A lifestyle intervention to reduce gestational weight gain and smoking in pregnant women to prevent perinatal morbidity

The negative perinatal consequences of obesity and smoking during and after
pregnancy for mothers and children are significant. Examples of these negative
consequences are a higher risk of dysmaturity, prematurity, gestational
diabetes mellitus, pregnancy induced hypertension and caesarean delivery.
Furthermore, the offspring has a higher chance on asthma, obesity and metabolic
abberations in childhood, progressing in adulthood. Therefore, it is important
to break the vicious circle of transferring harmful lifestyle influences from
generation to generation. However, it is unknown what the right time span is in
the period around pregnancy to start with a lifestyle intervention. Previous
studies have shown that a lifestyle intervention started after approximately
12-16 weeks of gestational age is insufficient to improve perinatal outcomes.
For the effecitiveness of a lifestyle intervention started before 12 weeks of
gestational age is insufficient evidence available. Therefore, we offer women
who are pregnant before 12 weeks of gestational age a lifestyle intervention
and we evaluate the effect of the lifestyle intervention in the current study.

The overall aim is to study the effects of a lifestyle intervention for young
women who are pregnant <= 12 weeks of gestational age and have a high risk on
perinatal morbidity because of prepregnancy overweight or obesity and, if
applicable, smoking on weight, lifestyle habits, perinatal morbidity, maternal
body composition, epigenetics, breast milk composition, metabolic and
cardiovascular markers in mother and child, microbial flora of mother and child
and lung function of the child.

Non-randomised intervention study with a pre-postdesign. All women included in
this study will participate in the lifestyle intervention.

The investigational treatment consists of a lifestyle intervention and will
directed towards a healthy diet, adequate physical activity and, if applicable,
smoking cessation. The program will start with a personal screening of the
women at the website of Slimmer Zwanger. The women receive information about
their unhealthy and healthy lifestyle habits, making visible with a figure and
supporting text. Thereafter, the coaching part of Slimmer Zwanger will start.
Through digital posts, women will get tips, tricks, rewards and recipes for
healthy meals. The advices are customised according to the results of the
personal screening and are offered at least three times a week. The lifestyle
intervention regarding a healthy diet and adequate physical activity can
consist of different components. First, women can participate in the program of
the Centre for Obesity and eating disorders Europe (CO-EUR). CO-EUR is a
second-line mental health institution and is specialised in treatment of
patients with obesity and eating disorders and their related comorbidities. The
treatment of CO-EUR is based on evidence based treatment methods. The short
program (4 months of duration) will be offered to the women participating in
this study. Furthermore, the lifestyle intervention will consist of specific
lifestyle advices during different phases of their life (during pregnancy and
postpartum). The lifestyle intervention targeted at overweight and obesity is
based on the recommendations of the CBO guideline *Diagnostics and treatment of
obesity in adults and children* and consists of a structured lifestyle program
targeted at: - Changing the dietary pattern; - Stimulating physical activity of
moderate intensity; - Self-monitoring; - Involvement of the partner. Each women
will have her personal lifestyle coach. This personal coach will have an
overview over the lifestyle intervention and guide the women through their
personal program. Moreover, this personal coach is involved with the smoking
cessation coaching if smoking is present at inclusion. Smoking cessation will
be stimulated by coaching of the website of Slimmer Zwanger. Moreover, the
personal coach will stimulate the women to stop smoking by direct feedback by
use of carbon monoxide (CO)-measurements. The CO-gauger will show the CO
concentration in the blood of the foetus as well.

For the women, there are no associated risks in this study and the intervention
is non-invasive. The lifestyle intervention will be performed according to the
current guidelines and are under stringent supervision. Women will visit the
hospital, CO-EUR or sport activities on a regular basis. This requires time and
effort of the women. To limit the burden as much as possible, the activities
will be adapted as much as possible to work and other activities of the women.
Participating women will attend the clinic for 11-12 extra visits in order to
improve lifestyle, this will take around 8 hours. Moreover, they will
participate in a physical activity program, 1 time a week (1 hour). Women
should adapt their lifestyle in order to achieve a healthier lifestyle. This
will entail a certain degree of effort. Subjects are more likely to benefit
from this research. The intervention could have beneficial effects for the
study population like improving their health status and inducing less pregnancy
and delivery complications. Finally, at the long term the global public health
will benefit as well. Data that will be collected, consisted of questionnaires
(TFEQ, EQ-5D-5L, Baecke questionnaire and smoking behaviour), measurements of
weight, anthropometry, blood pressure, CO measurements (11-12 times), body
composition (3 times), glucose, insulin, lipid profile and liver enzymes (6
times), OGTT (3 times), PWV and retinal image (5 times) and urine cotinine (6
times) in the mother. Furthermore, samples of microbial flora (faeces, vaginal
swab and throat swab) will be collected each 3 months and samples of breast
milk will be collected 1 time. The health risks of most of the measurements are
considered as negligible, since the methods are routinely used in both research
and in clinical practice. Sampling of a vaginal swab and breast milk will take
place. Taking these samples are considered to be minimal invasive, but can
bound up with some burdens for the women.

The intervention and measurements will take place mainly in the mother during
the study. However, a part of the intervention is targeted on the child and a
couple of measurements will be executed in the children. The part of the
intervention that is targeted on the child will exists of advices to the
parents among nutrition and physical activity for their child. Examples of
these advices are the introduction of solid food and sufficient physical
activity. In usual care, these advices are already implemented in the child
well being centers. However, these advices will be reinforced within the
lifestyle intervention. The child will not be exposed to risks. In which way
parents adhere to these advices will be monitored by a feeding and activity
diary. Moreover, in all children a couple of measurements will be executed. In
general, these measurements are considered as a minimal burden and the health
risks are negligible. In the children, data collection will consist of 2 times
a blood sample (of which 1 time is taken from the cord blood), measurement of
the endothelial-dependent vasodilatation and lung function and collection of
the microbial flora (faeces and throat swab) for 2 times. We believe that the
burden of the measurements will be compensated by the social interest of the
outcome of these measurements. With these measurements we can study the effects
of the degree of gestational weight gain and/or smoking reduction on the health
of the mother and child. Moreover, with the data that will be collected, more
insight into the causes and relationships between the transition of harmful
lifestyle influences and the development of non-communicable diseases will be
derived. The lifestyle intervention is set up in that way, that implementation
in usual care would be very easy. When the lifestyle intervention will turn out
to be effective, this can be easy implemented in the already existing health
care. With this in mind, this study will contribute to the global public
health. Namely, not only the health of the mother will improve, but also the
health of the child will be guaranteed by an intervention that break the
vicious circle of transferring harmful lifestyle influences from generation to
generation.