Inter-pregnAncy Coaching for a Healthy fuTure
NCT02989142 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1100
Last updated 2017-06-12
Summary
The project focuses on prevention of major pregnancy and birth related complications : pregnancy-induced hypertension (PIH), gestational diabetes mellitus (GDM), caesarean section (CS), and large-for-gestational-age (LGA), i.e. the birth weight of the baby exceeds the 90% percentile of birth weights for the specific pregnancy duration.
The investigators focus on the pre-conception period, i.e. the pre-conception period of the 2nd pregnancy in women with an excessive weight gain during their 1st pregnancy, aiming to decrease the complications rate in their 2nd pregnancy.
Women with an excessive gestational weight gain have obtained the extra weight during a rather short period of time, e.g. 20 kilos in the last 4 or 5 months of their pregnancy. This characteristic distinguishes the target group from the general population with overweight/obesity, in whom the extra weight was acquired during many years and independent from a pregnancy, making a behaviour change more complex.
The coaching intervention combines face-to-face counselling with the use of a mobile App connected to medical devices (scale and pedometer). The app monitors important indicators (weight, eating behaviour, physical activity, mental wellbeing), provides coaching through established behavioral change techniques, and is specifically tailored for women with excessive weight gain during the previous pregnancy.
The goal is to decrease the rate of pregnancy and birth-related adverse outcomes in the next pregnancy by a healthy life style, starting shortly after their 1st delivery and sustained during the next pregnancy.
Conditions
- Obesity
- Pregnancy
Interventions
- BEHAVIORAL
-
INTER-ACT
Pre-conception coaching sessions: We encourage less motivated women to participate to the trial by collaborating with Kind \& Gezin from the very beginning, as most timepoints of the counselling sessions coincide with the time points of the Kind\&Gezin vaccine scheme (postpartum week 6, week 8, week 12, 6 months). We will organize the coaching in a "mother and baby friendly" community-based setting or in the hospitals, as preferred by the mothers. Pregnancy coaching sessions: take place in hospital, at the time of the three planned ultrasound scans. By consequence, the applied methodology can be applied as such at the moment of global utilisation in Flanders.
Sponsors & Collaborators
-
Universiteit Antwerpen
collaborator OTHER -
UC Leuven-Limburg
collaborator UNKNOWN -
KU Leuven
lead OTHER
Principal Investigators
-
Roland Devlieger, PhD, MD · Katholieke Universiteit Leuven, Department of Development and Regeneration
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 45 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-04-01
- Primary Completion
- 2020-03-31
- Completion
- 2020-09-30
Countries
- Belgium
Study Locations
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