Structured supervised exercise training or motivational counselling during pregnancy on physical activity level and health of mother and offspring: FitMum study protocol

Abstract

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.

Systematic review of process evaluations of interventions in trials investigating sedentary behaviour in adults

“…Overall 464 unique articles were identified once 14 duplicates were removed. Two reviewers completed title and abstract screening identifiying 29 for full-text screening; of these, 21 met our criteria, 8 are ongoing studies,56–63 8 are completed trials where a process evaluation was conducted but results are not available,64–71 and 5 are completed studies with process evaluation results available 72–76. As with the studies that were synthesised in our review, these included participants from a range of different ages and health conditions for example, insomnia disorder, diabetes, heart disease, hip fracture and obesity and generally focused on increasing physical activity, reducing sedentary behaviour or were lifestyle or weight loss interventions.…”

Effects of Structured Supervised Exercise Training or Motivational Counseling on Pregnant Women’s Physical Activity Level: FitMum - Randomized Controlled Trial

“…FitMum was a single-site randomized controlled trial (RCT) conducted from 2018-2021 at the Department of Gynecology and Obstetrics at Copenhagen University Hospital–North Zealand, Denmark [ 32 ]. A total of 220 healthy, inactive pregnant women with gestational ages of ≤15 weeks and 0 days were included (visit 1).…”

“…Secondary measures of PA were obtained by the Danish version of the Pregnancy Physical Activity Questionnaire (PPAQ-DK) [27,28] and by the gold standard doubly labeled water (DLW) technique [29][30][31]. The hypotheses were that both EXE and MOT would increase MVPA in pregnancy compared to CON and that EXE would be more effective than MOT [32,33]. In addition, the association between MVPA and the number of sessions attended was explored.…”

Adipositasprävention in den ersten 1000 Tagen

“…Sie lassen sich leicht in den Alltag der Frauen integrieren, sind kostengünstig und ermöglichen einen flächendeckenden Einsatz. Im Rahmen von Lebensstilinterventionsstudien finden derzeit sowohl kommerzielle Apps wie Garmin oder Fitbit als auch von Forschungsgruppen entwickelte Apps Anwendung 50 51 52 53 54 55 . Die Entwicklung und Erprobung einer evidenzbasierten App erfolgt zumeist in mehreren, oft iterativen Schritten, unter Einbezug von qualitativen und quantitativen Methoden.…”