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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Other: Control group; Other: Physical activity promotion

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.

• Study Type: Interventional
• Enrollment (Anticipated): 344
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Daniel Umpierre, PhD; Phone Number: 555133596332; Email: danielumpierre@hcpa.edu.br
• Study Contact Backup: Name: Jayne Santos Leite, Master; Phone Number: 555133596332; Email: jsleite@hcpa.edu.br

Study Locations

• Brazil
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90035-007
      • Hospital de Clínicas de Porto Alegre
      • Contact: Daniel Umpierre, PhD; Phone Number: 555133596332; Email: danielumpierre@hcpa.edu.br
      • Contact: Jayne Santos Leite, MSc; Phone Number: 555133596332; Email: jsleite@hcpa.edu.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Control group; Usual standard advice to practice physical activity as an important measure to promote health benefits.	Other: 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.
Experimental: 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.	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.

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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure	This outcome will be assessed by measuring systolic and diastolic blood pressure in accordance to clinical guidelines and using an automated oscillometric device.	Baseline; 12 weeks; 24 weeks.
Walking capacity	Total distance (in meters) performed during the six-minute walk test.	Baseline; 12 weeks; 24 weeks.
Handgrip strength	Maximum strength (in kgf) achieved by both hands in a handgrip test using a hand dynamometer.	Baseline; 12 weeks; 24 weeks.

Collaborators and Investigators

• Sponsor: Hospital de Clinicas de Porto Alegre
• Collaborators: Federal University of Rio Grande do Sul; Conselho Nacional de Desenvolvimento Científico e Tecnológico
• Investigators: Principal Investigator: Daniel Umpierre, PhD, Hospital de Clínicas de Porto Alegre

Publications and helpful links

Helpful Links

• Study repository - Open Science Framework

Study record dates

Study Major Dates

• Study Start (Anticipated): December 2, 2022
• Primary Completion (Anticipated): December 30, 2025
• Study Completion (Anticipated): December 30, 2025

Study Registration Dates

• First Submitted: April 14, 2022
• First Submitted That Met QC Criteria: April 22, 2022
• First Posted (Actual): April 26, 2022

Study Record Updates

• Last Update Posted (Actual): December 2, 2022
• Last Update Submitted That Met QC Criteria: December 1, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: physical activity; randomized controlled trial; aging; Type 2 diabetes mellitus; pragmatic clinical trial
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 20210394

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No