Physical Activity Drop-out Ratio in Patients Living With Type 2 Diabetes

NCT05159089 | Unknown

• 1 other identifier: Uvicucc
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Diabetes Mellitus, Type 2; Adherence, Patient; Physical Inactivity

Outcome Measures

Primary Outcomes (5)

• 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

• Participant physical activity levels

  PA levels will be assessed throughout activPAL3™ micro

  up to 12 weeks

• Participant physical activity levels

  PA levels will be assessed throughout activPAL3™ micro

  2 years

• Metabolic participants outcomes

  HbA1c analysis from blood sample

  up to 12 weeks

• Metabolic participants outcomes

  HbA1c analysis from blood sample

  2 years

Secondary Outcomes (1)

• Socioeconomic participant status

  Before the intervention

Other Outcomes (2)

• Medication patients intake

  up to 12 weeks

• Medication patients intake

  2 years

Study Arms (3)

Nordic Walking Group

ACTIVE COMPARATOR

Each group will be received 26 sessions of nordic walking. In each session, the intensity will be controlled and expected to be between 3 to 5 in the Borg scale adaptation. Patients will receive a schedule with all three-month sessions.

Behavioral: Nordic Walking

Physical activity base on SEM (Socioecological models)

EXPERIMENTAL

The intervention group based on SEM will apply nordic walking in the same way as the Nordic Walking group. However, in this group, instructors will apply a SEM (instructors will not be the same as in the Nordic Walking group): in each session, the instructors in charge of the Nordic Walking will be also in charge to prescribe the PA.

Behavioral: Socioecological model apply to reduce physical activity drop out in type 2 diabetes patients

Congrol group

NO INTERVENTION

Control group outcomes assessment will be the same as the intervention group. However, they will receive common health care professional advice. A common health care professional advice used to recommend patients to walk more and do more PA or physical exercise at the gym. Visits with doctors and nurses will be the same as the intervention group. The difference will be that at intervention group nurses will refer participants to the instructor's physiotherapist to promote PA throughout nordic walking and use the SEM to apply it.

Interventions

Socioecological model apply to reduce physical activity drop out in type 2 diabetes patients BEHAVIORAL

To implement this model this intervention aims to address three key elements: 1) prepare the user; 2) structure the action; and 3) design the context. These goals will be worked in each session of Nordic Walking during the warm-up and cool-down and, if necessary, during the session (as long as it's non-stop or slowing down).

Physical activity base on SEM (Socioecological models)

Nordic Walking BEHAVIORAL

Sessions will be progressive: the first month will long 30 minutes, the second month 35 minutes, and the third month 40 minutes (without 10 minutes warm-up and 10 minutes cool-down each session). The track will not have more than 100 accumulate high and will allow doing 5 kilometers without stopping. The meeting point will be between the Biomedical Research Park (Barcelona) and Hospital del Mar (nearby CAP Sant Joan). All sessions will be conducted by an instructor of nordic walking physiotherapists.

Nordic Walking Group

Eligibility Criteria

• Age: 45 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with T2D
• Be eligible to be referred by their doctors for PA intervention;
• Have no major physical limitations prescribed by the doctor or any HCP
• Physical inactive according to the General Practice Physical Activity Questionnaire - GPPAQ screening tool.

You may not qualify if:

• Pregnant patients or have T2D due to gestation
• Inability to freely consent to take part in the study
• Inability to understand the study materials or PA intervention
• T2D patients with complications as neuropathy, retinopathy, and nephropathy
• Contraindications to do PA
• Body Mass Index over 34,9

Sponsors & Collaborators

• University of Vic - Central University of Catalonia: lead

Study Sites (5)

Hospital Sant Bernabé

Berga, Barcelona, 08600, Spain

NOT YET RECRUITING

Centre d'Atenció Primaria Anoia

Igualada, Barcelona, 08700, Spain

NOT YET RECRUITING

Centre d'Atenció Primaria les Bases

Manresa, Barcelona, 08241, Spain

NOT YET RECRUITING

Monistrol de Montserrat CAP

Monistrol de Montserrat, Barcelona, 08691, Spain

RECRUITING

Centre d'Atenció Primaria Vic Sud

Vic, Barcelona, 08500, Spain

NOT YET RECRUITING

Related Publications (2)

• Jabardo-Camprubi G, Donat-Roca R, Sitja-Rabert M, Mila-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.

  PMID: 31863856 BACKGROUND

• Jabardo-Camprubi G, Bort-Roig J, Donat-Roca R, Mila-Villarroel R, Sitja-Rabert M, McKenna J, Puig-Ribera A. 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. Trials. 2022 Oct 3;23(1):842. doi: 10.1186/s13063-022-06742-7.

  PMID: 36192800 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Patient Compliance; Sedentary Behavior

Interventions

Nordic Walking

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Walking; Locomotion; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise; Motor Activity

Study Officials

• Guillem Jabardo-Camprubí

  University of Vic - Central University of Catalonia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guillem Jabardo-Camprubí

CONTACT

691145828; guillem.jabardo@uvic.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The trial has an open design with a blind assessment of outcomes. Researchers conduction the baseline assessments will be blind to group allocation. The statistician (RMV) will also be blind to group allocation until the completion of the statistical analysis. Participants will be asked not to reveal group allocation when undergoing follow-up measurements. To assess the extent to which blinding has been preserved, researchers will record the number of cases in which allocation was revealed.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A mixed methods research model will be used. A prospective and longitudinal three-arm randomized control trial with blinded evaluators will be needed to compare the efficacy of the interventions. Outcomes will be assessed at baseline, month three (end of intervention), and at months 12 and 24 (9 and 21-month post-intervention), which will be the main outcome assessment. The study protocol has been developed based on the Standard Protocol Items: Recommendation for Interventional Trials (SPIRIT) guidelines. On the other hand, a qualitative analysis using semi-structural interviews should help to understand both the reasons for the (un)efficacy and the patients' and HCP's perceptions about the intervention. Qualitative outcomes will be assessed at month three (end of intervention) and at month 24 (21-month post-intervention).

Study Record Dates

• First Submitted: November 2, 2021
• First Posted: December 15, 2021
• Study Start: May 1, 2022
• Primary Completion: October 30, 2022
• Study Completion: April 30, 2024
• Last Updated: June 16, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (5)