BACKGROUND: The distribution of time across physical activity, sedentary behaviors, and sleep appears to be essential for the management of obesity. However, the impact of reallocating time among these behaviors, collectively known as 24-h movement behaviors, remains underexplored. OBJECTIVE: This study examines the theoretical effects of reallocating time between 24-h movement behaviors on obesity indicators across different age groups. METHODS: We performed a pooled data meta-analysis of 9818 participants from 11 observational and experimental studies. To estimate the time spent in movement behaviors, we reprocessed and harmonized individual-level raw accelerometer-derived data. Isotemporal substitution models estimated theoretical changes in body mass index (BMI) and waist circumference (WC) associated with time reallocation between movement behaviors. We performed the analysis separately for children, adolescents, adults, and older adults. RESULTS: Even minor reallocations of 10 min led to significant changes in obesity indicators, with pronounced effects observed when 30 min were reallocated. The most substantial adverse effects on BMI and WC occurred when moderate-to-vigorous physical activity (MVPA) was reallocated to other movement behaviors. For 30-min reallocations, the largest increase in BMI (or BMI z-score for children) occurred when MVPA was reallocated to light-intensity physical activity (LPA) in children (0.26 units, 95% confidence interval [CI] 0.15, 0.37) and to sedentary behavior (SB) in adults (0.72 kg/m2, 95% CI 0.47, 0.96) and older adults (0.73 kg/m2, 95% CI 0.59, 0.87). The largest increase in WC was observed when MVPA was substituted with LPA in adults (2.66 cm, 95% CI 1.42, 3.90) and with SB in older adults (2.43 cm, 95% CI 2.07, 2.79). Conversely, the highest magnitude of the decrease in obesity indicators was observed when SB was substituted with MVPA. Specifically, substituting 30 min of SB with MVPA was associated with a decrease in BMI z-score by - 0.15 units (95% CI - 0.21, - 0.10) in children and lower BMI by - 0.56 kg/m2 (95% CI - 0.74, - 0.39) in adults and by - 0.52 kg/m2 (95% CI - 0.61, - 0.43) in older adults. Reallocating time away from sleep and LPA showed several significant changes but lacked a consistent pattern. While the predicted changes in obesity indicators were generally consistent across age groups, inconsistent findings were observed in adolescents, particularly for reallocations between MVPA and other behaviors. CONCLUSIONS: This investigation emphasizes the crucial role of MVPA in mitigating obesity risk across the lifespan, and the benefit of substituting SB with low-intensity movement behaviors. The distinct patterns observed in adolescents suggest a need for age-specific lifestyle interventions to effectively address obesity. Emphasizing manageable shifts, such as 10-min reallocations, could have significant public health implications, promoting sustainable lifestyle changes that accommodate individuals with diverse needs, including those with severe obesity.

• MeSH
• Accelerometry MeSH
• Time Factors MeSH
• Exercise * MeSH
• Child MeSH
• Adult MeSH
• Body Mass Index MeSH
• Obesity Management * methods   MeSH
• Middle Aged MeSH
• Humans MeSH
• Adolescent MeSH
• Young Adult MeSH
• Obesity * MeSH
• Waist Circumference MeSH
• Sedentary Behavior * MeSH
• Aged MeSH
• Sleep MeSH
• Check Tag
• Child MeSH
• Adult MeSH
• Middle Aged MeSH
• Humans MeSH
• Adolescent MeSH
• Young Adult MeSH
• Male MeSH
• Aged MeSH
• Publication type
• Journal Article MeSH
• Meta-Analysis MeSH

Úvod: Počty císařských řezů (CS – cesarean section) celosvětově rostou, přičemž související poporodní komplikace jsou výrazně vyšší ve srovnání s vaginálním porodem. Řešení těchto komplikací pomocí optimalizovaného managementu a cílené fyzioterapie je klíčové pro zlepšení mateřských výsledků a kvality života. Cíl: Cílem této studie bylo zhodnotit účinnost fyzioterapie na úlevu od bolesti a obnovení funkční aktivity žen po CS. Materiál a metody: Do studie bylo zapojeno 91 pacientek, které byly přijaty do porodnické nemocnice pro elektivní CS. Kontrolní skupině (47 žen) byl poskytnut standardní předoperační a pooperační dohled. Intervenční skupina (44 pacientů) kromě standardní péče absolvovala fyzioterapii, která zahrnovala předoperační péči (fyzioterapeutický výcvik, edukační výcvik) a pooperační cvičení (dechové, oběhové a pánevní cvičení spolu s masáží pojiva). Výsledky po CS byly analyzovány po dobu 3 dnů. Výsledky: Nižší intenzita pooperačních bolestí a snazší chůze od 1. dne, nižší obtížnost při provádění funkčních činností 2. den (snazší otočení na lůžku a přechod do sedu), rychlejší obnova střevní motility v důsledku průchodu flatusu za 3,5 hod a defekace na 10 hod, snížená potřeba analgetik navíc 4,21krát (OR = 0,24; 95% CI 0,10–0,58; p = 0,02) a bylo zjištěno významné snížení doby trvání hospitalizace (OR = 0,24; 95% CI 0,09–0,57; p = 0,02). Závěr: Studie prokázala účinnost navrženého fyzioterapeutického programu v časném období po CS ve smyslu snížení bolesti a zlepšení obnovy funkční aktivity organizmu.

Background: Cesarean section (CS) rates are rising globally, with associated postpartum complications significantly higher compared to vaginal delivery. Addressing these complications through optimized management and targeted physiotherapy is crucial for improving maternal outcomes and quality of life. Objective: This study aimed to evaluate the effectiveness of physiotherapy on pain relief and restoration of functional activity in women after CS. Material and methods: 91 patients, who were admitted to an obstetric hospital for elective CS, were involved in the study. The control group (47 women) received standard pre- and postoperative supervision. The intervention group (44 patients), in addition to standard care, underwent physiotherapy, which included preoperative care (physiotherapy training, educational training), and postoperative exercises (breathing, circulation, and pelvic exercises, along with connective tissue massage). The results were analyzed after CS for 3 days. Results: A lower intensity of postoperative pain and easier walking from the 1st day, a lower level of difficulty in performing functional activities on the 2nd day (easier turning in bed and transition to a sitting position), faster recovery of intestinal motility due to the passage of flatus in 3.5 hours and the act of defecation after 10.0 hours, decreased requirement of extra analgesics by 4.21-fold (OR = 0.24; 95% CI 0.10–0.58; P = 0.02), and a significant reduction in the length of hospital stay (OR = 0.24; 95% CI 0.09–0.57; P = 0.02) were established. Conclusion: The study revealed the effectiveness of the proposed physiotherapy program in the early post-cesarean period in terms of reducing pain and improving restoration of the body’s functional activity.

BACKGROUND: Adolescents' movement behaviours (MB) vary between schooldays and weekends, potentially impacting health-related quality of life (HRQoL) and well-being. This study aimed to identify transitions between 24-h MB profiles on schooldays and weekends and examine their associations with HRQoL and well-being. METHODS: This is a cross-sectional study of 1070 Czech adolescents (average age: 13.8 years and standard deviation: 2.2 years; 56% girls). Participants wore accelerometers for 7 consecutive days to assess physical activity (PA) of different intensities, sedentary behaviour (SB) and sleep. A subsample of 451 participants provided data on HRQoL, which was measured using the Paediatric Quality of Life Inventory, and 484 provided valid well-being data measured with the 5-item World Health Organisation Well-Being Index. Latent transition analysis was used on the MB variables to identify transitions across MB profiles, and linear regression was used to examine associations between transitions and HRQoL or well-being. RESULTS: Four MB profiles were identified: Excellent (high PA, low SB and high sleep duration), Good (average MB values), Fair (below-average PA and sleep, above-average SB) and Poor (low PA and sleep, high SB). Most adolescents transitioned to less favourable profiles on weekends. Those remaining in the Excellent profile had higher HRQoL than those transitioning to less favourable profiles. Transitions to the Poor profile were associated with the lowest HRQoL and well-being scores. CONCLUSION: This study underscores the dynamic nature of adolescents' MB and the importance of consistent, healthy routines. Interventions optimizing 24-h MB throughout the week and especially on weekends may enhance adolescent HRQoL and well-being, but further evidence from longitudinal and intervention studies is needed. SUMMARY: We observed a contrast in 24-h MB between schooldays and weekends: 29.7% of adolescents were in the Excellent on schooldays, but only 5.8% did so on weekends, while the prevalence of the Poor profile rose from 1.6% on schooldays to 27.7% on weekends. Adolescents who maintained the Excellent profile across the whole week recorded the highest scores for HRQoL and well-being. Moving into the Poor profile on weekend was associated with about 9 points poorer HRQoL and 14 points lower well-being, compared with peers who remained in the Excellent profile. Behaviour change strategies should target the entire week to preserve PA, reduce SB and protect sleep.

• MeSH
• Accelerometry MeSH
• Time Factors MeSH
• Adolescent Behavior * psychology   physiology   MeSH
• Exercise * psychology   physiology   MeSH
• Quality of Life * psychology   MeSH
• Humans MeSH
• Adolescent MeSH
• Cross-Sectional Studies MeSH
• Sedentary Behavior MeSH
• Sleep physiology   MeSH
• Check Tag
• Humans MeSH
• Adolescent MeSH
• Male MeSH
• Female MeSH
• Publication type
• Journal Article MeSH
• Geographicals
• Czech Republic MeSH

BACKGROUND: Preservation of mobility independence is a primary goal in older adults with physical frailty and sarcopenia (PF&S). Interventions based on the combination of physical activity (PA) and nutritional counselling have been indicated as strategies for the management of this condition, although their effectiveness is not confirmed in all investigations. A possible explanation for this uncertain scenario relies in the impact of the adherence to PA interventions. Hence, the present study investigated the impact of the adherence to PA sessions on the incidence of mobility disability in older adults with PF&S. METHODS: This is a secondary analysis of an evaluator blinded, randomised controlled trial, developed in 16 clinical sites across 11 European countries, from January 2016 to 31 October 2019. Participants were community-dwelling older adults (70+ years) with PF&S enrolled in the SPRINTT trial (NCT02582138). PF&S was operationalised as having a total score from 3 to 9 on the short physical performance battery (SPPB), low appendicular lean mass and ability to complete the 400-m walk test in < 15 min. Data from participants allocated to a multicomponent intervention (PA with technological support plus nutritional counselling) and a healthy ageing lifestyle education programme (control group) were analysed. Adherence to PA was assessed based on the number of weekly sessions attended. According to recommendations of the American College of Sports Medicine, adherence was categorised as below recommendations (< 2 sessions/week, BR), meeting recommendations (2-3 sessions/week, MR), and above recommendations (> 3 sessions/week, AR). The primary outcome was incident mobility disability, operationalised as incident inability to complete the 400-m walk test in < 15 min during up to 36 months of follow-up. RESULTS: Data of 1444 participants (mean age 79.3 years, 72.6% women) were analysed. In those with SPPB scores of 3-7, MR and AR groups had lower risk of mobility disability compared with controls [MR HR (95% CI): 0.57 (0.41-0.78), p = 0.001; AR HR (95% CI): 0.33 (0.23-0.46), p < 0.001] and BR groups [MR: HR (95% CI): 0.48 (0.34-0.69), p < 0.001; AR: HR (95% CI): 0.27 (0.18-0.38), p < 0.001] in a dose-dependent manner. In those with SPPB scores of 8 or 9, the BR group had a higher risk of mobility disability than controls. MR and AR groups had a lower risk of mobility disability than the BR group. CONCLUSIONS: In older adults with PF&S, adherence to PA recommendations is associated with lower incidence of mobility disability. This benefit depends on the degree of adherence as well as baseline physical performance. TRIAL REGISTRATION: ClinicalTrials.gov NCT02582138.

• MeSH
• Exercise * physiology   MeSH
• Humans MeSH
• Mobility Limitation * MeSH
• Persons with Disabilities MeSH
• Sarcopenia * physiopathology   therapy   MeSH
• Aged, 80 and over MeSH
• Aged MeSH
• Check Tag
• Humans MeSH
• Male MeSH
• Aged, 80 and over MeSH
• Aged MeSH
• Female MeSH
• Publication type
• Journal Article MeSH
• Multicenter Study MeSH
• Randomized Controlled Trial MeSH

Promoting healthy aging through physical activity (PA) is crucial as the global population grows older. Traditional interventions often fail to engage older adults, underlining the need for personalized, timely approaches. Smartphone-delivered PA interventions can offer personalized support during opportune moments for behavioral change. The current study examined whether the receptivity of inactive older adults influences compliance with mHealth walking suggestions after inactivity, and explored their experiences with it. Thirty healthy older adults (mean age 73.9 years) participated in the study and answered event-based EMA questionnaires via HealthReact after each 30-minute inactivity period. Emotions, physical complaints, intention, self-efficacy, perceived walking, and environmental permissiveness were assessed. Walking suggestions followed each EMA, and semi-structured interviews were conducted post-study. Multilevel logistic regressions in R were applied, and qualitative data were thematically analyzed using NVivo. Results show that higher intention, self-efficacy, and environmental permissiveness positively correlated with compliance, while higher perceived walking negatively correlated. Participants generally found the suggestions motivating and well-timed, but some reported increased alertness and pressure. Consequently, tailoring interventions to individual needs and targeting receptive moments can enhance compliance and promote healthier aging through increased PA. Future mobile interventions should consider self-efficacy, intention, prior activity, and environmental conditions to improve effectiveness.

• MeSH
• Patient Compliance * psychology   MeSH
• Walking * psychology   MeSH
• Smartphone MeSH
• Exercise psychology   MeSH
• Middle Aged MeSH
• Humans MeSH
• Longitudinal Studies MeSH
• Health Promotion * methods   MeSH
• Self Efficacy MeSH
• Aged, 80 and over MeSH
• Aged MeSH
• Telemedicine MeSH
• Intention MeSH
• Healthy Aging * psychology   MeSH
• Check Tag
• Middle Aged MeSH
• Humans MeSH
• Male MeSH
• Aged, 80 and over MeSH
• Aged MeSH
• Female MeSH
• Publication type
• Journal Article MeSH

Celosvetovo patrí obezita k najrozšírenejším chronickým ochoreniam ako v dospelej, tak aj v detskej a adolescentnej populácii. V súčasnosti je jedným z najvýznamnejších problémov verejného zdravia nielen kvôli narastajúcej prevalencii, ale najmä asociácii so širokým spektrom ďalších chronických a život ohrozujúcich ochorení. Na Slovensku sa prevalencia nadhmotnosti pohybuje v rozmedzí okolo 63 %, prevalencia obezity okolo 29 %. V júni 2024 v Nature Medicine publikovala a zaviedla Európska spoločnosť pre štúdium obezity (European Association for the Study of Obesity – EASO) rámec na zosúladenie diagnostiky, hodnotenia závažnosti a liečby obezity so štandardmi iných chronických ochorení. Ciele liečby chronického ochorenia – (pre)obezity by mali byť holistické, mali by ísť „za“ pokles hmotnosti v kilogramoch, čo prináša so sebou dlhodobé prínosy pre zdravie, duševnú pohodu, fyzické fungovanie a zlepšenie kvality života. Holistické ciele môžeme dosiahnuť zmenou životného štýlu (behaviorálne, nutričné a pohybové intervencie). Zhodnotenie závažnosti ochorenia ovplyvňuje individuálnu liečbu (personalizovaná medicína) a v súčasnosti máme možnosť využívať kombináciu zmeny životného štýlu s farmakoterapiou, prípadne aj bariatrickými chirurgickými postupmi. V ostatnom čase nám pribudlo veľa nových informácií, výsledkov zo zaujímavých klinických štúdií týkajúcich sa farmakologického manažmentu založeného na báze inkretínov. V blízkej budúcnosti sa dočkáme aj ďalších noviniek zacielených na chronický manažment obezity.

Worldwide, obesity is one of the most widespread chronic diseases in the adult, child and adolescent population. It is currently one of the most significant public health problems not only due to its increasing prevalence, but especially due to its association with a wide range of other chronic and life-threatening diseases. In Slovakia, the prevalence of overweight is around 63 %, and the prevalence of obesity is around 29 %. In June 2024, the European Association for the Study of Obesity (EASO) published and introduced a framework to align the diagnosis, assessment of severity and treatment of obesity with the standards of other chronic diseases. The goals of treatment of chronic disease – (pre)obesity should be holistic, they should go “beyond” weight loss in kilograms, which brings with it long-term benefits for health, mental well-being, physical functioning and improved quality of life. Holistic goals can be achieved by changing lifestyle (behavioral, nutritional and exercise interventions). The assessment of the severity of the disease influences individual treatment (personalized medicine) and currently we have the opportunity to use a combination of lifestyle changes with pharmacotherapy, or even bariatric surgical procedures. Recently, we have received a lot of new information, results from interesting clinical studies related to pharmacological management based on incretins. In the near future we will also see other news aimed at chronic management of obesity.

• MeSH
• Glucagon-Like Peptide-1 Receptor Agonists pharmacology   therapeutic use   MeSH
• Anti-Obesity Agents pharmacology   therapeutic use   MeSH
• Obesity Management methods   MeSH
• Humans MeSH
• Obesity * drug therapy   MeSH
• Tirzepatide pharmacology   therapeutic use   MeSH
• Check Tag
• Humans MeSH
• Publication type
• Review MeSH

Obezita a diabetes mellitus 2. typu (DM2T) sú významnými rizikovými faktormi rozvoja kognitívnej dysfunkcie a neurodegeneratívnych ochorení. Ich spoločný patofyziologický základ zahŕňa inzulínovú rezistenciu, chronický subklinický systémový zápal a neurozápal, poruchy mikrobiómu, hormonálnu dysreguláciu a štrukturálne zmeny mozgu. Tieto faktory vedú k zhoršeniu pamäte, exekutívnych funkcií a k akcelerácii neurodegenerácie. Pozitívne účinky úpravy životného štýlu – vrátane zníženia telesnej hmotnosti, zvýšenia fyzickej aktivity a úpravy výživy a stravovacích návykov – sa prejavujú zlepšením inzulínovej senzitivity v mozgu, zvýšením neurotrofických faktorov, redukciou systémového zápalu a neurozápalu a zlepšením metabolizmu. Kombinácia behaviorálnych a farmakologických intervencií môže spomaliť kognitívny pokles a znížiť riziko demencie u populácie s obezitou a poruchou metabolizmu glukózy.

Obesity and type 2 diabetes (T2D) are important risk factors for the development of cognitive dysfunction and neurodegenerative diseases. Their common pathophysiological substrate includes insulin resistance, chronic subclinical systemic inflammation, neuroinflammation, shifts in the intestinal microbiome composition, hormonal dysregulation, and structural changes of the brain. These factors lead to impaired memory, executive functions, and accelerated neurodegeneration. The positive effects of lifestyle modifications — including weight loss, increased physical activity, and improved dietary composition — are manifested by improved insulin sensitivity in the brain, increased neurotrophic factors, reduced systemic inflammation and neuroinflammation, and improved metabolism. A combination of behavioral and pharmacological interventions may slow cognitive decline and reduce the risk of dementia in patients with obesity, prediabetes and T2D.

• MeSH
• Exercise MeSH
• Diabetes Mellitus, Type 2 complications   MeSH
• Weight Loss MeSH
• Cognition Disorders * etiology   MeSH
• Humans MeSH
• Neurodegenerative Diseases etiology   MeSH
• Obesity * complications   MeSH
• Check Tag
• Humans MeSH
• Publication type
• Review MeSH

Improving the quality of the most basic health behavior among youth may contribute to short-term body composition management with long-term implications for noncommunicable disease regression. This investigation aimed to assess the impact of primary school physical activity (PA), dietary, or dual approach interventions on pupils' body weight (BW) and body mass index (BMI). A systematic review and meta-analysis was completed following a study protocol and a trial registration (PROSPERO: CRD4202347770) with the PRISMA approach. Publications in English or German were included with school-based randomized controlled trials on diet and/or PA. Pupils of primary schools (aged 5-10) with no major nutritional deficiency or unstable health condition were included. The Boolean search strategy revealed a total of 9479 articles, qualifying 39 studies with 20 462 pupils (including 10 211 girls and 10 251 boys) for quantitative synthesis. The interventions were mostly PA (n = 31), several were dietary (n = 6), and some were dual approach (n = 5). Random effects meta-analyses revealed PA intervention (n = 20) to have an effect size of +0.07 kg (95% CI: -0.01 to 0.15) and -0.12 kg/m2 (95% CI: -0.23 to -0.01). Low statistical heterogeneity was found for BW (I2 = 0%; P = 1.000) and BMI (I2 = 0%; P = .9688), respectively. The findings indicate a scarcity of top-quality scientific research performed on healthy diet for body weight management in primary schools. PA intervention for elementary school pupils provides support for a healthier body composition profile amidst the current world health crisis.

• MeSH
• Exercise * MeSH
• Diet * MeSH
• Child MeSH
• Body Mass Index MeSH
• Humans MeSH
• Health Promotion * methods   MeSH
• Child, Preschool MeSH
• Randomized Controlled Trials as Topic MeSH
• School Health Services MeSH
• Schools MeSH
• Students * statistics & numerical data   MeSH
• Body Weight * MeSH
• Public Health * MeSH
• Check Tag
• Child MeSH
• Humans MeSH
• Male MeSH
• Child, Preschool MeSH
• Female MeSH
• Publication type
• Journal Article MeSH
• Meta-Analysis MeSH
• Systematic Review MeSH

Cíl: Přehled možností využití nelékařského zdravotnického oboru ergoterapie v onkogynekologii, popis role ergoterapeuta v prehabilitaci, zhodnocení dat z pilotní studie. Soubor a metodika: Do studie probíhající od listopadu 2023 do října 2024 bylo zařazeno celkem 18 pacientek, prospektivní studie probíhala po dobu 9 měsíců. Jednalo se o pacientky přijaté k 3týdenní intenzivní multimodální prehabilitaci v režimu 4/7 před plánovaným operačním výkonem pro primární nebo recidivující maligní nádor ovaria, endometria nebo děložního hrdla. Pacientkám se v rámci prehabilitace věnoval kromě lékařů i fyzioterapeut, psycholog, nutriční specialista a ergoterapeut. Klinická práce ergoterapeuta byla změřena na vyšetření a následnou terapii v oblasti kognitivních funkcí, jemné motoriky horních končetin, soběstačnosti a kvality života. Ergoterapeut aplikoval vybrané funkční testy a dotazníky (MKF klasifikace, Hand grip test, MoCA test, 5× Sit-to-Stand test, WHODAS 2.0) pro zjištění efektu rehabilitační intervence. Výsledky a závěry: Důležitými sledovanými ukazateli byly vybrané funkční schopnosti, které mají významný dopad na kvalitu života pacientek. Výsledky funkčních testů prokázaly významné zlepšení klíčových parametrů vlivem intenzivní prehabilitace, což potvrzuje zásadní roli intervence ergoterapeuta v onkogynekologické prehabilitaci.

Objective: Overview of the possibilities of using non-medical occupational therapy in oncogynecology, description of the role of an occupational therapist in prehabilitation, and evaluation of data from a pilot study. Methods: The study cohort consisted of 18 patients enrolled between November 2023 and October 2024. The prospective study was conducted over a period of nine months. Patients were admitted for a 3-week intensive multimodal prehabilitation program scheduled on a 4/7 basis prior to elective surgery for primary or recurrent malignant ovarian, endometrial, or cervical cancer. In addition to the physicians, patients received prehabilitation by a physiotherapist, psychologist, nutritionist, and occupational therapist. Clinical work of the occupational therapist was measured upon examination and subsequent therapy in the areas of cognitive function, fine motor skills of the upper limbs, self-sufficiency, and quality of life. The occupational therapist applied selected functional tests and questionnaires (MKF classification, Hand grip test, MoCA test, 5× Sit-to-Stand test, WHODAS 2.0) to determine the effect of the rehabilitation intervention. Results and conclusions: Important indicators were selected functional abilities that have a significant impact on the quality of life of patients. The results of functional tests showed a significant improvement of key parameters due to intensive prehabilitation, confirming the essential role of occupational therapist intervention in oncogynecological prehabilitation.

• MeSH
• Occupational Therapy * methods   statistics & numerical data   MeSH
• Preoperative Exercise MeSH
• Patient Reported Outcome Measures MeSH
• Quality of Life MeSH
• Humans MeSH
• Genital Neoplasms, Female * rehabilitation   MeSH
• Pilot Projects MeSH
• Prospective Studies MeSH
• Surveys and Questionnaires MeSH
• Check Tag
• Humans MeSH
• Female MeSH
• Publication type
• Research Support, Non-U.S. Gov't MeSH

BACKGROUND: Type 2 diabetes and prediabetes represent significant global health challenges, with physical activity (PA) being essential for disease management and prevention. Despite the well-documented benefits, many individuals with (pre)diabetes remain insufficiently active. General practitioners (GP) provide an accessible platform for delivering interventions; however, integrating PA interventions into routine care is hindered by resource constraints. OBJECTIVES: The ENERGISED trial aims to address these barriers through an innovative GP-initiated mHealth intervention combining wearable technology and just-in-time adaptive interventions. METHODS: The ENERGISED trial is a pragmatic, 12-month, multicentre, randomised controlled trial, assessing a GP-initiated mHealth intervention to increase PA and reduce sedentary behaviour in patients with type 2 diabetes and prediabetes. The primary outcome is daily step count, assessed via wrist-worn accelerometry. The primary analysis follows the intention-to-treat principle, using mixed models for repeated measures. Missing data will be handled under the missing-at-random assumption, with sensitivity analyses exploring robustness through reference-based multiple imputation. The trial incorporates the estimand framework to provide transparent and structured treatment effect estimation. DISCUSSION: This statistical analysis plan outlines a robust approach to addressing participant non-adherence, protocol violations, and missing data. By adopting the estimand framework and pre-specified sensitivity analyses, the plan ensures methodological rigour while enhancing the interpretability and applicability of results. CONCLUSIONS: The ENERGISED trial leverages innovative mHealth strategies within primary care to promote PA in individuals with (pre)diabetes. The pre-specified statistical framework provides a comprehensive guide for analysing trial data and contributes to advancing best practices in behavioural intervention trials for public health. TRIAL REGISTRATION: ClinicalTrials.gov NCT05351359 . Registered on April 28, 2022.

• MeSH
• Accelerometry MeSH
• Exercise * MeSH
• Diabetes Mellitus, Type 2 * therapy   psychology   diagnosis   MeSH
• Fitness Trackers MeSH
• Humans MeSH
• Multicenter Studies as Topic MeSH
• Wearable Electronic Devices MeSH
• Pragmatic Clinical Trials as Topic MeSH
• General Practice * methods   MeSH
• Prediabetic State * therapy   psychology   diagnosis   MeSH
• Sedentary Behavior * MeSH
• Telemedicine * statistics & numerical data   MeSH
• Check Tag
• Humans MeSH
• Publication type
• Journal Article MeSH
• Clinical Trial Protocol MeSH