Healthy living in pregnancy: a cluster-randomized controlled trial to prevent excessive gestational weight gain - rationale and design of the GeliS study

Abstract

BackgroundRecent studies suggest that excessive gestational weight gain (GWG) leads to adverse maternal and fetal outcomes including weight retention in the mother and an increased risk of childhood obesity in the offspring.The aim of the GeliS study is to examine the effect of a lifestyle intervention programme during pregnancy to avoid excessive GWG and, hence, to reduce pregnancy and obstetric complications as well as the risk of maternal and offspring obesity.Methods and designThe GeliS study is a multicentre cluster-randomized controlled trial. A total number of 2500 pregnant women (singleton pregnancy) with a pre-pregnancy BMI ≥ 18.5 kg/m2 and ≤ 40 kg/m2 will be recruited in practices of gynaecologists and midwives in ten Bavarian regions. The intervention comprises three structured and individualised counselling sessions on a healthy diet, regular physical activity as well as weight monitoring during pregnancy and one session after delivery, respectively. The counselling sessions are attached to routine pre- and postnatal visits using standardised materials and procedures. In the control regions, general recommendations for a healthy lifestyle are given. An oral glucose tolerance test is offered to all participants.The primary outcome is the proportion of participants with excessive GWG. Secondary outcomes include pregnancy and obstetric complications such as frequency of gestational diabetes, preeclampsia and caesarean sections as well as weight retention in the mothers and BMI and other health variables in the offspring. A 5-year follow-up of both mothers and their infants is planned.DiscussionThe GeliS lifestyle intervention programme has been adapted to the existing routine health care system for pregnant women. If shown to be effective, it could be immediately implemented in routine care.Trial registrationThe study protocol is registered at the ClinicalTrials.gov Protocol Registration System (NCT01958307).

The Effect of Aerobic Exercises on Maternal Outcomes: A Randomized Controlled Clinical Trial

“…Moreover, several researches indicate that doing exercise could be introduced as a prophylactic method to reduce back pain in pregnant mothers (5,6). Following a regular exercise program can help females achieve positive mental effects, increase their self-confidence and prevent weight gain during pregnancy (7)(8)(9). Up to now, different results have been obtained regarding the effect of exercising in the pregnancy period.…”

Influencia del programa SWEP (Study Water Exercise Pregnant) en los resultados perinatales: protocolo de estudio

“…El beneficio no sólo llega a la madre, sino también al feto, pues disminuye el riesgo de macrosomía, lo que facilita un parto más fisiológico. El aumento excesivo de peso y la dificultad de perderlo tras el parto suponen factores de riesgo en la aparición de complicaciones durante la gestación, el parto, la salud del feto y la futura salud de la madre (57,58).…”

Applying behavior change techniques to weight management during pregnancy: Impact on perinatal outcomes

“…Three additional trials followed the offspring of women participating in antenatal intervention trials to 6–12 months of age. 27–29 Again, no between-groups differences in infant weight were seen at follow up. Limitations of these trials included a high loss to follow up rate, 26,28 baseline differences between groups, 28,29 and minimal impact of the intervention on GWG.…”

“…27–29 Again, no between-groups differences in infant weight were seen at follow up. Limitations of these trials included a high loss to follow up rate, 26,28 baseline differences between groups, 28,29 and minimal impact of the intervention on GWG. 28 The effect of antenatal lifestyle interventions on maternal postpartum weight retention has also been under-studied.…”