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

NCT03914924 | Active Not Recruiting

• 1 other identifier: DiabetesCollegeBrazil
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 2

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.

Conditions

Diabetes Mellitus; Prediabetes

Keywords

Diabetes Mellitus; Exercise; Health Education; Patient Education; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Health Behavior: health literacy

  Change from Baseline health literacy at 12 weeks (post-intervention assessment) and 6 months (follow-up assessment)

• Health Behavior: physical activity level

  Change from Baseline physical activity 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)

• Health Behavior: medication adherence

  Change from Baseline Medication adherence at 12 weeks (post-intervention assessment) and 6 months (follow-up assessment)

Other Outcomes (6)

• Program adherence

  12 weeks (post-intervention assessment).

• Satisfaction with the program

  12 weeks (post-intervention assessment).

• Quality of life level

  Change from Baseline Quality of life at 12 weeks (post-intervention assessment) and 6 months (follow-up assessment)

Study Arms (2)

Exercise Program

ACTIVE COMPARATOR

Ex: The participants will be submitted to only a 12-week exercise intervention.

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.

Behavioral: Exercise Program; Behavioral: Lifestyle Education Program

Interventions

Exercise Program BEHAVIORAL

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.

Exercise Program; Exercise and Lifestyle Education Program

Lifestyle Education Program BEHAVIORAL

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.

Exercise and Lifestyle Education Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Federal University of Juiz de Fora: lead
• Federal University of Minas Gerais: collaborator
• Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.: collaborator
• Fundação de Amparo à Pesquisa do estado de Minas Gerais: collaborator

Study Sites (2)

Federal University of Minas Gerais

Belo Horizonte, Minas Gerais, 31270-901, Brazil

Location

Federal University of Juiz de Fora

Juiz de Fora, Minas Gerais, 36038330, Brazil

Location

Related Publications (15)

• 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.

  PMID: 29222369 BACKGROUND

• Sociedade Brasileira de Diabetes. 2017. "Diretrizes Da Sociedade Brasileira de Diabetes 2017-2018." (D): 257-63.

  BACKGROUND

• 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.

  PMID: 29496507 RESULT

• 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.

  PMID: 24070883 RESULT

• 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.

  PMID: 30606177 RESULT

• 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.

  PMID: 28226200 RESULT

• 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.

  PMID: 30282639 RESULT

• 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.

  PMID: 33520812 RESULT

• 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.

  PMID: 33824060 RESULT

• 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.

  PMID: 34186358 RESULT

• 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.

  PMID: 34174860 RESULT

• 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.

  PMID: 36115088 RESULT

• 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.

  PMID: 36554577 RESULT

• 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.

  PMID: 24553698 RESULT

• Silva 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.

  PMID: 39434107 DERIVED

Related Links

• Diabetes College

MeSH Terms

Conditions

Diabetes Mellitus; Prediabetic State; Motor Activity; Health Education

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior; Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Lilian P da Silva, PhD

  University Federal of Juiz de Fora

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Principal Investigator

Model Details: Participants will be randomly allocated to one of two interventions: Exercise Program (Ex) or Exercise and Lifestyle Education Program (ExLE).

Study Record Dates

• First Submitted: April 4, 2019
• First Posted: April 16, 2019
• Study Start: January 20, 2020
• Primary Completion: December 20, 2024
• Study Completion: May 30, 2025
• Last Updated: July 1, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)