Content area
Background
Patient education is a crucial strategy for promoting prevention and diabetes self-management since glycemic control achievement involves taking medications, medical nutrition therapy, physical exercise, and behavior changes. However, patient education programs are still barely implemented in low- and middle-income countries. This trial aims to investigate whether a lifestyle education intervention added to physical exercising is superior to sole physical exercising regarding functional capacity, disease-related knowledge, health behaviors, cardiometabolic health parameters, quality of life, depression, and diet quality in individuals with prediabetes or diabetes.
Methods
Multicenter double-blinded randomized controlled trial with two parallel arms involving 12-week intervention and 6-month follow-up. The eligible individuals (≥ 18 years, living with prediabetes or diabetes, literate, no clinical decompensation and/or physical and/or mental limitations that contraindicate physical exercising, written physician permission for exercise, no cognitive impairment, no vision limitations for reading, no confirmed diagnosis of unstable coronary disease or heart failure, no pacemaker and/or implantable cardioverter-defibrillator, no complex ventricular arrhythmias, no intermittent claudication, no recent cardiovascular event or cardiac surgery, and no currently enrolled in a structured exercise program) were recruited from two Brazilian cities and randomized to either (1) an Exercise and Lifestyle Education Program (ExLE) or (2) an Exercise Program (Ex), which can be delivered on-site or remotely based on the participants’ internet access and technology literacy. The primary outcomes will be changes in functional capacity and disease-related knowledge. The secondary outcomes will involve changes in health behaviors (health literacy, physical activity level, exercise self-efficacy, and medication adherence) and cardiometabolic health parameters (glycemic control, anthropometric measures, and cardiac autonomic control). Program adherence, satisfaction with the program, diabetes-related morbidity, and changes in quality of life, depression, and diet quality will be the tertiary outcomes. Assessments will occur at baseline, post-intervention, and after 6-month follow-up.
Discussion
If superior effectiveness of ExLE compared to Ex program to improve the outcomes measures is found, this program could be delivered broadly in the Brazilian health system, especially in the primary care facilities where most individuals living with prediabetes and diabetes in our country are assisted.
Trial registration
ClinicalTrials.gov, NCT03914924. Registered on April 16, 2019.
Details
Exercise;
Diabetes;
Physical fitness;
Curricula;
Nutrition;
Clinical trials;
Cardiovascular disease;
Public health;
Health care networks;
Rehabilitation;
Data collection;
Physical therapy;
Disease prevention;
Industrialized nations;
Cognitive ability;
Patient education;
Lifestyles;
Physical education
; Batalha, Ana Paula Delgado Bomtempo 2 ; Ghisi, Gabriela Lima de Melo 3 ; Seixas, Mariana Balbi 4 ; Cisneros, Ligia Loiola 5 ; Jansen, Ann Kristine 6 ; Moreira, Ana Paula Boroni 7 ; Pereira, Daniele Sirineu 5 ; Britto, Raquel Rodrigues 5 ; Pereira, Danielle Aparecida Gomes 5 ; Trevizan, Patrícia Fernandes 5 ; Oh, Paul 8 1 Federal University of Juiz de Fora, Faculty of Physical Therapy, Juiz de Fora, Brazil (GRID:grid.412368.a) (ISNI:0000 0004 0643 8839); Federal University of Juiz de Fora, Graduate Program in Physical Education, Faculty of Physical Education and Sports, Juiz de Fora, Brazil (GRID:grid.411198.4) (ISNI:0000 0001 2170 9332)
2 Federal University of Juiz de Fora, Graduate Program in Physical Education, Faculty of Physical Education and Sports, Juiz de Fora, Brazil (GRID:grid.411198.4) (ISNI:0000 0001 2170 9332)
3 KITE Research Institute, University Health Network, University of Toronto, Toronto, Canada (GRID:grid.231844.8) (ISNI:0000 0004 0474 0428)
4 Federal University of Juiz de Fora, Faculty of Physical Therapy, Juiz de Fora, Brazil (GRID:grid.412368.a) (ISNI:0000 0004 0643 8839)
5 Federal University of Minas Gerais, Department of Physical Therapy, Belo Horizonte, Brazil (GRID:grid.8430.f) (ISNI:0000 0001 2181 4888)
6 Federal University of Minas Gerais, Department of Nutrition, Belo Horizonte, Brazil (GRID:grid.8430.f) (ISNI:0000 0001 2181 4888)
7 Federal University of Juiz de Fora, Department of Nutrition, Juiz de Fora, Brazil (GRID:grid.412368.a) (ISNI:0000 0004 0643 8839)
8 KITE Research Institute, University Health Network, University of Toronto, Toronto, Canada (GRID:grid.231844.8) (ISNI:0000 0004 0474 0428); Toronto Rehabilitation Institute, University Health Network, Cardiovascular Rehabilitation and Prevention Program, Toronto, Canada (GRID:grid.415526.1) (ISNI:0000 0001 0692 494X)