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

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

Interventions

BEHAVIORAL

Exercise Program

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.

BEHAVIORAL

Lifestyle Education Program

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.

Sponsors & Collaborators

• Federal University of Minas Gerais

  collaborator OTHER

• Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

  collaborator OTHER_GOV

• Fundação de Amparo à Pesquisa do estado de Minas Gerais

  collaborator OTHER

• Federal University of Juiz de Fora

  lead OTHER

Principal Investigators

• Lilian P da Silva, PhD · University Federal of Juiz de Fora

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-01-20

Primary Completion

2024-12-20

Completion

2025-05-30

Countries

• Brazil

Study Locations