Inter-pregnAncy Coaching for a Healthy fuTure

NCT02989142 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1100

Last updated 2017-06-12

No results posted yet for this study

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

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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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02989142 on ClinicalTrials.gov