Physical activity in pregnancy:a mixed methods process evaluation of the FitMum randomised controlled trial interventions

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. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12889-022-14717-1

Atomoxetine in Early Pregnancy and the Prevalence of Major Congenital Malformations : A Multinational Study

Funding Information: Submitted: February 18, 2022; accepted September 20, 2022. Published online: January 16, 2023. Relevant financial relationships: Dr Bröms has been a speaker for Takeda and has been involved in projects at Centre for Pharmacoepidemiology, Karolinska Institutet, partly financed by Janssen, Pfizer, and UCB, all unrelated to this project. Dr Hernandez-Diaz is an investigator on grants to her institution from Takeda for unrelated studies, has received personal consulting fees from UCB and Roche outside the submitted work, and has served as an epidemiologist with the North America AED pregnancy registry and as a scientific advisor for the National Pregnancy Registry for Psychiatric Medication and for Pregistry, which are funded by multiple companies. Dr Huybrechts reports being an investigator on research grants to her institution from Takeda and UCB for unrelated studies. Mr Karlsson is employed at the Centre for Pharmacoepidemiology, Karolinska Institutet, which receives grants from several entities (pharmaceutical companies, regulatory authorities, and contract research organizations) for performance of drug safety and drug utilization studies, with no relation to the work reported in this article. Dr Nørgaard is employed at the Department of Clinical Epidemiology, Aarhus University Hospital, which receives funding for other studies from companies in the form of research grants to (and administered by) Aarhus University. None of these studies has any relation to the present study. Dr Reutfors is employed at the Centre for Pharmacoepidemiology, Karolinska Institutet, which receives grants from several entities (pharmaceutical companies, regulatory authorities, and contract research organizations) for performance of drug safety and drug utilization studies, with no relation to the work reported in this article. Dr Sørensen is employed at the Department of Clinical Epidemiology, Aarhus University Hospital, which receives funding for other studies from companies in the form of research grants to (and administered by) Aarhus University. None of these studies have any relation to the present study. Dr Zoega is employed at the Centre for Big Data Research in Health, UNSW Sydney, which received funding from AbbVie Australia in 2020 to conduct research, unrelated to this study. AbbVie did not have any knowledge of, or involvement in, this study. Dr Kieler is employed at the Centre for Pharmacoepidemiology, Karolinska Institutet, which receives grants from several entities (pharmaceutical companies, regulatory authorities, and contract research organizations) for performance of drug safety and drug utilization studies, with no relation to the work reported in this article. Drs Bateman, Einarsdóttir, Engeland, Furu, Gissler, Klungsøyr, and Lahesmaa-Korpinen; Mr Kristiansen; and Ms Mogun report no conflicts of interest. Funding/support: This study was supported by the Söderström-König Foundation (SLS-664411); the Swedish Society of Medicine (SLS-689141); and the Stockholm Region (clinical postdoc appointment SLL-20170670); partly supported by the Research Council of Norway through its Centres of Excellence funding scheme (Project# 262700); NordForsk as part of the Nordic Pregnancy Drug Safety Studies (NorPreSS; Project# 83539); the Research Council of Norway as part of the International Pregnancy Drug Safety Studies (InPreSS; Project# 273366); UNSW Scientia Award (to H.Z.); The Drugs and Pregnancy project, funded by the Finnish Institute for Health and Welfare (THL), the Finnish Medicines Agency (FIMEA), and the Social Insurance Institution of Finland (Kela); the National Institute of Child Health and Human Development (R21 HD092879); and the National Institute of Mental Health (R01 MH116194). Role of the sponsor: The funding sources had no role in the design and conduct of the study or in the decision to publish. Previous presentation: An oral presentation of this work (title: ADHD Drugs During Pregnancy and the Risk of Congenital Malformations: A Study from the International Pregnancy Safety Study [InPreSS] Consortium) was made at the International Conference of Pharmacoepidemiology and Drug Safety; Montreal, Canada; August 26-30 2017. Ethical approval: The study was approved by the Regional Ethical Review Board in Stockholm, Sweden (2015/1826-31/2); the National Bioethics Committee in Iceland (VSNb201860017/03.01); the Steering Committee of the Drugs and Pregnancy Project; the Norwegian Data Inspectorate and the Regional Ethics Committee for Medical Research of South/East Norway); and the Danish Data Protection Agency (2015-57-0002). The use of the US data was approved by the Institutional Review Board of Brigham and Women’s Hospital, which granted a waiver of informed consent. Additional information: The data in this study were obtained from national health registers in Denmark, Iceland, Norway, and Sweden and the US Medicaid Analytic eXtract and cannot be made publicly available in their entirety due to national laws and data privacy. ORCID: Gabriella Bröms: https://orcid.org/0000-0002-2423-1968; Johan Reutfors: https://orcid. org/0000-0003-1372-4262; Mika Gissler: https:// orcid.org/0000-0001-8254-7525; Kari Klungsøyr: https://orcid.org/0000-0003-2482-1690; Mette Nørgaard: https://orcid.org/0000-0001-6110-5891; Anders Engeland: https://orcid.org/0000-0001-5620-9207; Anna-Maria Lahesmaa-Korpinen: https://orcid.org/0000-0003-1062-2893; Krista Huybrechts: https://orcid.org/0000-0001-5805-8430; Kari Furu: https://orcid.org/0000-0003-2245-0179; Kristjana Einarsdóttir: https://orcid.org/0000-0003-4931-7650; Henrik Toft Sørensen: https:// orcid.org/0000-0003-4299-7040; Helga Zoega: https://orcid.org/0000-0003-0761-9028 Supplementary material: Available at Psychiatrist.com. Publisher Copyright: © 2023 The Authors. Published by Physicians Postgraduate Press, Inc.Objective: Most research on safety of attention-deficit/hyperactivity disorder (ADHD) medications during pregnancy concerns central nervous system stimulants, while little is known about the safety of atomoxetine, a primary treatment alternative. We assessed the prevalence of major congenital malformations overall, and cardiac malformations and limb malformations specifically, after first-trimester exposure. Methods: In this cohort study, we included all approximately 2.4 million pregnancies ending in live births recorded in the population-based nationwide health registers of Denmark, Iceland, Norway, and Sweden (2003-2017) and approximately 1.8 million publicly insured pregnancies ending in live births recorded in the US Medicaid Analytic eXtract (MAX, 2001-2013) health care claims database. We compared the prevalence of major congenital malformations in the newborn among pregnancies exposed and unexposed to atomoxetine. For each country, we calculated prevalence ratios (PRs), crude and stratified by propensity scores (PSs). We pooled the country-specific PS strata to obtain a PR adjusted for potential confounding factors. Results: We identified 368 pregnancies exposed to atomoxetine during the first trimester in the 4 Nordic countries and 622 in the US. The pooled crude PR for any major congenital malformation was 1.18 (95% CI, 0.88-1.60), and the adjusted PR was 0.99 (95% CI, 0.74-1.34). For cardiac malformations, the adjusted PR was 1.34 (95% CI, 0.86-2.09). For limb malformations, the adjusted PR was 0.90 (95% CI, 0.38-2.16). Conclusions: After atomoxetine exposure in early pregnancy, we observed no increase in major congenital malformations overall and, although with some uncertainty due to sample size, no statistically increased risk estimates for cardiac malformations and limb malformations.Peer reviewe

A Typology of Transition Patterns Involving Long-Term NEET Episodes: Accumulation of Risk and Adversity

This paper uses Danish population-based administrative registers to study contemporary school-to-work transitions among young adults who experience long-term NEET episodes between age 16 and 20. By applying sequence analysis and clustering, this paper identifies five distinct transition patterns. Using this typology as the outcome variable in multinomial regression the paper offers insight into how experiences and circumstances, developing until age 16, can affect the subsequently unfolding transition process. Finally, the paper looks ahead and describes whether transitional difficulty accumulates into early adulthood. While one transition pattern stands out as more stable and less worrying, three of the remaining four demonstrate how transitional difficulty between age 16 and 20 develops as precarious patterns of attachment to well-established systems within the Danish welfare state. It is further established that various childhood risk factors significantly increase the odds of experiencing precarious transition patterns. Finally, the analyses demonstrate how instability and risk during childhood and school-to-work transition extend into early adulthood for a large part of the study population

Incentive effects of cash benefit among low-skilled young adults: Applying a regression discontinuity design.

In 2014, the Danish Government implemented an active labour market reform directed at unemployed young adults under 30 years of age with low educational qualifications. The reform replaced the (unemployment) cash benefits with a lower education benefit for many of the unemployed aged under 30 and obliged the low-skilled in this group to enrol in a regular general or vocational (VET) education program. This paper exploits the sharp discontinuity that occurs at age 30 to estimate the joint effect of higher benefits and the cessation of educational obligations on the share receiving cash benefits and the share enrolled in education. We estimate the effects by applying a regression discontinuity design. We report results for the group of low educated young adults and for subgroups facing different economic incentives. The results establish that reaching age 30 creates an incentive to apply for cash benefits, and we find strong evidence that a significant increase in the share of cash benefit recipients relates to a corresponding reduction in the share of young adults enrolled in education. When including subgroups the size of the effect increases, and the results demonstrate that the effects are strongest among previous education benefit recipients. This indicates that the results are mainly driven mainly by individuals reverting to cash benefits