Effects of an Exercise and Lifestyle Education Program for People With Diabetes and Prediabetes: A Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 240
- 试验地点
- 4
- 主要终点
- Functional capacity
研究概览
简要总结
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-month follow-up.
详细描述
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%, a 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 public and private health services in two Brazilian cities (Belo Horizonte and Juiz de Fora). Volunteers will be allocated to participate in the program to which they were randomized 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), post-intervention, and 6 months post-program completion.
The baseline 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 the baseline assessment. Eligible participants will be randomized to one of the 2 programs (Ex or ExLE). 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 programs (Ex and ExLE) will be delivered on-site or remotely based on internet access and technology literacy screening. Participants who attend these two conditions can choose the delivery format by which they would like to receive the program interventions. For those with no internet access and/or technology literacy, the delivery format of the program interventions will be on-site.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult (> 18 years old);
- •Self-reported current history of prediabetes or Diabetes Mellitus (type 1 or type 2);
- •No cognitive limitation (score ≥ 4 in the six-item screener);
- •No vision limitations for reading;
- •Literate;
- •Written physician permission for exercising;
- •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.
排除标准
- •Clinical decompensation that contraindicates the performance of physical exercises;
- •Physical and/or mental limitations that will prevent the participant from physically exercising and/or understanding educational content;
- •Complex ventricular arrhythmias (i.e., atrial flutter or atrial fibrillation, multiple atrial or ventricular ectopy, and atrioventricular or ventricular block).
结局指标
主要结局
Functional capacity
时间窗: Change from Baseline Functional Capacity at 12 weeks (post-intervention assessment) and 6 months (follow-up assessment)
This outcome will be measured by the Incremental Shuttle Walk Test (ISWT) distance.
Disease-related knowledge
时间窗: Change from Baseline Disease-related knowledge at 12 weeks (post-intervention assessment) and 6 months (follow-up assessment).
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.
次要结局
- Health Behavior: physical activity level(Change from Baseline physical activity at 12 weeks (post-intervention assessment) and 6 months (follow-up assessment))
- Health Behavior: health literacy(Change from Baseline health literacy at 12 weeks (post-intervention assessment) and 6 months (follow-up assessment))
- Cardiometabolic Health Parameter: glycemic control(Change from Baseline blood sugar level at 12 weeks (post-intervention assessment) and 6 months (follow-up assessment))
- Health Behavior: 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(Change from baseline adherence to standard Mediterranean food elements at 12 weeks (post-intervention assessment) and 6 months (follow-up assessment))
- Cardiometabolic Health Parameter: anthropometric characteristics(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(Change from Baseline Cardiac autonomic control at 12 weeks (post-intervention assessment) and 6 months (follow-up assessment))
- Health Behavior: medication adherence(Change from Baseline Medication adherence at 12 weeks (post-intervention assessment) and 6 months (follow-up assessment))
研究者
Lilian Pinto da Silva
Professor, Principal Investigator
Federal University of Juiz de Fora