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

Study Overview
=================
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.

Official Title
-----------------
Remote and Intensive Program for Physical Activity Promotion for People With Type 2 Diabetes: a Pragmatic Clinical Trial - The PRACTICE Trial

Conditions
-----------------
Type 2 Diabetes

Intervention / Treatment
-----------------
* Other: Control group
* Other: Physical activity promotion


Participation Criteria
=================
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).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a pragmatic trial to assess the effectiveness of a physical activity promotion program on reduction levels of glycated hemoglobin in patients with Type 2 diabetes.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Control group<br>Usual standard advice to practice physical activity as an important measure to promote health benefits. | Other: Control group<br>* 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.<br>|
| Experimental: Physical Activity Promotion<br>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. | Other: Physical activity promotion<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Glycated Hemoglobin at 3 and 6 months | Glycated hemoglobin (HbA1c) is the primary outcome used for the comparison of a remote and intensive physical activity promotion program compared with usual advice for physical activity. The minimum clinically important difference considered for the study design and sample size calculation was an HbA1c reduction of 0.50% in favor of the remote and intensive physical activity promotion program. | Baseline; 12 weeks; 24 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical Activity Levels | The levels of physical activity will be assessed using the International Physical Activity Questionnaire (IPAQ, Portuguese version). | Baseline; 12 weeks; 24 weeks. | 
| Sitting time | The sitting time will be assessed using the International Physical Activity Questionnaire (IPAQ, Portuguese version). | Baseline; 12 weeks; 24 weeks. | 
| Medication changes | Participants' reports of medication changes (increases, decreases, or no changes in medication treatment) during the intervention period. | Monthly, up to 24 weeks. | 
| Short Form Health Survey (SF-36) | This instrument is a self-administered 36-item questionnaire. The score of quality of life ranges from 0 to 100, in which higher scores are indicative of better quality of life. | Baseline; 12 weeks; 24 weeks. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Type 2 diabetes mellitus, randomized controlled trial, physical activity, aging, pragmatic clinical trial