Diabetes Mellitus, Type 2 Clinical Trial
Official title:
A Socio-ecological Approach to Reduce the Physical Activity Drop-out Ratio in Primary Care-based Patients With Type 2 Diabetes: The SENWI Study Protocol for a Randomized Control Trial.
NCT number | NCT05159089 |
Other study ID # | Uvicucc |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 1, 2022 |
Est. completion date | April 30, 2024 |
Physical activity (PA) - understood as any bodily movement produced by skeletal muscular that requires energy expenditure, related to leisure time, for transport to get to and from places, or part of a person's work - is a powerful force for good regarding type 2 diabetes mellitus (T2DM). However, fewer T2DM patients sustain the lifestyle recommendations suggested by health care professionals (HCP): 40% of patients did not follow-up on general medical recommendations regarding lifestyle changes. Using a socio-ecological approach - that aims to deal with the different levels of PA influences - may be a good solution to integrate the behaviour change techniques in health care professionals' consultations to prescribe PA efficiently. The investigators' protocol has two aims. The primary aim is to evaluate the effectiveness of theory-driven PA intervention based on SEM among people living with T2DM. A secondary aim is to explore the feasibility and perceptions/experiences on the PA adherence process in T2DM patients while using the socio-ecological approach and to understand the HCP's viewpoint in its applicability in the Spanish Healthcare system. The investigators want to know the how, not the what, related to PA prescription.
Status | Recruiting |
Enrollment | 96 |
Est. completion date | April 30, 2024 |
Est. primary completion date | October 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 45 Years to 89 Years |
Eligibility | Inclusion Criteria: 1. Patients with T2D 2. Be eligible to be referred by their doctors for PA intervention; 3. Have no major physical limitations prescribed by the doctor or any HCP 4. Physical inactive according to the General Practice Physical Activity Questionnaire - GPPAQ screening tool. Exclusion Criteria: 1. Pregnant patients or have T2D due to gestation 2. Inability to freely consent to take part in the study 3. Inability to understand the study materials or PA intervention 4. T2D patients with complications as neuropathy, retinopathy, and nephropathy 5. Contraindications to do PA 6. Body Mass Index over 34,9 |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Sant Bernabé | Berga | Barcelona |
Spain | Centre d'Atenció Primaria Anoia | Igualada | Barcelona |
Spain | Centre d'Atenció Primaria les Bases | Manresa | Barcelona |
Spain | Monistrol de Montserrat CAP | Monistrol De Montserrat | Barcelona |
Spain | Centre d'Atenció Primaria Vic Sud | Vic | Barcelona |
Lead Sponsor | Collaborator |
---|---|
University of Vic - Central University of Catalonia |
Spain,
Jabardo-Camprubí G, Donat-Roca R, Sitjà-Rabert M, Milà-Villarroel R, Bort-Roig J. Drop-out ratio between moderate to high-intensity physical exercise treatment by patients with, or at risk of, type 2 diabetes mellitus: A systematic review and meta-analysis. Physiol Behav. 2020 Mar 1;215:112786. doi: 10.1016/j.physbeh.2019.112786. Epub 2019 Dec 18. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Medication patients intake | This outcome will be assessed as a category outcome with three options: i) patients medication intake is reduced or ii) patients medication intake is the same or iii) patients medication intake is increased. | up to 12 weeks | |
Other | Medication patients intake | This outcome will be assessed as a category outcome with three options: i) patients medication intake is reduced or ii) patients medication intake is the same or iii) patients medication intake is increased. | 2 years | |
Primary | Participant physical activity drop-out ratio | During the intervention, drop out will be considered as less than 80% of assistance at schedule sessions.
After the intervention, PA drop out will be measured asking the participants if they continue to undertake PA in their daily life. Participants will be asked once a month until the 24-month (21-month post-intervention) throughout telephone calls and messages (using ecological memorial assessments) about the following-up. What will be important if they do any kind of PA, no matter what kind. The answer will be registered as yes or no. |
up to 12 weeks | |
Primary | Participant physical activity levels | PA levels will be assessed throughout activPAL3™ micro | up to 12 weeks | |
Primary | Participant physical activity levels | PA levels will be assessed throughout activPAL3™ micro | 2 years | |
Primary | Metabolic participants outcomes | HbA1c analysis from blood sample | up to 12 weeks | |
Primary | Metabolic participants outcomes | HbA1c analysis from blood sample | 2 years | |
Secondary | Socioeconomic participant status | Socioeconomic status will be asses using three different levels: occupation, education level and annual income. All three levels will be combined to determine if participants belong to a high, medium or low socioeconomic status. | Before the intervention |
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