Clinical trial NCT03914924: Effects of an Exercise and Lifestyle Education Program for People With Diabetes and Prediabetes
Official title: Effects of an Exercise and Lifestyle Education Program for People With Diabetes and Prediabetes: A Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Diabetes Mellitus
Prediabetes
Keywords: Diabetes Mellitus
Exercise
Health Education
Patient Education
Randomized Controlled Trial
Lead sponsor: Federal University of Juiz de Fora
Sponsor class: OTHER
Collaborators: name: Federal University of Minas Gerais
name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
name: Fundação de Amparo à Pesquisa do estado de Minas Gerais
First posted: 2019-04-16
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly allocated to one of two interventions: Exercise Program (Ex) or Exercise and Lifestyle Education Program (ExLE).
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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 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.

The 12-week exercise intervention consists of at least 150 min of aerobic exercise per week and 2 to 3 muscle-strengthening sessions per week from the 4th week of the intervention. The exercise sessions were structured in exercise sessions (on-site delivery) or exercise plans (remote delivery) as follows: warm-up (stretching exercises and slow walking), aerobic exercise (moderate-to-vigorous intensity walking according to the Borg rating of perceived exertion exercise scale modified), muscle-strengthening exercises (localized muscle endurance exercises that encompass the major muscle groups) and cool down (slow walking and stretching exercises). In the on-site delivery, participants will attend eighteen supervised exercise sessions and receive counseling for unsupervised physical exercise to accumulate at least 150 min/week. They should record their weekly exercise routine in an exercise diary. In the remote delivery, participants will access weekly exercise plans on the Ex program website, and only this program's participants will have access to this website link. They will also receive weekly follow-up text messages via WhatsApp with standardized reminders about exercise goals and the importance of keeping track of their exercise and reporting the exercise sessions in the exercise diary.

In addition to the exercise intervention, participants randomized to the ExLE program will receive a 12-week educational intervention developed based on the Diabetes CollegeTM curriculum (https://www.diabetescollege.ca), translated and culturally adapted for Brazilians living with diabetes and prediabetes. In the on-site delivery, participants will attend eighteen education classes based on the five pillars of Diabetes CollegeTM (treat diabetes, get active, eat healthy, feel well, and take control) and receive a printed version of the Patient Guide (A Guide to Help You Live and Thrive with Diabetes, containing 298 pages and 17 chapters organized into five sections). In the remote delivery, participants will access their weekly lesson plans on the ExLE program website, and only this program's participants will have access to this website link. The educational content consists of the following materials: (1) eighteen video lessons recorded by the research team based on the five pillars of Diabetes CollegeTM, lasting approximately 20 min; (2) twelve videos related to the topics of the week (THRiVE, i.e., videos that integrate principles of chronic disease management and behavior changes to help patients to develop self-management skills through goal setting and action planning); and (3) an printed version of the Patient Guide. In addition, as part of remote delivery, participants will receive weekly WhatsApp text messages from the research team to remind them about the materials in their lesson plan and the importance of keeping track of access to educational content and reporting it in the study diary.

All participants will be invited to the follow-up after the program's completion and the post-intervention assessment.

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 register properly. Besides that, to minimize dropouts 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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).

Primary outcomes:
measure: Functional capacity
timeFrame: Change from Baseline Functional Capacity at 12 weeks (post-intervention assessment) and 6 months (follow-up assessment)
measure: Disease-related knowledge
timeFrame: Change from Baseline Disease-related knowledge at 12 weeks (post-intervention assessment) and 6 months (follow-up assessment).
Secondary outcomes:
measure: Health Behavior: health literacy
timeFrame: Change from Baseline health literacy at 12 weeks (post-intervention assessment) and 6 months (follow-up assessment)
measure: Health Behavior: physical activity level
timeFrame: Change from Baseline physical activity at 12 weeks (post-intervention assessment) and 6 months (follow-up assessment)
measure: Health Behavior: exercise self-efficacy
timeFrame: Change from Baseline Exercise Self-efficacy at 12 weeks (post-intervention assessment) and 6 months (follow-up assessment)
measure: Health Behavior: adherence to standard Mediterranean food elements
timeFrame: Change from baseline adherence to standard Mediterranean food elements at 12 weeks (post-intervention assessment) and 6 months (follow-up assessment)
measure: Health Behavior: medication adherence
timeFrame: Change from Baseline Medication adherence at 12 weeks (post-intervention assessment) and 6 months (follow-up assessment)
measure: Cardiometabolic Health Parameter: glycemic control
timeFrame: Change from Baseline blood sugar level at 12 weeks (post-intervention assessment) and 6 months (follow-up assessment)
measure: Cardiometabolic Health Parameter: anthropometric characteristics
timeFrame: Change from Baseline BMI and waist circumference at 12 weeks (post-intervention assessment) and 6 months (follow-up assessment)
measure: Cardiometabolic Health Parameter: cardiac autonomic control
timeFrame: Change from Baseline Cardiac autonomic control at 12 weeks (post-intervention assessment) and 6 months (follow-up assessment)
Other outcomes:
measure: Program adherence
timeFrame: 12 weeks (post-intervention assessment).
measure: Satisfaction with the program
timeFrame: 12 weeks (post-intervention assessment).
measure: Quality of life level
timeFrame: Change from Baseline Quality of life at 12 weeks (post-intervention assessment) and 6 months (follow-up assessment)
measure: Depression
timeFrame: Change from baseline depression at 12 weeks (post-intervention assessment) and 6 months (follow-up assessment)
measure: Diet quality
timeFrame: Change from baseline diet quality at 6 months (follow-up assessment)
measure: Morbidity associated with diabetes
timeFrame: 6 months after post-intervention assessment (follow-up assessment).
Locations:
city: Belo Horizonte
country: Brazil
facility: Federal University of Minas Gerais
state: Minas Gerais
city: Juiz de Fora
country: Brazil
facility: Federal University of Juiz de Fora
state: Minas Gerais
Study officials:
affiliation: University Federal of Juiz de Fora
name: Lilian P da Silva, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Introduction: Standards of Medical Care in Diabetes-2018. Diabetes Care. 2018 Jan;41(Suppl 1):S1-S2. doi: 10.2337/dc18-Sint01. No abstract available.
citation: Sociedade Brasileira de Diabetes. 2017. "Diretrizes Da Sociedade Brasileira de Diabetes 2017-2018." (D): 257-63.
citation: Cho NH, Shaw JE, Karuranga S, Huang Y, da Rocha Fernandes JD, Ohlrogge AW, Malanda B. IDF Diabetes Atlas: Global estimates of diabetes prevalence for 2017 and projections for 2045. Diabetes Res Clin Pract. 2018 Apr;138:271-281. doi: 10.1016/j.diabres.2018.02.023. Epub 2018 Feb 26.
citation: Fiocco AJ, Scarcello S, Marzolini S, Chan A, Oh P, Proulx G, Greenwood C. The effects of an exercise and lifestyle intervention program on cardiovascular, metabolic factors and cognitive performance in middle-aged adults with type II diabetes: a pilot study. Can J Diabetes. 2013 Aug;37(4):214-219. doi: 10.1016/j.jcjd.2013.03.369. Epub 2013 Aug 2.
citation: Kuziemski K, Slominski W, Jassem E. Impact of diabetes mellitus on functional exercise capacity and pulmonary functions in patients with diabetes and healthy persons. BMC Endocr Disord. 2019 Jan 3;19(1):2. doi: 10.1186/s12902-018-0328-1.
citation: Odgers-Jewell K, Ball LE, Kelly JT, Isenring EA, Reidlinger DP, Thomas R. Effectiveness of group-based self-management education for individuals with Type 2 diabetes: a systematic review with meta-analyses and meta-regression. Diabet Med. 2017 Aug;34(8):1027-1039. doi: 10.1111/dme.13340. Epub 2017 Mar 20.
citation: Chaves GSDS, Ghisi GLM, Grace SL, Oh P, Ribeiro AL, Britto RR. Effects of comprehensive cardiac rehabilitation on functional capacity in a middle-income country: a randomised controlled trial. Heart. 2019 Mar;105(5):406-413. doi: 10.1136/heartjnl-2018-313632. Epub 2018 Oct 3.
citation: Machado CCDS, Malaguti C, Trevizan PF, Ezequiel DGA, Seixas MB, da Silva LP. Psychometric validation of the Brazilian Portuguese version of Bandura's exercise self-efficacy scale in diabetes patients. J Diabetes Metab Disord. 2020 Jul 15;19(2):925-932. doi: 10.1007/s40200-020-00581-6. eCollection 2020 Dec.
citation: Felix CMM, Ghisi GLM, Seixas MB, Batalha APDB, Ezequiel DGA, Trevizan PF, Pereira DAG, Silva LPD. Translation, cross-cultural adaptation, and psychometric properties of the Brazilian Portuguese version of the DiAbeTes Education Questionnaire (DATE-Q). Braz J Phys Ther. 2021 Sep-Oct;25(5):583-592. doi: 10.1016/j.bjpt.2021.03.003. Epub 2021 Mar 26.
citation: Teixeira RL, Jansen AK, Pereira DA, Ghisi GLM, Silva LPD, Cisneros LL, Britto RR. Brazilian Portuguese version of the Mediterranean diet scale: Translation procedures and measurement properties. Diabetes Metab Syndr. 2021 Jul-Aug;15(4):102165. doi: 10.1016/j.dsx.2021.06.002. Epub 2021 Jun 5.
citation: Ghisi GLM, Seixas MB, Pereira DS, Cisneros LL, Ezequiel DGA, Aultman C, Sandison N, Oh P, da Silva LP. Patient education program for Brazilians living with diabetes and prediabetes: findings from a development study. BMC Public Health. 2021 Jun 26;21(1):1236. doi: 10.1186/s12889-021-11300-y.
citation: Seixas MB, Pereira DAG, Ghisi GLM, Batalha APDB, Santos CVO, Ponciano IC, Oh P, Silva LPD. Exercise and Lifestyle Education program for Brazilians living with prediabetes and diabetes: A pilot randomized trial. Diabetes Metab Syndr. 2022 Oct;16(10):102614. doi: 10.1016/j.dsx.2022.102614. Epub 2022 Sep 6.
citation: Seixas MB, Ghisi GLM, Oh P, Pereira DS, Moreira APB, Jansen AK, Batalha APDB, Candido GDN, Almeida JA, Pereira DAG, Silva LPD. Feasibility of Remote Delivering an Exercise and Lifestyle Education Program for Individuals Living with Prediabetes and Diabetes in Brazil. Int J Environ Res Public Health. 2022 Dec 12;19(24):16697. doi: 10.3390/ijerph192416697.
citation: Boas LC, Lima ML, Pace AE. Adherence to treatment for diabetes mellitus: validation of instruments for oral antidiabetics and insulin. Rev Lat Am Enfermagem. 2014 Jan-Feb;22(1):11-8. doi: 10.1590/0104-1169.3155.2386.