Remote and Intensive Program for Physical Activity Promotion for People With Type 2 Diabetes (The PRACTICE Trial)
PRACTICE
1 other identifier
interventional
344
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable type-2-diabetes
Started Dec 2022
Typical duration for not_applicable type-2-diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 14, 2022
CompletedFirst Posted
Study publicly available on registry
April 26, 2022
CompletedStudy Start
First participant enrolled
December 2, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2025
CompletedDecember 2, 2022
December 1, 2022
3.1 years
April 14, 2022
December 1, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Physical Activity Levels
Baseline; 12 weeks; 24 weeks.
Sitting time
Baseline; 12 weeks; 24 weeks.
Medication changes
Monthly, up to 24 weeks.
Short Form Health Survey (SF-36)
Baseline; 12 weeks; 24 weeks.
Other Outcomes (3)
Blood pressure
Baseline; 12 weeks; 24 weeks.
Walking capacity
Baseline; 12 weeks; 24 weeks.
Handgrip strength
Baseline; 12 weeks; 24 weeks.
Study Arms (2)
Control group
OTHERUsual standard advice to practice physical activity as an important measure to promote health benefits.
Physical Activity Promotion
EXPERIMENTALThe 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-007, Brazil
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Daniel Umpierre, PhD
Hospital de Clínicas de Porto Alegre
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Single-blind masking
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 14, 2022
First Posted
April 26, 2022
Study Start
December 2, 2022
Primary Completion
December 30, 2025
Study Completion
December 30, 2025
Last Updated
December 2, 2022
Record last verified: 2022-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- The individual participant dataset will become available in a public repository up to six months after the first study publication.
- Access Criteria
- A simple registration will grant access to study datasets. The website for these files is not defined at the time of registration.
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.