Health effects of reduced occupational sedentary behaviour in type 2 diabetes using a mobile health intervention: a study protocol for a 12-month randomized controlled trial-the ROSEBUD study.

Short-term trials conducted in adults with type 2 diabetes mellitus (T2DM) showed that reducing sedentary behaviour by performing regular short bouts of light-intensity physical activity enhances health. Moreover, support for reducing sedentary behaviour may be provided at a low cost via mobile health technology (mHealth). There are a wide range of mHealth solutions available including SMS text message reminders and activity trackers that monitor the physical activity level and notify the user of prolonged sitting periods. The aim of this study is to evaluate the effects of a mHealth intervention on sedentary behaviour and physical activity and the associated changes in health in adults with T2DM. A dual-arm, 12-month, randomized controlled trial (RCT) will be conducted within a nationwide Swedish collaboration for diabetes research in primary health care. Individuals with T2DM (n = 142) and mainly sedentary work will be recruited across primary health care centres in five regions in Sweden. Participants will be randomized (1:1) into two groups. A mHealth intervention group who will receive an activity tracker wristband (Garmin Vivofit4), regular SMS text message reminders, and counselling with a diabetes specialist nurse, or a comparator group who will receive counselling with a diabetes specialist nurse only. The primary outcomes are device-measured total sitting time and total number of steps (activPAL3). The secondary outcomes are fatigue, health-related quality of life and musculoskeletal problems (self-reported questionnaires), number of sick leave days (diaries), diabetes medications (clinical record review) and cardiometabolic biomarkers including waist circumference, mean blood pressure, HbA1c, HDL-cholesterol and triglycerides. Successful interventions to increase physical activity among those with T2DM have been costly and long-term effectiveness remains uncertain. The use of mHealth technologies such as activity trackers and SMS text reminders may increase awareness of prolonged sedentary behaviour and encourage increase in regular physical activity. mHealth may, therefore, provide a valuable and novel tool to improve health outcomes and clinical management in those with T2DM. This 12-month RCT will evaluate longer-term effects of a mHealth intervention suitable for real-world primary health care settings. ClinicalTrials.gov NCT04219800 . Registered on 7 January 2020.

Syrjälä MB ，Bennet L ，Dempsey PC ，Fharm E ，Hellgren M ，Jansson S ，Nilsson S ，Nordendahl M ，Rolandsson O ，Rådholm K ，Ugarph-Morawski A ，Wändell P ，Wennberg P ... -  《Trials》

Effectiveness of a healthcare-based mobile intervention on sedentary patterns, physical activity, mental well-being and clinical and productivity outcomes in office employees with type 2 diabetes: study protocol for a randomized controlled trial.

Prolonged sedentary time is associated with an increased incidence of chronic disease including type 2 diabetes mellitus (DM2). Given that occupational sedentary time contributes significantly to the total amount of daily sedentariness, incorporating programmes to reduce occupational sedentary time in patients with chronic disease would allow for physical, mental and productivity benefits. The aim of this study is to evaluate the short-, medium- and long-term effectiveness of a mHealth programme for sitting less and moving more at work on habitual and occupational sedentary behaviour and physical activity in office staff with DM2. Secondary aims. To evaluate the effectiveness on glycaemic control and lipid profile at 6- and 12-month follow-up; anthropometric profile, blood pressure, mental well-being and work-related post-intervention outcomes at 3, 6 and 12 months. Multicentre randomized controlled trial. A sample size of 220 patients will be randomly allocated into a control (n = 110) or intervention group (n = 110), with post-intervention follow-ups at 6 and 12 months. Health professionals from Spanish Primary Health Care units will randomly invite patients (18-65 years of age) diagnosed with DM2, who have sedentary office desk-based jobs. The control group will receive usual healthcare and information on the health benefits of sitting less and moving more. The intervention group will receive, through a smartphone app and website, strategies and real-time feedback for 13 weeks to change occupational sedentary behaviour. (1) Subjective and objective habitual and occupational sedentary behaviour and physical activity (Workforce Sitting Questionnaire, Brief Physical Activity Assessment Tool, activPAL3TM); 2) Glucose, HbA1c; 3) Weight, height, waist circumference; 4) Total, HDL and LDL cholesterol, triglycerides; (5) Systolic, diastolic blood pressure; (6) Mental well-being (Warwick-Edinburgh Mental Well-being); (7) Presenteeism (Work Limitations Questionnaire); (8) Impact of work on employees´ health, sickness absence (6th European Working Conditions Survey); (9) Job-related mental strain (Job Content Questionnaire). Differences between groups pre- and post- intervention on the average value of the variables will be analysed. If the mHealth intervention is effective in reducing sedentary time and increasing physical activity in office employees with DM2, health professionals would have a low-cost tool for the control of patients with chronic disease. ClinicalTrials.gov NCT04092738. Registered September 17, 2019.

Alòs F ，Colomer MÀ ，Martin-Cantera C ，Solís-Muñoz M ，Bort-Roig J ，Saigi I ，Chirveches-Pérez E ，Solà-Gonfaus M ，Molina-Aragonés JM ，Puig-Ribera A ... -  《-》

Reducing occupational sitting time in adults with type 2 diabetes: Qualitative experiences of an office-adapted mHealth intervention.

Understanding barriers and facilitators for limiting occupational sitting and what impact it has on health on those with type 2 diabetes is essential for future trials and intervention development in primary healthcare settings. This study aimed to explore the feasibility and acceptability of an intervention using mobile health (mHealth) technology, together with counselling by a diabetes specialist nurse, to reduce occupational sitting in adults with type 2 diabetes. Individual semi-structured interviews were conducted in 15 participants with type 2 diabetes who completed a 3-month intervention including mHealth; activity tracker (Garmin Vivofit3) and SMS reminders, one initial face-to-face patient-centred counselling session and three telephone follow-up calls by a diabetes specialist nurse within the primary healthcare system in Sweden. The interviews were recorded, transcribed verbatim and analysed using qualitative content analysis. Two themes were identified: (1) 'From baby steps to milestones' reflecting three categories; 'Small changes make it easier to reduce sitting', 'Encouraged by trustworthy coaching', 'Physical and mental rewards matter' and (2) 'Tailoring strategies that fit me and my workplace' reflecting four categories; 'It's up to me', 'Taking advantage of the support', 'Using creativity to find practical solutions for interrupting sitting' and 'Living up to expectations'. The intervention was perceived as feasible and acceptable in different office workplaces, and led to increased awareness of sedentary behaviour in adults with type 2 diabetes. Stepwise goal setting together with personalization of the mHealth intervention should be emphasized in individual type 2 diabetes programmes aiming to reduce workplace sitting.

Syrjälä MB ，Fharm E ，Dempsey PC ，Nordendahl M ，Wennberg P ... -  《-》

Efficacy of a Self-Regulation-Based Electronic and Mobile Health Intervention Targeting an Active Lifestyle in Adults Having Type 2 Diabetes and in Adults Aged 50 Years or Older: Two Randomized Controlled Trials.

Adopting an active lifestyle plays a key role in the prevention and management of chronic diseases such as type 2 diabetes mellitus (T2DM). Web-based interventions are able to alter health behaviors and show stronger effects when they are informed by a behavior change theory. MyPlan 2.0 is a fully automated electronic health (eHealth) and mobile health (mHealth) intervention targeting physical activity (PA) and sedentary behavior (SB) based on the Health Action Process Approach (HAPA). This study aimed to test the short-term effect of MyPlan 2.0 in altering levels of PA and SB and in changing personal determinants of behavior in adults with T2DM and in adults aged ≥50 years. The study comprised two randomized controlled trials (RCTs) with an identical design. RCT 1 was conducted with adults with T2DM. RCT 2 was performed in adults aged ≥50 years. Data were collected via face-to-face assessments. The participants decided either to increase their level of PA or to decrease their level of SB. The participants were randomly allocated with a 2:1 ratio to the intervention group or the waiting-list control group. They were not blinded for their group allocation. The participants in the intervention group were instructed to go through MyPlan 2.0, comprising 5 sessions with an interval of 1 week between each session. The primary outcomes were objectively measured and self-reported PA (ie, light PA, moderate-to-vigorous PA, total PA, number of steps, and domain-specific [eg, transport-related] PA) and SB (ie, sitting time, number of breaks from sitting time, and length of sitting bouts). Secondary outcomes were self-reported behavioral determinants for PA and SB (eg, self-efficacy). Separate linear mixed models were performed to analyze the effects of MyPlan 2.0 in the two samples. In RCT 1 (n=54), the PA intervention group showed, in contrast to the control group, a decrease in self-reported time spent sitting (P=.09) and an increase in accelerometer-measured moderate (P=.05) and moderate-to-vigorous PA (P=.049). The SB intervention group displayed an increase in accelerometer-assessed breaks from sedentary time in comparison with the control group (P=.005). A total of 14 participants of RCT 1 dropped out. In RCT 2 (n=63), the PA intervention group showed an increase for self-reported total PA in comparison with the control group (P=.003). Furthermore, in contrast to the control group, the SB intervention group decreased their self-reported time spent sitting (P=.08) and increased their accelerometer-assessed moderate (P=.06) and moderate-to-vigorous PA (P=.07). A total of 8 participants of RCT 2 dropped out. For both the samples, the HAPA-based eHealth and mHealth intervention, MyPlan 2.0, was able to improve only some of the primary outcomes. ClinicalTrials.gov NCT03291171; http://clinicaltrials.gov/ct2/show/NCT03291171. ClinicalTrials.gov NCT03799146; http://clinicaltrials.gov/ct2/show/NCT03799146. RR2-10.2196/12413.

Poppe L ，De Bourdeaudhuij I ，Verloigne M ，Shadid S ，Van Cauwenberg J ，Compernolle S ，Crombez G ... -  《JOURNAL OF MEDICAL INTERNET RESEARCH》

mHealth intervention delivered in general practice to increase physical activity and reduce sedentary behaviour of patients with prediabetes and type 2 diabetes (ENERGISED): rationale and study protocol for a pragmatic randomised controlled trial.

The growing number of patients with type 2 diabetes and prediabetes is a major public health concern. Physical activity is a cornerstone of diabetes management and may prevent its onset in prediabetes patients. Despite this, many patients with (pre)diabetes remain physically inactive. Primary care physicians are well-situated to deliver interventions to increase their patients' physical activity levels. However, effective and sustainable physical activity interventions for (pre)diabetes patients that can be translated into routine primary care are lacking. We describe the rationale and protocol for a 12-month pragmatic, multicentre, randomised, controlled trial assessing the effectiveness of an mHealth intervention delivered in general practice to increase physical activity and reduce sedentary behaviour of patients with prediabetes and type 2 diabetes (ENERGISED). Twenty-one general practices will recruit 340 patients with (pre)diabetes during routine health check-ups. Patients allocated to the active control arm will receive a Fitbit activity tracker to self-monitor their daily steps and try to achieve the recommended step goal. Patients allocated to the intervention arm will additionally receive the mHealth intervention, including the delivery of several text messages per week, with some of them delivered just in time, based on data continuously collected by the Fitbit tracker. The trial consists of two phases, each lasting six months: the lead-in phase, when the mHealth intervention will be supported with human phone counselling, and the maintenance phase, when the intervention will be fully automated. The primary outcome, average ambulatory activity (steps/day) measured by a wrist-worn accelerometer, will be assessed at the end of the maintenance phase at 12 months. The trial has several strengths, such as the choice of active control to isolate the net effect of the intervention beyond simple self-monitoring with an activity tracker, broad eligibility criteria allowing for the inclusion of patients without a smartphone, procedures to minimise selection bias, and involvement of a relatively large number of general practices. These design choices contribute to the trial's pragmatic character and ensure that the intervention, if effective, can be translated into routine primary care practice, allowing important public health benefits. ClinicalTrials.gov (NCT05351359, 28/04/2022).

Vetrovsky T ，Kral N ，Pfeiferova M ，Kuhnova J ，Novak J ，Wahlich C ，Jaklova A ，Jurkova K ，Janek M ，Omcirk D ，Capek V ，Maes I ，Steffl M ，Ussher M ，Tufano JJ ，Elavsky S ，Van Dyck D ，Cimler R ，Yates T ，Harris T ，Seifert B ... -  《-》