Effects of an Exercise and Lifestyle Education Program for People With Diabetes and Prediabetes

Study Overview
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Brief Summary
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The purpose of this trial is to pragmatically investigate whether participation of people with diabetes and prediabetes in an Exercise and Lifestyle Education Program (i.e., exercise and education classes) results in better functional capacity, disease-related knowledge and behavior, and cardiometabolic health parameters when compared to Exercise Program (i.e., exercise class only). In addition, the effects of these interventions will be evaluated on other outcomes: program adherence, satisfaction with the program, quality of life, diet quality, depression, and morbidity associated with diabetes in the 6 months follow-up.

Detailed Description
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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. Assuming a 20% attrition rate based on previous studies using educational intervention in Cardiac Rehabilitation patients, it will take 120 participants in each program to sign the consent form to have 200 participants 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 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, the date and the reasons for inclusion/exclusion will be registered. 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. They 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 the treatment allocated. However, an independent research member 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 encompassing 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 the website, patient workbook, and learning management. A health educator team will deliver education classes after 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 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 for program introduction and an extra final class for 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 improve their health and functional capacity, make lifestyle changes, control 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.

Official Title
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Effects of an Exercise and Lifestyle Education Program for People With Diabetes and Prediabetes: A Multicenter Randomized Controlled Trial

Conditions
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Diabetes Mellitus, Prediabetes

Intervention / Treatment
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* Behavioral: Exercise Program
* Behavioral: Lifestyle Education Program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult (> 18 years old); Clinical and laboratory diagnosis of Prediabetes or Diabetes Mellitus (type 1 or type 2); Clinical compensation (glycemic control); No cognitive limitation (score ≥ 4 in the six-item screener); No confirmed diagnosis of cardiovascular diseases such as unstable coronary artery disease (CAD), heart failure; use of a pacemaker and/or implantable cardioverter-defibrillator (ICD), intermittent claudication; no recent cardiovascular event or cardiac surgery (≤ 6 months); Participants not currently enrolled in a structured physical exercise program that follows diabetes guidelines. Exclusion Criteria: Clinical decompensation that contraindicates the performance of physical exercises (not glycemic control); Physical and/or mental limitations that will prevent the participant to perform physical exercises and/or understanding of educational content; Complex ventricular arrhythmias (i.e., atrial flutter or atrial fibrillation, multiple atrial or ventricular ectopy, and atrioventricular or ventricular block.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomly allocated to one of two interventions: Exercise Program (Ex) or Exercise and Lifestyle Education Program (ExLE).
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Exercise Program<br>Ex: The participants will be submitted to only exercise sessions for 12 weeks. | Behavioral: Exercise Program<br>* The 12-week program consisting of 16 exercise sessions in a total of supervised and individually prescribed aerobic and muscle-strengthening exercise of approximately 60 minutes duration. The exercise sessions will be delivered as follow: 4 weeks - supervised exercise sessions 2x / week 8 weeks - supervised exercise sessions 1x / week In addition, they will receive counseling for unsupervised exercise sessions in their community, to accumulate a minimum of 150 min/week.<br>|
| Experimental: Exercise and Lifestyle Education Program<br>ExLE: The participants will be submitted to exercise sessions and education classes for 12 weeks. | Behavioral: Exercise Program<br>* The 12-week program consisting of 16 exercise sessions in a total of supervised and individually prescribed aerobic and muscle-strengthening exercise of approximately 60 minutes duration. The exercise sessions will be delivered as follow: 4 weeks - supervised exercise sessions 2x / week 8 weeks - supervised exercise sessions 1x / week In addition, they will receive counseling for unsupervised exercise sessions in their community, to accumulate a minimum of 150 min/week.<br>Behavioral: Lifestyle Education Program<br>* The 12-week program consisting of 18 education classes of 30 minutes duration delivery by a health educator team. Participants receive a comprehensive education workbook to accompany the sessions, containing 20 chapters. The classes will be delivered as follow: initial class to program introduction 4 weeks - education classes 2x / week 8 weeks - education classes 1x / week final class to program graduation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional capacity | This outcome will be measured by the Incremental Shuttle Walk Test (ISWT) distance. | Change from Baseline Functional Capacity at 12 weeks (post-intervention assessment) and 6 months (follow-up assessment) | 
| Disease-related knowledge | This outcome will be assessed from the total score of the Brazilian Portuguese version of the DiAbeTes Education Questionnaire (DATE-Q). This questionnaire is a 20-item self-administered tool (answer options are: true or false or do not know) equally distributed in five domains (self-management, long-term complications, being active, healthy eating, and psychosocial well-being) based on the Diabetes College. The total score ranges from 0 to 20, and higher scores indicate better disease-related knowledge. | Change from Baseline Disease-related knowledge at 12 weeks (post-intervention assessment) and 6 months (follow-up assessment). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health Behavior: health literacy | This outcome will be measured by the Newest Vital Sign (NVS) tool score. This is a six-item toll regarding the information found on an accompanying nutrition label. Each correct response is worth one point with a total of six points possible. Scores equal or greater than four are evidence of adequate health literacy whereas scores below four are evidence of inadequate health literacy. | Change from Baseline health literacy at 12 weeks (post-intervention assessment) and 6 months (follow-up assessment) | 
| Health Behavior: physical activity level | This outcome will be measured from the total number of steps recorded by a pedometer during consecutive 7 days. For analysis of this outcome, the total number of steps recorded will be divided for seven in order to obtain the average number of steps/day for each participant. The level of physical activity will be classified from the average of steps/day, as follow: sedentary (<5000 steps/day); low active (5000-7499 steps/day); somewhat active (7500-9999 steps/day); active (≥10 000 steps/day) and highly active (>12 500 steps/day). | Change from Baseline physical activity at 12 weeks (post-intervention assessment) and 6 months (follow-up assessment) | 
| Health Behavior: exercise self-efficacy | This outcome will be assessed from the total score of the Brazilian Portuguese version of Bandura's exercise self-efficacy scale. This is an 18-item self-administered tool which item contents are related to situations that may compromise the adherence to regular physical exercising, e. g. when feeling tired or during the holidays. The respondent should indicate from 0 (no confident) to 100 (very confident) how much confidence he or she has about maintaining the physical exercise routine face of the situation described in that item. The total score is the average from the eighteen items scores, and higher total scores indicate great exercise self-efficacy. | Change from Baseline Exercise Self-efficacy at 12 weeks (post-intervention assessment) and 6 months (follow-up assessment) | 
| Health Behavior: adherence to standard Mediterranean food elements | This outcome will be assessed from the total score of the Brazilian Portuguese version of the Mediterranean diet scale (MDS). The MDS has 13 items which quantitatively assess adherence to standard Mediterranean food elements [21]. The answer options are dichotomous: yes and no. Some questions have pictures and examples to help participants to answer the questions. One point is scored for each yes answered. Total scores range from 0 to 13. Scores below 5 indicate poor adherence to the MedDiet, and scores greater than 10 indicate high adherence. | Change from baseline adherence to standard Mediterranean food elements at 12 weeks (post-intervention assessment) and 6 months (follow-up assessment) | 
| Health Behavior: medication adherence | This outcome will be assessed from participants responses to a Likert Scale (scored from 1 (I do not or rarely use the prescribed medication) to 5 (I do always use the prescribed medication)) and by a five-item tool developed by the research team regarding the regular use of medicines with yes or no response options. | Change from Baseline Medication adherence at 12 weeks (post-intervention assessment) and 6 months (follow-up assessment) | 
| Cardiometabolic Health Parameter: glycemic control | This outcome will be assessed from the glycated hemoglobin (A1c) level obtained in routine tests dated no more than three months before the study assessment point. | Change from Baseline blood sugar level at 12 weeks (post-intervention assessment) and 6 months (follow-up assessment) | 
| Cardiometabolic Health Parameter: anthropometric characteristics | This outcome will be measured by the body mass index (BMI - kg/m2) and the waist circumference. | Change from Baseline BMI and waist circumference at 12 weeks (post-intervention assessment) and 6 months (follow-up assessment) | 
| Cardiometabolic Health Parameter: cardiac autonomic control | This outcome will be assessed from heart rate variability (HRV) indexes. | Change from Baseline Cardiac autonomic control at 12 weeks (post-intervention assessment) and 6 months (follow-up assessment) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes Mellitus, Exercise, Health Education, Patient Education, Randomized Controlled Trial