/week Each session will be constituted by moderate-intensity walking and muscle strength exercises that encompass the main muscle groups, using bodyweight or elastic bands. In addition, they will receive counseling for unsupervised exercise sessions in their community to aim to accumulate a minimum of 150 min/week. Participants in ExLE also attend education classes using the educational curriculum of Diabetes College offered through different tools including website, patient workbook and learning management. Education classes will be delivered by a health educator team post each exercise session and participants receive a comprehensive education workbook to accompany the sessions. The workbook was developed by Diabetes College group researchers in Canada and the English version has been translated and culturally adapted to Brazilian Portuguese. This tool titled "A Guide to Help You Live and Thrive with Diabetes" or "Guia para Uma Vida Plena com Diabetes", contains 20 chapters, developed by a multi-disciplinary committee of health professionals and based on diabetes patients' needs. Chapters are organized into 5 sections: treat diabetes, get active, eat healthy, feel well, and take control. In total there will be offered 18 educational sessions since there will be an initial extra class to program introduction and an extra final class to program graduation. Diabetes College is an educational program that helps people live and thrive with diabetes. The program development was based on patients' educational needs (assessed by the information needs assessment and focus groups) in the University Health Network in Toronto/Canada. This program can help diabetes patients to improve their health and functional capacity, make lifestyle changes, take control of their blood sugar and prevent diabetes (if they have prediabetes). These objectives can be achieved by teaching patients what diabetes is and how it impacts their health, how diabetes medicines work and help control blood sugar, and how to make lifestyle changes to take control of their health. All participants will be invited to the follow-up after completion of the interventions. During the 6-month follow-up, participants will be instructed to record their Diabetes-related morbidity information on the standardized sheet developed by the research team. Research team members will make monthly phone calls to participants to remind them to perform this registration properly. Besides that, to minimize drop-outs to follow-up, the research team members will send email and phone reminders for patients about to come on-site to the 6-month follow-up assessment post-intervention.

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