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The main objective of the study was to investigate the effects of prenatal exercise interventions on maternal body composition at 28 weeks gestation and 7–14 days after delivery. We also explored associations between physical activity (PA) per se and body composition. This study presents secondary outcomes of the FitMum randomized controlled trial, which included healthy inactive pregnant women at gestational age ≤ 15+0 weeks. They were randomized to structured supervised exercise training, motivational counselling on PA, or standard care. Maternal body composition was measured by doubly labeled water at 28 weeks gestation ( n = 134) and by dual-energy X-ray absorptiometry scan 7–14 days after delivery ( n = 117). PA, including moderate-to-vigorous-intensity PA (MVPA), active kilocalories, and steps, were measured continuously from inclusion to delivery by a wrist-worn activity tracker. One hundred fifty pregnant women were included with a median pre-pregnancy body mass index (BMI) of 24.1 (21.6–27.9) kg/m 2 . We found no differences between groups in fat mass, fat percentage or fat-free mass at 28 weeks gestation or 7–14 days after delivery. Visceral adipose tissue mass and bone mineral density measured 7–14 days after delivery did not differ between groups either. Linear regression analyses adjusted for pre-pregnancy BMI showed that a higher number of daily steps was associated with lower fat mass, fat percentage, and visceral adipose tissue mass at 28 weeks gestation and 7–14 days after delivery. Active kilocalories during pregnancy was positively associated with fat-free mass 7–14 days after delivery. Neither structured supervised exercise training nor motivational counselling on PA during pregnancy affected maternal body composition at 28 weeks gestation or 7–14 days after delivery compared to standard care. Interestingly, when adjusted for pre-pregnancy BMI, higher number of daily steps was associated with lower fat content during pregnancy and after delivery, whereas MVPA and active kilocalories were not. Trial registration: ClinicalTrials.gov; NCT03679130 ; 20/09/2018.

Postpartum physical activity (PA) is linked to improved mental health and sleep. Yet, many women do not return to pre-pregnancy PA levels, and sedentary behavior may increase. This study mapped PA, sedentary time, and sleep from early pregnancy to one year postpartum, and examined if prenatal PA interventions affect these outcomes postpartum. In the FitMum randomized controlled trial, 220 healthy, inactive pregnant women (< 15 + 0 weeks gestation) were assigned to standard care (CON), supervised exercise (EXE), or motivational PA counselling (MOT). Participants wore wrist-worn activity trackers from inclusion to one year postpartum and completed the Pregnancy Physical Activity Questionnaire and Pittsburgh Sleep Quality Index. We found that postpartum daily steps increased by ~ 2,000 compared to late pregnancy ( p  < 0.001), while moderate-to-vigorous-intensity PA (MVPA) declined ( p  < 0.001). Sedentary time remained similar. Sleep duration dropped postpartum in the first three months ( p  < 0.05), while sleep quality improved ( p  = 0.006). Prenatal PA interventions had minimal impact postpartum, however, EXE participants reported slightly better sleep than MOT at one year. In conclusion, PA patterns and sleep changed postpartum, with more daily steps, less MVPA, and reduced sleep duration. Prenatal PA interventions had limited effect. Longitudinal studies are needed to optimize timing of interventions for maternal health. The study is registered at ClinicalTrials.gov; NCT03679130;20/09/2018.

Background A physically active lifestyle is beneficial during pregnancy. However, little is known about physical activity (PA) behaviour and psychosocial factors in women during and after pregnancy. This study examined exercise behavioural regulation, exercise self-efficacy, health-related quality of life, sickness absence and musculoskeletal pain in pregnant women offered either structured supervised exercise training, motivational counselling on PA, or standard prenatal care in the FitMum randomised controlled trial. Methods Two hundred and eighteen healthy inactive pregnant women were randomised to structured supervised exercise training ( n  = 87), motivational counselling on PA ( n  = 86) or standard prenatal care ( n  = 45). The women answered the Behavioural Regulation in Exercise Questionnaire-2 (BREQ-2), the Pregnancy Exercise Self-Efficacy Scale (P-ESES-DK) and the Short Form 36 Health Survey Questionnaire (SF-36) at baseline (gestational age (GA) of max 15 weeks), GA 28 and 34 weeks, and one year after delivery. Sickness absence and low back and/or pelvic girdle pain were likewise reported in questionnaires at baseline and GA 28 weeks. Results Participants offered structured supervised exercise training or motivational counselling on PA had higher autonomous motivation for exercise during pregnancy compared with participants receiving standard prenatal care (e.g., difference in intrinsic regulation at GA 28 weeks, structured supervised exercise training vs. standard prenatal care: mean difference in score 0.39 [0.16; 0.64], p  < 0.001). Participants offered structured supervised exercise training also had higher exercise self-efficacy during pregnancy (e.g., GA 28 weeks, structured supervised exercise training vs. standard prenatal care: mean difference in score 6.97 [2.05; 12.02], p  = 0.005). All participants reported high exercise self-efficacy at baseline and medium exercise self-efficacy during pregnancy and one year after delivery. No differences were found between groups in health-related quality of life, sickness absence or low back and/or pelvic girdle pain during pregnancy. No group differences were found one year after delivery. Conclusion Structured supervised exercise training and motivational counselling on PA had important effects on autonomous exercise motivation during pregnancy. Exercise self-efficacy was also increased with structured supervised exercise training compared to standard prenatal care. No group differences in health-related quality of life, sickness absence, or pain were found during and after pregnancy. No effects were found one year post-delivery after intervention cessation. Trial registration The study was approved by the Danish National Committee on Health Research Ethics (#H-18011067) and the Danish Data Protection Agency (#P-2019–512). The study adheres to the principles of the Helsinki declaration. Written informed consent was obtained at inclusion.

Background: Physical activity (PA) during pregnancy is an effective and safe way to improve maternal health in uncomplicated pregnancies. However, compliance with PA recommendations remains low among pregnant women. Objective: The purpose of this study was to evaluate the effects of offering structured supervised exercise training (EXE) or motivational counseling on PA (MOT) during pregnancy on moderate-to-vigorous intensity physical activity (MVPA) level. Additionally, complementary measures of PA using the Pregnancy Physical Activity Questionnaire (PPAQ) and gold standard doubly labeled water (DLW) technique were investigated. The hypotheses were that both EXE and MOT would increase MVPA in pregnancy compared with standard care (CON) and that EXE would be more effective than MOT. In addition, the association between MVPA and the number of sessions attended was explored. Methods: A randomized controlled trial included 220 healthy, inactive pregnant women with a median gestational age of 12.9 (IQR 9.4-13.9) weeks. A total of 219 women were randomized to CON (45/219), EXE (87/219), or MOT (87/219). The primary outcome was MVPA (minutes per week) from randomization to the 29th gestational week obtained by a wrist-worn commercial activity tracker (Vivosport, Garmin International). PA was measured by the activity tracker throughout pregnancy, PPAQ, and DLW. The primary outcome analysis was performed as an analysis of covariance model adjusting for baseline PA. Results: The average MVPA (minutes per week) from randomization to the 29th gestational week was 33 (95% CI 18 to 47) in CON, 50 (95% CI 39 to 60) in EXE, and 40 (95% CI 30 to 51) in MOT. When adjusted for baseline MVPA, participants in EXE performed 20 (95% CI 4 to 36) minutes per week more MVPA than participants in CON (P=.02). MOT was not more effective than CON; EXE and MOT also did not differ. MVPA was positively associated with the number of exercise sessions attended in EXE from randomization to delivery (P=.04). Attendance was higher for online (due to COVID-19 restrictions) compared with physical exercise training (P=.03). Adverse events and serious adverse events did not differ between groups. Conclusions: Offering EXE was more effective than CON to increase MVPA among pregnant women, whereas offering MOT was not. MVPA in the intervention groups did not reach the recommended level in pregnancy. Changing the intervention to online due to COVID-19 restrictions did not affect MVPA level but increased exercise participation. Trial Registration: ClinicalTrials.gov NCT03679130; https://clinicaltrials.gov/ct2/show/NCT03679130 International Registered Report Identifier (IRRID): RR2-10.1136/bmjopen-2020-043671

Background In Saudi Arabia, the rapid growth of digital media and smartphone use has raised concerns about problematic usage and its impacts on well-being, especially among young people. Research on stakeholder perspectives regarding intervention strategies remains limited. Objective This study aimed to gather insights from societal stakeholders, including youth, parents, policymakers, industry leaders, clinicians, educators, and digital media users, to inform culturally tailored interventions for digital well-being in Saudi Arabia. Methods A purposeful non-random sample of 92 participants representing different stakeholder groups was recruited to complete an online survey, answering questions about their experiences and perspectives on digital media use. Primary stakeholder group was assigned based on participant self-selection. We analyzed distributions of categorical variables related to media use time, reasons for use, impacts, self-regulation strategies, and perceived effectiveness of interventions (e.g., education programs, media campaigns, Internet use restrictions). Results Of the participants, 63.0% were male, and 46.7% were under 25 years old. Regular digital media users, individuals with problematic Internet use, and clinicians/health professionals comprised 26.1%, 18.5%, and 18.5% of respondents, respectively. Extensive screen time was common, with 47.8% reporting four or more hours of recreational digital use on weekdays and 56.6% on weekends. Participants reported both positive impacts (e.g., social connections, school/work performance) and negative impacts (e.g., sleep disruption, reduced physical activity) of digital media use. Efforts to regulate media use were reported by 72.8%, with strategies like deleting apps or digital detoxes. At least 50.0% of participants endorsed all proposed intervention approaches as likely effective for improving digital well-being, with educational programs for parents, school programs, and regulatory apps receiving over 75.0% support. Children and adolescents were seen as key target groups for these interventions. Conclusions Findings from this diverse stakeholder sample suggest that digital well-being interventions in Saudi Arabia should prioritize youth, focusing on education-based approaches and apps for media regulation. Incorporating these perspectives can lead to culturally relevant interventions addressing the unique challenges of digital media use in Saudi Arabia. The generalizability of the findings may be limited due to sample size and potential overrepresentation of certain stakeholder groups.

Background Physical activity (PA) at moderate intensity is recommended for healthy pregnant women. The three-arm FitMum randomised controlled trial showed that it was possible to increase PA level during pregnancy with structured supervised exercise training (EXE) compared to standard care. Motivational counselling on PA (MOT) did not increase PA. This process evaluation aims to understand the implementation and mechanisms of impact of EXE and MOT. Methods A mixed methods process evaluation was conducted using the UK Medical Research Council’s process evaluation framework by assessing implementation ( reach, fidelity, and dose ) and mechanisms of impact of the two interventions provided to pregnant women in FitMum. Data was collected both quantitatively ( n  = 220) and qualitatively ( n  = 20). Results The FitMum trial reached educated pregnant women (80% having an educational level ≥ bachelor’s degree) with high autonomy of everyday life. Most participants (58%) were recruited at their first-trimester ultrasonic scan. Reasons to participate were personal (91%) and altruistic (56%). The intervention dose was delivered as intended with high fidelity in the original physical intervention setup and in the altered online setup during the COVID-19 restrictions. A low dose received in EXE (1.3 [95% CI, 1.1; 1.5] sessions/week) was partly explained by the pre-scheduled EXE sessions favouring participants with a flexible everyday life and a supportive social network. Dose received in EXE increased during online intervention delivery. Participants in MOT received 5.2 [4.7; 5.7] of 7 sessions. Mechanisms of impact comprised a perception of intervention commitment among participants in EXE due to the scheduled EXE sessions, whereas participants in MOT considered themselves as PA self-determined. PA was considered as constrained activities in EXE and included in daily activities in MOT. Conclusion The FitMum interventions was delivered with high fidelity . During COVID-19, the dose received in EXE increased compared to the previous physical setup. Mechanisms of impact as commitment, perception of empowerment and perception of PA as well as the paradox between prioritising PA and family and the need of a flexible everyday life need to be considered when offering pregnant women PA interventions. Future interventions should consider a combination of physical and online exercise training for pregnant women.

IntroductionA physically active lifestyle during pregnancy improves maternal and offspring health but can be difficult to follow. In Denmark, less than 40% of pregnant women meet physical activity (PA) recommendations. The FitMum study aims to explore strategies to increase PA during pregnancy among women with low PA and assess the health effects of PA. This paper presents the FitMum protocol, which evaluates the effects of structured supervised exercise training or motivational counselling supported by health technology during pregnancy on PA level and health of mother and offspring.Methods and analysisA single-site three-arm randomised controlled trial that aims to recruit 220 healthy, pregnant women with gestational age (GA) no later than week 15 and whose PA level does not exceed one hour/week. Participants are randomised to one of three groups: structured supervised exercise training consisting of three weekly exercise sessions, motivational counselling supported by health technology or a control group receiving standard care. The interventions take place from randomisation until delivery. The primary outcome is min/week of moderate-to-vigorous intensity PA (MVPA) as determined by a commercial activity tracker, collected from randomisation until GA of 28 weeks and 0-6 days, and the secondary outcome is gestational weight gain (GWG). Additional outcomes are complementary measures of PA; clinical and psychological health parameters in participant, partner and offspring; analyses of blood, placenta and breastmilk samples; process evaluation of interventions; and personal understandings of PA.Ethics and disseminationThe study is approved by the Danish National Committee on Health Research Ethics (# H-18011067) and the Danish Data Protection Agency (# P-2019-512). Findings will be disseminated via peer-reviewed publications, at conferences, and to health professionals via science theatre performances.Trial registration numberNCT03679130.Protocol versionThis paper was written per the study protocol version 8 dated 28 August 2019.

ObjectivesWe aimed to compare Garmin-estimated daily minutes of moderate-to-vigorous-intensity physical activity (MVPA) with daily minutes of MVPA assessed using heart rate (HR) thresholds based on maximum HR and HR reserve (HRR), respectively. Furthermore, we explored pregnancy-related HR changes.MethodsThe FitMum study included 220 healthy pregnant women before gestational age week 15+0 wearing Garmin vívosport activity trackers continuously until delivery. The activity trackers measured MVPA based on a proprietary algorithm including HR and accelerometry (model 1). We assessed MVPA as time above 64% of maximum HR with (model 2a) and without (model 2b) a minimum of 10 consecutive minutes of MVPA. In model 3, we assessed MVPA as time above 40% of HRR.ResultsModel 2a assigned less MVPA compared with model 1 (mean bias: −3.66 min/day). Model 2b assigned more MVPA compared with model 1 (mean bias: 16.82 min/day) and Model 2a (mean bias: 20.48 min/day). Model 3 assigned more MVPA compared with model 2b (mean bias: 12.00 min/day). Resting and average HR increased during pregnancy.ConclusionUsing HR for assessing MVPA offers transparency. The Garmin algorithm (model 1) assigned more MVPA compared with the HR model (model 2a). Removing the 10-min bout criterion resulted in more MVPA (Model 2a vs 2b). Using the HRR for assessing MVPA (model 3) resulted in more MVPA compared with using the maximum HR (model 2b). Resting and average HR resembled findings from previous studies.

Pregnancy is often associated with poor sleep and high sedentary time (SED). We investigated the effect of physical activity (PA) interventions on sleep and SED in pregnant women. A secondary analysis of a randomized controlled trial (n = 219) explored the effect of structured supervised exercise training (EXE) or motivational counseling on PA (MOT) compared to standard prenatal care (CON) on sleep and SED during pregnancy. Three times during pregnancy, sleep was determined by the Pittsburgh Sleep Quality Index (PSQI) and SED by the Pregnancy Physical Activity Questionnaire (PPAQ). Also, a wrist-worn consumer activity tracker measured sleep and SED continuously. Data from the activity tracker confirmed that sleep time decreases, and SED increases by approx. 30 and 24 min/day, respectively, from baseline (maximum gestational age (GA) week 15) to delivery. Compared to CON, the global PSQI score was better for EXE in GA week 28 (−0.8 [−1.5; −0.1], p = 0.031) and for both EXE and MOT in GA week 34 (−1 [−2; −0.5], p = 0.002; −1 [−2; −0.1], p = 0.026). In GA week 28, SED (h/day) from PPAQ was lower in EXE compared to both CON and MOT (−0.69 [−1; −0.0], p = 0.049; −0.6 [−1.0; −0.02], p = 0.042). In conclusion, PA interventions during pregnancy improved sleep quality and reduced SED.