Diabetes MellitusNCT03914924
Effects of an Exercise and Lifestyle Education Program for People With Diabetes and Prediabetes
A study testing Exercise Program and Lifestyle Education Program in people with Diabetes Mellitus and Prediabetes, run by Federal University of Juiz de Fora at 2 sites in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Prediabetes
- What is being tested?
- Exercise Program and Lifestyle Education Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 2 sitesBrazil
- Study dates
- 20 Jan 2020to 30 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Federal University of Minas Gerais
Belo Horizonte, Minas Gerais, 31270-901
Federal University of Juiz de Fora
Juiz de Fora, Minas Gerais, 36038330
About this study
Official title: Effects of an Exercise and Lifestyle Education Program for People With Diabetes and Prediabetes: A Multicenter Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Diabetes Mellitus, Prediabetes
- Being tested
- Exercise Program, Lifestyle Education Program
- Keywords
- Diabetes Mellitus, Exercise, Health Education, Patient Education, Randomized Controlled Trial
- Medical subject headings
- Diabetes Mellitus, Prediabetic State, Motor Activity, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise ProgramBehavioural
On-site delivery: The supervised exercise sessions will be offered twice a week from the first to fourth weeks and once a week from the fifth week onwards. Each session lasts approximately 60 minutes.
Remote delivery: The participants will attend an initial supervised exercise session delivered on-site. After this session, they will receive the exercise intervention through a website specific to the Ex program. Participants will receive weekly WhatsApp messages to remind them about the exercise routine.
Independent of the delivery format all participants will receive counseling to accumulate at least 150 min of aerobic exercise per week.
Lifestyle Education ProgramBehavioural
On-site delivery: The supervised exercise sessions will be offered twice a week from the first to fourth weeks and once a week from the fifth week onwards. Each session will last approximately 60 minutes. Participants will receive a printed version of the Diabetes College Guide containing twenty chapters and they will attend eighteen thirty-minute education classes.
Remote delivery: The participants will attend an initial supervised exercise session delivered on-site. After this session, they will receive the interventions (exercise and education) through a website specific to the ExLE program. Participants will receive a printed version of the Diabetes College Guide, as well as, guidance on accessing the educational content on the website and weekly WhatsApp messages with reminders about educational content scheduled for that week.
Independent of the delivery format all participants will receive counseling to accumulate at least 150 min of aerobic exercise per week.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Program | Active comparator | Ex: The participants will be submitted to only a 12-week exercise intervention. Receives: Behavioral: Exercise Program |
| Exercise and Lifestyle Education Program | Experimental | ExLE: The participants will be submitted to a 12-week intervention consisting of exercise and education. Receives: Behavioral: Exercise Program; Behavioral: Lifestyle Education Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional capacity
This outcome will be measured by the Incremental Shuttle Walk Test (ISWT) distance.
Measured: 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.
Measured: Change from Baseline Disease-related knowledge at 12 weeks (post-intervention assessment) and 6 months (follow-up assessment).
Secondary outcomes (8)
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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 the total score of the Brazilian version of the Measure of Adherence to Oral Antidiabetic and Insulin Treatments questionnaire (MAT ADOs and MAT insulin), consisting of 7 items. The total score is determined by the average of scores obtained for each item.Higher scores mean more adherence.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from Baseline Cardiac autonomic control at 12 weeks (post-intervention assessment) and 6 months (follow-up assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study start20 Jan 2020
- Primary completion20 Dec 2024 (estimated)
- Study completion30 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly allocated to one of two interventions: Exercise Program (Ex) or Exercise and Lifestyle Education Program (ExLE).
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Juiz de Fora
- Sponsor type
- University, hospital or other
- Collaborators
- Federal University of Minas Gerais, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Fundação de Amparo à Pesquisa do estado de Minas Gerais
- Responsible party
- Principal investigator, Lilian Pinto da Silva, Federal University of Juiz de Fora
- Investigators
- Lilian P da Silva, PhD, Principal investigator, University Federal of Juiz de Fora
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03914924
- Sponsor's protocol ID
- DiabetesCollegeBrazil
- Status last verified
- Jun 2024
- First submitted
- 4 Apr 2019
- Last updated
- 1 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29222369Sociedade Brasileira de Diabetes. 2017. "Diretrizes Da Sociedade Brasileira de Diabetes 2017-2018." (D): 257-63.
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.
PubMed 29496507Fiocco 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.
PubMed 24070883Kuziemski 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.
PubMed 30606177Odgers-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.
PubMed 28226200Chaves 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.
PubMed 30282639Machado 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.
PubMed 33520812Felix 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.
PubMed 33824060Teixeira 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.
PubMed 34186358Ghisi 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.
PubMed 34174860Seixas 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.
PubMed 36115088Seixas 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.
PubMed 36554577Boas 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.
PubMed 24553698Silva LPD, Batalha APDB, Ghisi GLM, Seixas MB, Cisneros LL, Jansen AK, Moreira APB, Pereira DS, Britto RR, Pereira DAG, Trevizan PF, Oh P. Effects of an Exercise and Lifestyle Education Program in Brazilians living with prediabetes or diabetes: study protocol for a multicenter randomized controlled trial. Trials. 2024 Oct 21;25(1):701. doi: 10.1186/s13063-024-08535-6.
PubMed 39434107
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an Exercise and Lifestyle Education Program for People With Diabetes and Prediabetes: A Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03914924
- Acronym / sponsor ID
- DiabetesCollegeBrazil
- Conditions
- Diabetes Mellitus, Prediabetes
- Keywords
- Diabetes Mellitus, Exercise, Health Education, Patient Education, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Federal University of Juiz de ForaUniversity, hospital or other
- Collaborators
- Federal University of Minas Gerais, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Fundação de Amparo à Pesquisa do estado de Minas Gerais
- Study start
- 20 Jan 2020 (actual)
- Primary completion
- 20 Dec 2024 (estimated)
- Study completion
- 30 May 2025 (estimated)
- First posted
- 16 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly allocated to one of two interventions: Exercise Program (Ex) or Exercise and Lifestyle Education Program (ExLE).
| Arm | Type | Receives |
|---|---|---|
| Exercise Program | Active comparator | Behavioral: Exercise ProgramEx: The participants will be submitted to only a 12-week exercise intervention. |
| Exercise and Lifestyle Education Program | Experimental | Behavioral: Exercise Program, Behavioral: Lifestyle Education ProgramExLE: The participants will be submitted to a 12-week intervention consisting of exercise and education. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise ProgramOn-site delivery: The supervised exercise sessions will be offered twice a week from the first to fourth weeks and once a week from the fifth week onwards. Each session lasts approximately 60 minutes. Remote delivery: The participants will attend an initial supervised exercise session delivered on-site. After this session, they will receive the exercise intervention through a website specific to the Ex program. Participants will receive weekly WhatsApp messages to remind them about the exercise routine. Independent of the delivery format all participants will receive counseling to accumulate at least 150 min of aerobic exercise per week. | Behavioural | Exercise Program, Exercise and Lifestyle Education Program |
| Lifestyle Education ProgramOn-site delivery: The supervised exercise sessions will be offered twice a week from the first to fourth weeks and once a week from the fifth week onwards. Each session will last approximately 60 minutes. Participants will receive a printed version of the Diabetes College Guide containing twenty chapters and they will attend eighteen thirty-minute education classes. Remote delivery: The participants will attend an initial supervised exercise session delivered on-site. After this session, they will receive the interventions (exercise and education) through a website specific to the ExLE program. Participants will receive a printed version of the Diabetes College Guide, as well as, guidance on accessing the educational content on the website and weekly WhatsApp messages with reminders about educational content scheduled for that week. Independent of the delivery format all participants will receive counseling to accumulate at least 150 min of aerobic exercise per week. | Behavioural | Exercise and Lifestyle Education Program |
Primary outcome
Functional capacity
Time frame: 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
Time frame: 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.
8 secondary outcomes
Health Behavior: health literacy
Time frame: Change from Baseline health literacy at 12 weeks (post-intervention assessment) and 6 months (follow-up assessment)
Health Behavior: physical activity level
Time frame: Change from Baseline physical activity at 12 weeks (post-intervention assessment) and 6 months (follow-up assessment)
Health Behavior: exercise self-efficacy
Time frame: 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
Time frame: 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
Time frame: Change from Baseline Medication adherence at 12 weeks (post-intervention assessment) and 6 months (follow-up assessment)
Cardiometabolic Health Parameter: glycemic control
Time frame: Change from Baseline blood sugar level at 12 weeks (post-intervention assessment) and 6 months (follow-up assessment)
Cardiometabolic Health Parameter: anthropometric characteristics
Time frame: 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
Time frame: Change from Baseline Cardiac autonomic control at 12 weeks (post-intervention assessment) and 6 months (follow-up assessment)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2024.
- Background: PubMed 29222369Introduction: Standards of Medical Care in Diabetes-2018. Diabetes Care. 2018 Jan;41(Suppl 1):S1-S2. doi: 10.2337/dc18-Sint01. No abstract available.
- BackgroundSociedade Brasileira de Diabetes. 2017. "Diretrizes Da Sociedade Brasileira de Diabetes 2017-2018." (D): 257-63.
- Results publication: PubMed 29496507Cho 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.
- Results publication: PubMed 24070883Fiocco 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.
- Results publication: PubMed 30606177Kuziemski 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.
- Results publication: PubMed 28226200Odgers-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.
- Results publication: PubMed 30282639Chaves 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.
- Results publication: PubMed 33520812Machado 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.
- Results publication: PubMed 33824060Felix 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.
- Results publication: PubMed 34186358Teixeira 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.
- Results publication: PubMed 34174860Ghisi 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.
- Results publication: PubMed 36115088Seixas 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.
- Diabetes CollegeLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Diabetes Mellitus
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lilian P da Silva, PhD principal investigator
University Federal of Juiz de Fora
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Program and Lifestyle Education Program in people with Diabetes Mellitus and Prediabetes, run by Federal University of Juiz de Fora at 2 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional capacity (time frame: Change from Baseline Functional Capacity at 12 weeks (post-intervention assessment) and 6 months (follow-up assessment)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03914924, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2024.