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

Primary Purpose

Type 2 Diabetes

Status
Not yet recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Control group
Physical activity promotion
Sponsored by
Hospital de Clinicas de Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring Type 2 diabetes mellitus, randomized controlled trial, physical activity, aging, pragmatic clinical trial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Hospital de Clínicas de Porto Alegre

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Control group

Physical Activity Promotion

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Physical Activity Levels
The levels of physical activity will be assessed using the International Physical Activity Questionnaire (IPAQ, Portuguese version).
Sitting time
The sitting time will be assessed using the International Physical Activity Questionnaire (IPAQ, Portuguese version).
Medication changes
Participants' reports of medication changes (increases, decreases, or no changes in medication treatment) during the intervention period.
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.

Full Information

First Posted
April 14, 2022
Last Updated
December 1, 2022
Sponsor
Hospital de Clinicas de Porto Alegre
Collaborators
Federal University of Rio Grande do Sul, Conselho Nacional de Desenvolvimento Científico e Tecnológico
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1. Study Identification

Unique Protocol Identification Number
NCT05347862
Brief Title
Remote and Intensive Program for Physical Activity Promotion for People With Type 2 Diabetes (The PRACTICE Trial)
Acronym
PRACTICE
Official Title
Remote and Intensive Program for Physical Activity Promotion for People With Type 2 Diabetes: a Pragmatic Clinical Trial - The PRACTICE Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 2, 2022 (Anticipated)
Primary Completion Date
December 30, 2025 (Anticipated)
Study Completion Date
December 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital de Clinicas de Porto Alegre
Collaborators
Federal University of Rio Grande do Sul, Conselho Nacional de Desenvolvimento Científico e Tecnológico

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
Type 2 diabetes mellitus, randomized controlled trial, physical activity, aging, pragmatic clinical trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Masking Description
Single-blind masking
Allocation
Randomized
Enrollment
344 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Other
Arm Description
Usual standard advice to practice physical activity as an important measure to promote health benefits.
Arm Title
Physical Activity Promotion
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Control group
Intervention Description
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
Intervention Name(s)
Physical activity promotion
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from Baseline Glycated Hemoglobin at 3 and 6 months
Description
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.
Time Frame
Baseline; 12 weeks; 24 weeks.
Secondary Outcome Measure Information:
Title
Physical Activity Levels
Description
The levels of physical activity will be assessed using the International Physical Activity Questionnaire (IPAQ, Portuguese version).
Time Frame
Baseline; 12 weeks; 24 weeks.
Title
Sitting time
Description
The sitting time will be assessed using the International Physical Activity Questionnaire (IPAQ, Portuguese version).
Time Frame
Baseline; 12 weeks; 24 weeks.
Title
Medication changes
Description
Participants' reports of medication changes (increases, decreases, or no changes in medication treatment) during the intervention period.
Time Frame
Monthly, up to 24 weeks.
Title
Short Form Health Survey (SF-36)
Description
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.
Time Frame
Baseline; 12 weeks; 24 weeks.
Other Pre-specified Outcome Measures:
Title
Blood pressure
Description
This outcome will be assessed by measuring systolic and diastolic blood pressure in accordance to clinical guidelines and using an automated oscillometric device.
Time Frame
Baseline; 12 weeks; 24 weeks.
Title
Walking capacity
Description
Total distance (in meters) performed during the six-minute walk test.
Time Frame
Baseline; 12 weeks; 24 weeks.
Title
Handgrip strength
Description
Maximum strength (in kgf) achieved by both hands in a handgrip test using a hand dynamometer.
Time Frame
Baseline; 12 weeks; 24 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel Umpierre, PhD
Phone
555133596332
Email
danielumpierre@hcpa.edu.br
First Name & Middle Initial & Last Name or Official Title & Degree
Jayne Santos Leite, Master
Phone
555133596332
Email
jsleite@hcpa.edu.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Umpierre, PhD
Organizational Affiliation
Hospital de Clínicas de Porto Alegre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de Clínicas de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90035-007
Country
Brazil
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Umpierre, PhD
Phone
555133596332
Email
danielumpierre@hcpa.edu.br
First Name & Middle Initial & Last Name & Degree
Jayne Santos Leite, MSc
Phone
555133596332
Email
jsleite@hcpa.edu.br

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data after will be shared after trial completion. Data usage will be under the PI's auspices, but restrictions or screenings will not be imposed upon data requests. Outcomes data and any deemed relevant support information (sociodemographic, clinical history and allocated groups) will be shared if available. Details regarding the study's design and statistical plan can be obtained consulting the trial's protocol (links to be added as soon as available). Data on other outcomes could be requested contacting the PI. Data access will be available after all participants completed the study and will remain accessible for as long as deemed necessary by the study's committee. Data sets, variables' dictionary and statistical analysis description will be made available online upon registration and acceptance of the study team's data sharing terms and policy.
IPD Sharing Time Frame
The individual participant dataset will become available in a public repository up to six months after the first study publication.
IPD Sharing Access Criteria
A simple registration will grant access to study datasets. The website for these files is not defined at the time of registration.
Links:
URL
https://osf.io/npxdw/
Description
Study repository - Open Science Framework

Learn more about this trial

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

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