Remote and Intensive Program for Physical Activity Promotion for People With Type 2 Diabetes (The PRACTICE Trial)

NCT ID: NCT05347862

Last Updated: 2022-12-02

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 344 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-02
• Study Completion Date: 2025-12-30

Brief Summary

The purpose of this trial is to evaluate the effects of a remote and intensive physical activity promotion program for people with Type 2 Diabetes (T2D), in comparison to a usual model of PA counseling, in glycemic levels, level of physical activity and quality of life in adults in elderly with T2D.

Detailed Description

The PRACTICE Trial aims to assess the effectiveness of a remote and intensive physical activity promotion program in contrast to the usual advice for physical activity on the management of HbA1c in people with T2DM.

The duration of the trial will be 24 weeks. Participants will be allocated to the intervention group or control group. The data collection will include variables related to (a) physical activity levels; (b) quality of life; (c) self-care in T2D; (d) functional capacity levels; and (e) adverse events related or not to the study.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control group

Usual standard advice to practice physical activity as an important measure to promote health benefits.

Group Type: OTHER

Control group

Intervention Type: OTHER

At baseline, this group will receive only the usual standard advice to practice physical activity as an important measure to promote health benefits. During the intervention period, they will receive only telephone calls monthly to assess the physical activity practice, changes in medication, and adverse events. When appropriate, evaluations of 12 and 24 weeks will be scheduled.

Physical Activity Promotion

The intervention will consist of telephone calls and text messages to promote the practice of 150 minutes/week of physical activity in the daily life of participants.

Group Type: EXPERIMENTAL

Physical activity promotion

Intervention Type: OTHER

The intervention will be based on a remote approach, for 24 weeks. The intervention will consist of telephone calls and sent messages to promote the practice of 150 minutes/week of physical activity in the daily life of participants, plus short text messages promoting health behaviors related to self-care, nutrition, physical activity, and sedentary behavior.

Initially, this group will be followed weekly during the first 4 weeks. After this period this group can up to two weekly calls, according to their preference. The text messages will be weekly. During the telephone calls, the research team will verify the volume of PA achieved and help the participants to identify and overcome barriers to PA practice, and motivate and register any adverse events related or not to the study.

Interventions

Control group

At baseline, this group will receive only the usual standard advice to practice physical activity as an important measure to promote health benefits. During the intervention period, they will receive only telephone calls monthly to assess the physical activity practice, changes in medication, and adverse events. When appropriate, evaluations of 12 and 24 weeks will be scheduled.

Intervention Type: OTHER

Physical activity promotion

The intervention will be based on a remote approach, for 24 weeks. The intervention will consist of telephone calls and sent messages to promote the practice of 150 minutes/week of physical activity in the daily life of participants, plus short text messages promoting health behaviors related to self-care, nutrition, physical activity, and sedentary behavior.

Initially, this group will be followed weekly during the first 4 weeks. After this period this group can up to two weekly calls, according to their preference. The text messages will be weekly. During the telephone calls, the research team will verify the volume of PA achieved and help the participants to identify and overcome barriers to PA practice, and motivate and register any adverse events related or not to the study.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Eighteen years of age or older;
• Glycated hemoglobin ≥ 8.0%;
• Being a resident in Porto Alegre or metropolitan areas (Viamão, Alvorada, Cachoeirinha, or Canoas);
• Eligibility to perform physical activity after cardiovascular risk assessment;
• Have some means of access to the internet (direct access or via a family member who can receive the research material and share the information/material sent with the participant).

Exclusion Criteria

• Physically active, that is, performing at least 150 minutes of moderate to vigorous PA per week;
• Not having their own cell phone capable of receiving calls and text messages;
• Progressive neurological disorder (e.g., Parkinsonism, Alzheimer's Disease);
• Psychiatric disorder that makes the intervention unfeasible;
• Physical, language, hearing, vision or cognition disorder that makes it impossible to attend the evaluations and carry out the intervention;
• Severe cardiovascular disease (class III and IV heart failure, unstable angina), history of macrovascular event in the last 12 months (acute myocardial infarction, revascularization procedures, deep vein thrombosis, stroke or pulmonary embolism);
• Joint, muscle or bone injury that makes the intervention unfeasible;
• Planning to move to cities outside the geographic area where the study is carried out;
• Inadequate control of comorbidities. Resting systolic blood pressure >180 mmHg and/or resting diastolic blood pressure >100 mmHg;
• Physical limitation that makes it impossible or brings risk to the participant's practice (e.g. lower limb amputation that makes locomotion difficult, use of crutches, cane).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federal University of Rio Grande do Sul

OTHER

Sponsor Role: collaborator

Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

Sponsor Role: collaborator

Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel Umpierre, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital de Clínicas de Porto Alegre

Locations

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Countries

Brazil

Central Contacts

Daniel Umpierre, PhD

Role: CONTACT

danielumpierre@hcpa.edu.br

555133596332

Jayne Santos Leite, Master

Role: CONTACT

jsleite@hcpa.edu.br

555133596332

Facility Contacts

Daniel Umpierre, PhD

Role: primary

danielumpierre@hcpa.edu.br

555133596332

Jayne Santos Leite, MSc

Role: backup

jsleite@hcpa.edu.br

555133596332

Related Links

https://osf.io/npxdw/

Study repository - Open Science Framework

Other Identifiers

20210394

Identifier Type: -

Identifier Source: org_study_id