DALI: Lifestyle pilot

Gestational Diabetes (GDM) is defined as 'carbohydrate intolerance resulting in
hyperglycaemia of variable severity with onset or first recognition during
pregnancy'. The prevalence of GDM in Europe is reported to vary considerably,
in some populations GDM occurs already in up to 20 % of all pregnancies. There
are few published studies about preventing GDM.

The overall aim of the DALI study is to identify the best available measures to
prevent GDM in an ongoing pregnancy, to provide a cost-benefit calculation of
GDM prevention for health care systems, and to establish a pan-European cohort
of mother-offspring pairs for future analyses with a central biobank and data
base. For this purpose, a randomised controlled trial will be conducted in 10
European countries. In this pilot study, the lifestyle interventions and
measurement procedures will be tested in 12 women in each country.

Twelve women will be recruited at each site: 4 randomised to each of the
lifestyle interventions that have been developed: Physical activity, diet and
both physical activity and diet. Women will be followed up for approximately 7
months, from 12 weeks to delivery. This will be a full test of the main trial,
using all planned materials and methods.

In the programme, one-to-one contact will be offered, along with telephone
booster calls. The same amount of time will be offered to each participant
during the trial. The intervention will be provided in five sessions of
approximately 30-45 minutes, and in four telephone calls of approximately 20
minutes. The on-to-one sessions will take place at the home of the participants
or in hospital/midwife practice/general practice, depending on cultural
acceptability of home visits.
To optimize rapport, it is expected that a lifestyle coach is made responsible
for supporting a defined number of participants throughout the pregnancy
period. The coach will have a PDA which will provide the framework for the
visit and will help steer the coach to deliver the nutrition and/or physical
activity package. Details will be entered into the PDA programme and at the end
of the session, the synchronization button will be pressed to send the recorded
data to the Trial coordination team.

* Physical activity
According to the ACOG guidelines, pregnant women are recommended to be
moderately physically active for at least 30 minutes per day on at least 5 days
of the week [13]. Given our population of obese women, low fitness and physical
activity levels are to be expected. Activities such as swimming, walking and
cycling are activities that the participants should be able to undertake during
the course of their pregnancy. As pregnancy progresses through the third
trimester, physical activity may decrease and this needs to be managed
sympathetically, providing e.g. sitting and/or upper limb exercises as
alternatives. They are advised to (1) incorporate active movement as much as
possible into their daily life (e.g. by parking further away from destination),
(2) reduce sedentary time, (3) incorporate upper and or lower limb resistance
exercise as physical activity, (4) to increase the number of steps taken per
day and (5) to be more active during the weekends. An action plan for
increasing physical activity levels will be made during the first session, and
evaluated in subsequent sessions. Participants will receive pedometers for
feedback on their behaviour and progress.

* Diet
The following dietary objectives will be set for each participant to achieve or
to maintain: (1) to reduce intake of sugary drinks (replace with water), (2) to
eat more non-starchy vegetables, (3) to choose high-fibre, over low fibre
products (*5 g fibre/100 g), (4) to watch portion size, (5) to increase intake
of proteins (e.g. meat, fish, beans), (6) to reduce fat intake (e.g. snack,
candy, fast food, fried foods), and (7) to reduce intake of carbohydrates (e.g.
potatoes, pasta, rice, snacks, candy) . An action plan for improving dietary
behaviour will be made during the first session, and evaluated in subsequent
sessions.

Coaches
Members of the research team will carry out the face-to-face counselling and
the telephone booster sessions. They will receive a special training programme
containing motivational interviewing techniques to overcome the ambivalence or
barriers that keeps people from making desired lifestyle changes in their
lives.

Risks and burden for the participant.
* Measurements
There are 3 moments of measurement in 6-7 months. The measurements consist of:
blood samples (including OGTT), ultrasound, body weight measurement, wearing an
accelerometer and filling out questionnaires about lifestyle and demographics.
Height will be measured at baseline. In addition, at delivery a blood sample
from the mother will be taken.

Most measurements can be performed shortly after the visit with the
obstetrician, so it will not take extra time to come to the hospital for the
measurement. The measurements will take about 30 minutes extra. At two points
in time there will be an extra OGTT for this study. The OGTT will take 2.5
hours. Venesection does have a risk of bruising and discomfort, but no risk of
serious harm.

* Interventions
The women will be asked to engage either physical activity, diet, or the
combination thereof.

Potential risks of physical activity will be minimized by following the
exercise-during-pregnancy- guidelines of the ACOG. In the event of an injury
due to physical activity or of pregnancy complications, participants will be
advised to consult their treating clinician (obstetrician or midwife)
respectively.

Potential risk of diet include starvation ketogenesis. However, women will not
be advised to severely restrict energy intake, but will be advised to eat
different food products (eg whole grain bread instead of white bread). However,
to check for starvation ketogenesis, 3-Beta Hydroxy-butyrate will be one of the
monitored parameters.

Benefits
It is believed that the potential risks mentioned above are minimal, relative
to the anticipated benefits. The women in this study are at risk for
gestational diabetes and all interventions aim at reducing this risk in
addition to other potential benefits (i.e. exercise improving mood and
well-being) .

Relevance for expecting mothers:
GDM is associated with an increased risk for other pregnancy complications,
such as preeclampsia, infection and postpartum haemorrhage, and an increased
risk for developing diabetes after pregnancy [14].

Relevance for children:
The prevention of GDM is also relevant for the children, since it also puts the
neonates at risk. GDM is associated with increased risk for macrosomia,
jaundice and birth trauma. Later in life, children of gestational diabetic
mothers have an increased risk for obesity, impaired glucose tolerance, and
diabetes type 2 [14].