Andreas Kryger Jensen
Current Organizations / Institutes
The organizations/institutes from the scholar's latest article
Previous Organizations / Institutes
The organizations / institutes from the scholar's other articles in the past ten years
Research Subjects
Andreas Kryger Jensen has a total of 101 co-authors. Here are the top co-authors by number of shared publications:
- Ellen Løkkegaard
Department of Gynaecology and Obstetrics, Nordsjællands Hospital, Hillerød, Denmark
5 shared publications - Stig Molsted
Department of Physiotherapy and Occupational Therapy Copenhagen University Hospital–North Zealand Denmark
4 shared publications - Ulrik Pedersen-Bjergaard
Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark
4 shared publications - Bente Stallknecht
Department of Biomedical Sciences, University of Copenhagen, 2200 Copenhagen, Denmark
3 shared publications - Caroline Borup Roland
Department of Biomedical Sciences, University of Copenhagen, 2200 Copenhagen, Denmark
3 shared publications - Claus Thorn Ekstrøm
Section of Biostatistics, Department of Public Health, University of Copenhagen, Denmark
3 shared publications
Latest Publications
- 20 November 2025
- Published by Springer Nature in TEST
- Vol. 35 (1) , 211-231
Computationally efficient multilevel Gaussian process regression for functional data observed under completely or partially regular sampling designs
- 20 November 2025
- Published by Springer Nature in TEST
- Vol. 35 (1) , 211-231
Computationally efficient multilevel Gaussian process regression for functional data observed under completely or partially regular sampling designs
- Open Access
- 20 July 2025
- Published by Springer Nature in Statistics and Computing
- Vol. 35 (5) , 1-16
DeepJAM: Joint alignment of multivariate quasi-periodic functional data using deep learning
The joint alignment of multivariate functional data plays an important role in various fields such as signal processing, neuroscience and medicine, including the statistical analysis of data from wearable devices. Traditional methods often ignore the phase variability and instead focus on the variability in the observed amplitude. We present a novel method for joint alignment of multivariate quasi-periodic functions using deep neural networks, decomposing, but retaining all the information in the data by preserving both phase and amplitude variability. Our proposed neural network uses a special activation of the output that builds on the unit simplex transformation, and we utilize a loss function based on the Fisher-Rao metric to train our model. Furthermore, our method is unsupervised and can provide an optimal common template function as well as subject-specific templates. We demonstrate our method on two simulated datasets and one real example, comprising data from 12-lead 10s electrocardiogram recordings.
- 20 July 2025
- Published by Springer Nature in Statistics and Computing
- Vol. 35 (5) , 1-16
Open AccessDeepJAM: Joint alignment of multivariate quasi-periodic functional data using deep learning
The joint alignment of multivariate functional data plays an important role in various fields such as signal processing, neuroscience and medicine, including the statistical analysis of data from wearable devices. Traditional methods often ignore the phase variability and instead focus on the variability in the observed amplitude. We present a novel method for joint alignment of multivariate quasi-periodic functions using deep neural networks, decomposing, but retaining all the information in the data by preserving both phase and amplitude variability. Our proposed neural network uses a special activation of the output that builds on the unit simplex transformation, and we utilize a loss function based on the Fisher-Rao metric to train our model. Furthermore, our method is unsupervised and can provide an optimal common template function as well as subject-specific templates. We demonstrate our method on two simulated datasets and one real example, comprising data from 12-lead 10s electrocardiogram recordings.
- Open Access
Cohort profile: TheSmartSleep Study, Denmark, combining evidence from survey, clinical and tracking data
Purpose: TheSmartSleep Studyis established to comprehensively assess the impact of night-time smartphone use on sleep patterns and health. An innovative combination of large-scale repeated survey information, high-resolution sensor-driven smartphone data, in-depth clinical examination and registry linkage allows for detailed investigations into multisystem physiological dysregulation and long-term health consequences associated with night-time smartphone use and sleep impairment.Participants: TheSmartSleep Studyconsists of three interconnected data samples, which combined include 30 673 individuals with information on smartphone use, sleep and health. Subsamples of the study population also include high-resolution tracking data (n=5927) collected via a customised app and deep clinical phenotypical data (n=245). A total of 7208 participants are followed in nationwide health registries with full data coverage and long-term follow-up.Findings to date: We highlight previous findings on the relation between smartphone use and sleep in theSmartSleep Study, and we evaluate the interventional potential of the citizen science approach used in one of the data samples. We also present new results from an analysis in which we use 803 000 data points from the high-resolution tracking data to identify clusters of temporal trajectories of night-time smartphone use that characterise distinct use patterns. Based on these objective tracking data, we characterise four clusters of night-time smartphone use.Future plans: The unprecedented size and coverage of theSmartSleep Studyallow for a comprehensive documentation of smartphone activity during the entire sleep span. The study has been expanded by linkage to nationwide registers, which allow for further investigations into the long-term health and social consequences of night-time smartphone use. We also plan new rounds of data collection in the coming years.
Open AccessCohort profile: TheSmartSleep Study, Denmark, combining evidence from survey, clinical and tracking data
Purpose: TheSmartSleep Studyis established to comprehensively assess the impact of night-time smartphone use on sleep patterns and health. An innovative combination of large-scale repeated survey information, high-resolution sensor-driven smartphone data, in-depth clinical examination and registry linkage allows for detailed investigations into multisystem physiological dysregulation and long-term health consequences associated with night-time smartphone use and sleep impairment.Participants: TheSmartSleep Studyconsists of three interconnected data samples, which combined include 30 673 individuals with information on smartphone use, sleep and health. Subsamples of the study population also include high-resolution tracking data (n=5927) collected via a customised app and deep clinical phenotypical data (n=245). A total of 7208 participants are followed in nationwide health registries with full data coverage and long-term follow-up.Findings to date: We highlight previous findings on the relation between smartphone use and sleep in theSmartSleep Study, and we evaluate the interventional potential of the citizen science approach used in one of the data samples. We also present new results from an analysis in which we use 803 000 data points from the high-resolution tracking data to identify clusters of temporal trajectories of night-time smartphone use that characterise distinct use patterns. Based on these objective tracking data, we characterise four clusters of night-time smartphone use.Future plans: The unprecedented size and coverage of theSmartSleep Studyallow for a comprehensive documentation of smartphone activity during the entire sleep span. The study has been expanded by linkage to nationwide registers, which allow for further investigations into the long-term health and social consequences of night-time smartphone use. We also plan new rounds of data collection in the coming years.
- Open Access
- 28 August 2023
- Published by Springer Nature in Reproductive Sciences
- Vol. 30 (12) , 3597-3609
A Novel Approach to Predicting Early Pregnancy Outcomes Dynamically in a Prospective Cohort Using Repeated Ultrasound and Serum Biomarkers
This study aimed to develop a dynamic model for predicting outcome during the first trimester of pregnancy using baseline demographic data and serially collected blood samples and transvaginal sonographies. A prospective cohort of 203 unselected women with an assumed healthy pregnancy of < 8 weeks’ gestation was followed fortnightly from 4–14 weeks’ gestation until either miscarriage or confirmed first trimester viability. The main outcome was development of a model to predict outcome from gestational age-dependent hazard ratios using both baseline and updated serial data from each visit. Secondary outcomes were descriptions of risk factors for miscarriage. The results showed that 18% of the women experienced miscarriages. A fetal heart rate detected before 8 weeks’ gestation indicated a 90% (95% CI 85–95%) chance of subsequent delivery. Maternal age (≥ 35 years), insufficient crown-rump-length (CRL) and mean gestational sac diameter (MSD) development, and presence of bleeding increased the risk of miscarriage. Serum biomarkers, including hCG, progesterone, and estradiol, were found to impact the risk of miscarriage with estradiol as the most important. The best model to predict miscarriage was a combination of maternal age, vaginal bleeding, CRL, and hCG. The second-best model was the sonography-absent model of maternal age, bleeding, hCG, and estradiol. This study suggests that combining maternal age, and evolving data from hCG, estradiol, CRL, and bleeding could be used to predict fetal outcome during the first trimester of pregnancy.Trial registration ClinicalTrials.gov identifier: NCT02761772.
- 28 August 2023
- Published by Springer Nature in Reproductive Sciences
- Vol. 30 (12) , 3597-3609
Open AccessA Novel Approach to Predicting Early Pregnancy Outcomes Dynamically in a Prospective Cohort Using Repeated Ultrasound and Serum Biomarkers
This study aimed to develop a dynamic model for predicting outcome during the first trimester of pregnancy using baseline demographic data and serially collected blood samples and transvaginal sonographies. A prospective cohort of 203 unselected women with an assumed healthy pregnancy of < 8 weeks’ gestation was followed fortnightly from 4–14 weeks’ gestation until either miscarriage or confirmed first trimester viability. The main outcome was development of a model to predict outcome from gestational age-dependent hazard ratios using both baseline and updated serial data from each visit. Secondary outcomes were descriptions of risk factors for miscarriage. The results showed that 18% of the women experienced miscarriages. A fetal heart rate detected before 8 weeks’ gestation indicated a 90% (95% CI 85–95%) chance of subsequent delivery. Maternal age (≥ 35 years), insufficient crown-rump-length (CRL) and mean gestational sac diameter (MSD) development, and presence of bleeding increased the risk of miscarriage. Serum biomarkers, including hCG, progesterone, and estradiol, were found to impact the risk of miscarriage with estradiol as the most important. The best model to predict miscarriage was a combination of maternal age, vaginal bleeding, CRL, and hCG. The second-best model was the sonography-absent model of maternal age, bleeding, hCG, and estradiol. This study suggests that combining maternal age, and evolving data from hCG, estradiol, CRL, and bleeding could be used to predict fetal outcome during the first trimester of pregnancy.Trial registration ClinicalTrials.gov identifier: NCT02761772.
- Open Access
- 31 March 2023
- Published by MDPI AG in International Journal of Environmental Research and Public Health
- Vol. 20 (7) , 5359
Effects of Two Physical Activity Interventions on Sleep and Sedentary Time in Pregnant Women
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.
- 31 March 2023
- Published by MDPI AG in International Journal of Environmental Research and Public Health
- Vol. 20 (7) , 5359
Open AccessEffects of Two Physical Activity Interventions on Sleep and Sedentary Time in Pregnant Women
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.
- Open Access
- 20 July 2022
- Published by JMIR Publications Inc. in Journal of Medical Internet Research
- Vol. 24 (7) , e37699
Effects of Structured Supervised Exercise Training or Motivational Counseling on Pregnant Women’s Physical Activity Level: FitMum - Randomized Controlled Trial
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
- 20 July 2022
- Published by JMIR Publications Inc. in Journal of Medical Internet Research
- Vol. 24 (7) , e37699
Open AccessEffects of Structured Supervised Exercise Training or Motivational Counseling on Pregnant Women’s Physical Activity Level: FitMum - Randomized Controlled Trial
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
- 17 June 2022
- Published by Springer Nature in AStA Advances in Statistical Analysis
- Vol. 107 (1-2) , 295-311
Having a ball: evaluating scoring streaks and game excitement using in-match trend estimation
Many popular sports involve matches between two teams or players where each team have the possibility of scoring points throughout the match. While the overall match winner and result is interesting, it conveys little information about the underlying scoring trends throughout the match. Modeling approaches that accommodate a finer granularity of the score difference throughout the match is needed to evaluate in-game strategies, discuss scoring streaks, teams strengths, and other aspects of the game. We propose a latent Gaussian process to model the score difference between two teams and introduce the Trend Direction Index as an easily interpretable probabilistic measure of the current trend in the match as well as a measure of post-game trend evaluation. In addition we propose the Excitement Trend Index—the expected number of monotonicity changes in the running score difference—as a measure of overall game excitement. Our proposed methodology is applied to all 1143 matches from the 2019–2020 National Basketball Association season. We show how the trends can be interpreted in individual games and how the excitement score can be used to cluster teams according to how exciting they are to watch.
- 17 June 2022
- Published by Springer Nature in AStA Advances in Statistical Analysis
- Vol. 107 (1-2) , 295-311
Having a ball: evaluating scoring streaks and game excitement using in-match trend estimation
Many popular sports involve matches between two teams or players where each team have the possibility of scoring points throughout the match. While the overall match winner and result is interesting, it conveys little information about the underlying scoring trends throughout the match. Modeling approaches that accommodate a finer granularity of the score difference throughout the match is needed to evaluate in-game strategies, discuss scoring streaks, teams strengths, and other aspects of the game. We propose a latent Gaussian process to model the score difference between two teams and introduce the Trend Direction Index as an easily interpretable probabilistic measure of the current trend in the match as well as a measure of post-game trend evaluation. In addition we propose the Excitement Trend Index—the expected number of monotonicity changes in the running score difference—as a measure of overall game excitement. Our proposed methodology is applied to all 1143 matches from the 2019–2020 National Basketball Association season. We show how the trends can be interpreted in individual games and how the excitement score can be used to cluster teams according to how exciting they are to watch.
- 14 May 2022
- Published by Taylor & Francis in Scandinavian Journal of Clinical and Laboratory Investigation
- Vol. 82 (4) , 267-276
Reference serum percentile values of adiponectin, leptin, and adiponectin/leptin ratio in healthy Danish children and adolescents
The adipokines adiponectin and leptin play key roles in human metabolic regulation and have gained great attention as biomarkers for various metabolic pathologies. Though, pediatric reference values are few and needed. This study aims to establish age- and sex-specific adipokine reference percentiles based on healthy Danish school children. Further, it elucidates sex-specific differences in associations between z-scores of examined adipokines and metabolic variables. Serum adiponectin and serum leptin from 853 observations of healthy Danish schoolchildren aged 8–17 years (median 10.0) were quantified by immunoassays. Age- and sex-specific adipokine reference percentiles were calculated cross-sectionally using the LMS method, and adipokine z-scores were calculated from the fitted model. Multiple linear regression models were used to examine sex-specific differences in associations between adipokine z-scores and various metabolic variables. Girls had a higher median value of adiponectin (11.31 vs. 10.65 μg/mL, p < .001) and leptin (2.30 vs. 1.00 ng/mL, p < .001) and a lower median value of adiponectin/leptin ratio (4.64 vs. 10.76, p < .001) compared to boys. Sex-specific differences were found in associations between adiponectin z-score and HDL (p = .010), between leptin z-score and waist circumference z-score (p = .027) and LDL (p = .048), and between adiponectin/leptin ratio z-scores and waist circumference z-score (p = .044) and LDL (p = .040). Reference percentiles of adiponectin, leptin, and adiponectin/leptin ratio are presented in this paper. To our knowledge, this study is the first to demonstrate sex-specific differences in associations between adipokine z-scores and waist circumference z-score and lipids, respectively in healthy children and adolescents.
- 14 May 2022
- Published by Taylor & Francis in Scandinavian Journal of Clinical and Laboratory Investigation
- Vol. 82 (4) , 267-276
Reference serum percentile values of adiponectin, leptin, and adiponectin/leptin ratio in healthy Danish children and adolescents
The adipokines adiponectin and leptin play key roles in human metabolic regulation and have gained great attention as biomarkers for various metabolic pathologies. Though, pediatric reference values are few and needed. This study aims to establish age- and sex-specific adipokine reference percentiles based on healthy Danish school children. Further, it elucidates sex-specific differences in associations between z-scores of examined adipokines and metabolic variables. Serum adiponectin and serum leptin from 853 observations of healthy Danish schoolchildren aged 8–17 years (median 10.0) were quantified by immunoassays. Age- and sex-specific adipokine reference percentiles were calculated cross-sectionally using the LMS method, and adipokine z-scores were calculated from the fitted model. Multiple linear regression models were used to examine sex-specific differences in associations between adipokine z-scores and various metabolic variables. Girls had a higher median value of adiponectin (11.31 vs. 10.65 μg/mL, p < .001) and leptin (2.30 vs. 1.00 ng/mL, p < .001) and a lower median value of adiponectin/leptin ratio (4.64 vs. 10.76, p < .001) compared to boys. Sex-specific differences were found in associations between adiponectin z-score and HDL (p = .010), between leptin z-score and waist circumference z-score (p = .027) and LDL (p = .048), and between adiponectin/leptin ratio z-scores and waist circumference z-score (p = .044) and LDL (p = .040). Reference percentiles of adiponectin, leptin, and adiponectin/leptin ratio are presented in this paper. To our knowledge, this study is the first to demonstrate sex-specific differences in associations between adipokine z-scores and waist circumference z-score and lipids, respectively in healthy children and adolescents.
- Open Access
- 12 April 2022
- Published by Taylor & Francis in Global Health Action
- Vol. 15 (1) , 2034135
Scaling up context-tailored clinical guidelines and training to improve childbirth care in urban, low-resource maternity units in Tanzania: A protocol for a stepped-wedged cluster randomized trial with embedded qualitative and economic analyses (The PartoMa Scale-Up Study)
While facility births are increasing in many low-resource settings, quality of care often does not follow suit; maternal and perinatal mortality and morbidity remain unacceptably high. Therefore, realistic, context-tailored clinical support is crucially needed to assist birth attendants in resource-constrained realities to provide best possible evidence-based and respectful care. Our pilot study in Zanzibar suggested that co-created clinical practice guidelines (CPGs) and low-dose, high-frequency training (PartoMa intervention) were associated with improved childbirth care and survival. We now aim to modify, implement, and evaluate this multi-faceted intervention in five high-volume, urban maternity units in Dar es Salaam, Tanzania (approximately 60,000 births annually). This PartoMa Scale-up Study will include four main steps: I. Mixed-methods situational analysis exploring factors affecting care; II. Co-created contextual modifications to the pilot CPGs and training, based on step I; III. Implementation and evaluation of the modified intervention; IV. Development of a framework for co-creation of context-specific CPGs and training, of relevance in comparable fields. The implementation and evaluation design is a theory-based, stepped-wedged cluster-randomised trial with embedded qualitative and economic assessments. Women in active labour and their offspring will be followed until discharge to assess provided and experienced care, intra-hospital perinatal deaths, Apgar scores, and caesarean sections that could potentially be avoided. Birth attendants’ perceptions, intervention use and possible associated learning will be analysed. Moreover, as further detailed in the accompanying article, a qualitative in-depth investigation will explore behavioural, biomedical, and structural elements that might interact with non-linear and multiplying effects to shape health providers’ clinical practices. Finally, the incremental cost-effectiveness of co-creating and implementing the PartoMa intervention is calculated. Such real-world scale-up of context-tailored CPGs and training within an existing health system may enable a comprehensive understanding of how impact is achieved or not, and how it may be translated between contexts and sustained. Trial registration number: NCT04685668
- 12 April 2022
- Published by Taylor & Francis in Global Health Action
- Vol. 15 (1) , 2034135
Open AccessScaling up context-tailored clinical guidelines and training to improve childbirth care in urban, low-resource maternity units in Tanzania: A protocol for a stepped-wedged cluster randomized trial with embedded qualitative and economic analyses (The PartoMa Scale-Up Study)
While facility births are increasing in many low-resource settings, quality of care often does not follow suit; maternal and perinatal mortality and morbidity remain unacceptably high. Therefore, realistic, context-tailored clinical support is crucially needed to assist birth attendants in resource-constrained realities to provide best possible evidence-based and respectful care. Our pilot study in Zanzibar suggested that co-created clinical practice guidelines (CPGs) and low-dose, high-frequency training (PartoMa intervention) were associated with improved childbirth care and survival. We now aim to modify, implement, and evaluate this multi-faceted intervention in five high-volume, urban maternity units in Dar es Salaam, Tanzania (approximately 60,000 births annually). This PartoMa Scale-up Study will include four main steps: I. Mixed-methods situational analysis exploring factors affecting care; II. Co-created contextual modifications to the pilot CPGs and training, based on step I; III. Implementation and evaluation of the modified intervention; IV. Development of a framework for co-creation of context-specific CPGs and training, of relevance in comparable fields. The implementation and evaluation design is a theory-based, stepped-wedged cluster-randomised trial with embedded qualitative and economic assessments. Women in active labour and their offspring will be followed until discharge to assess provided and experienced care, intra-hospital perinatal deaths, Apgar scores, and caesarean sections that could potentially be avoided. Birth attendants’ perceptions, intervention use and possible associated learning will be analysed. Moreover, as further detailed in the accompanying article, a qualitative in-depth investigation will explore behavioural, biomedical, and structural elements that might interact with non-linear and multiplying effects to shape health providers’ clinical practices. Finally, the incremental cost-effectiveness of co-creating and implementing the PartoMa intervention is calculated. Such real-world scale-up of context-tailored CPGs and training within an existing health system may enable a comprehensive understanding of how impact is achieved or not, and how it may be translated between contexts and sustained. Trial registration number: NCT04685668
- Open Access
- 5 March 2022
- Published by JMIR Publications Inc. in JMIR Preprints
Effects of Structured Supervised Exercise Training or Motivational Counseling on Pregnant Women’s Physical Activity Level: FitMum - Randomized Controlled Trial (Preprint)
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. CLINICALTRIAL ClinicalTrials.gov NCT03679130; https://clinicaltrials.gov/ct2/show/NCT03679130 INTERNATIONAL REGISTERED REPORT RR2-10.1136/bmjopen-2020-043671
- 5 March 2022
- Published by JMIR Publications Inc. in JMIR Preprints
Open AccessEffects of Structured Supervised Exercise Training or Motivational Counseling on Pregnant Women’s Physical Activity Level: FitMum - Randomized Controlled Trial (Preprint)
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. CLINICALTRIAL ClinicalTrials.gov NCT03679130; https://clinicaltrials.gov/ct2/show/NCT03679130 INTERNATIONAL REGISTERED REPORT RR2-10.1136/bmjopen-2020-043671