Optimizing periconceptional lifestyle of overweight women using a blended personalized care intervention combining eHealth and Face-to-face coUnSEling: The Randomized Controlled eFUSE Trial

The eFUSE study will evaluate an innovative blended lifestyle care intervention combined with psychological therapy to improve periconceptional lifestyle behaviors in overweight women using an RCT. The intervention group will be provided with a blended care approach, including three face-to-face counseling sessions, and access to the periconception eHealth lifestyle care platform ‘Smarter Pregnancy’ and mobile health application Headspace. In the face-to-face counseling sessions motivational interviewing will be used and components of cognitive behavioral therapy, acceptance and commitment therapy and mindfulness will be practiced. The control group will receive standard care, which comprises of one face-to-face counseling session and access to the periconception eHealth lifestyle care platform ‘Smarter Pregnancy’.
Especially the addition of components of several psychological therapies to a proven effective blended care approach is new and might result in a powerful measure to improve parental lifestyle behaviors before and during pregnancy. We hypothesize that the two additional face-to-face counseling sessions, in which several psychological techniques will be practiced, will support the participating patient-couples towards a significant and more sustainable lifestyle change. Moreover, we expect that the effects of the face-to-face sessions and eHealth program reinforce each other. By choosing a proximal primary outcome measure, namely the Lifestyle Risk Score, we aim to assess the effects directly influenced by the intervention, so that the results can be clearly deduced from the content of our approach.

We hypothesize that two additional face-to-face counseling sessions, in which several psychological techniques will be practiced, will support the participating patient-couples towards a significant and more sustainable lifestyle change compared with the control group.

6 weeks, 12 weeks, 18 weeks, 24 weeks after start of intervention/control condition

Blended personalized periconception lifestyle approach, consisting of:
1. A periconception eHealth platform, providing personalized risk assessment and nutrition and lifestyle counselling via the evidence-based eHealth interventions ‘Preparing for Pregnancy’ (www.zwangerwijzer.nl) and ‘Smarter Pregnancy’ (www.slimmerzwanger.nl).
2. Three face-to-face lifestyle counselling sessions, provided by trained eFUSE counsellors, as previously practiced in the (proven effective) outpatient antenatal clinic ‘Achieving a Healthy Pregnancy’.In the intervention group, the blended care approach will be offered next to care as usual in accordance with the national guidelines. All elements offered in the blended care approach are personalized tot the individual patient-couple, based on the results of the risk assessment and lifestyle questionnaires filled out on the eHealth platform.