Inter-pregnAncy Coaching for a Healthy fuTure

NCT ID: NCT02989142

Last Updated: 2017-06-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 1100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-01
• Study Completion Date: 2020-09-30

Brief 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.

Detailed Description

The aim is to decrease the prevalence of pregnancy and birth-related complications (pregnancy-induced hypertension (PIH), gestational diabetes mellitus (GDM), caesarean section (CS), and large-for-gestational-age babies (LGA)). These complications occur in 26% of pregnancies with normal start BMI and adequate weight gain, in 34% in normal start BMI but excessive gestational weight gain and in up to 66% in obese class III (BMI≥40kg/m²) combined with excessive gestational weight gain. Moreover, as the prevalence of maternal obesity continues to rise, increasing numbers of children are exposed to an 'obesogenic intrauterine environment'. Obesity in pregnancy has therefore the potential to result in an 'intergenerational cycle' of obesity through in utero programming.

The investigators focus on women with excessive weight gain during their 1st pregnancy as currently, half of them do not return to their pre-pregnancy weight before the next pregnancy. This results in a complication rate as high as 42% (PIH, GDM, CS, LGA). The investigators target a healthy BMI at start of pregnancy by intervening during the pre-conception period- and an adequate weight gain during pregnancy by intervening during pregnancy in these women. The intervention will be evaluated in a randomized controlled trial including 1,100 women.

The proposed intervention combines face-to-face coaching with the use of a mobile App (so-called 'inter-act' app) connected to medical devices (scale and pedometer). The app monitors women's weight, eating behaviour, physical activity, mental wellbeing, and provides continuously coaching through positive behavioral change techniques. The 'inter-act' App covers after the 1st delivery breast-feeding support, while during pregnancy, the gestational weight gain guidelines of the Institute of Medicine (IOM) are included.

Drop out of less motivated women is avoided as the time points of the four pre-conception coaching sessions coincide with the existing postnatal follow-up visits for neonates (Governmental vaccination scheme through the organisation " Kind & Gezin"), and the three pregnancy coaching sessions coincide with the three routine ultrasound scans during normal pregnancy (KCE Guidelines).

Each year, there are 8,900 singleton pregnancies in Flanders in whom the mother had excessive gestational weight gain in the prior pregnancy. The current rate of at least one of the four major pregnancy and birth-related complications (PIH, GDM, CS, LGA) in the 8,900 pregnancies is 42%. If the complications rate reduces with 1/4, this involves more than 900 pregnancies, and reduces costs related to caesarean sections, gestational diabetes, obesity in mother & child.

Conditions

Obesity; Pregnancy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Control arm

No intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

INTER-ACT arm

Four pre-conception coaching sessions : postpartum week 6, week 8, week 12, 6 months.

Three pregnancy coaching sessions: at the time of the planned ultrasound scans.

Group Type: EXPERIMENTAL

INTER-ACT

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Excessive weight gain during their previous pregnancy (above the IOM recommendations)
• Child wish for having a next pregnancy
• Women aged 18 years or more
• Sufficient fluent in Dutch language
• Able to give written informed consent
• Able to use a smartphone. If the women do not have a smartphone because of socio-economic reasons, a smartphone is at her disposal for the whole duration of the intervention, in order to be able to use Apps connected with a Bluetooth pedometer and balance scale.

Exclusion Criteria

• Requirement for (complex) diets
• History of or a plan for bariatric surgery
• Underlying or chronic disorders (e.g. diabetes, thyroid disease, renal diseases)
• Significant psychiatric disorder
• Previous still birth

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Universiteit Antwerpen

OTHER

Sponsor Role: collaborator

UC Leuven-Limburg

UNKNOWN

Sponsor Role: collaborator

KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

dr. Annick Bogaerts

Prof. dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Roland Devlieger, PhD, MD

Role: STUDY_CHAIR

Katholieke Universiteit Leuven, Department of Development and Regeneration

Locations

UZA

Antwerp, , Belgium

Site Status: RECRUITING

Ziekenhuizen GasthuisZusters Antwerpen (GZA)

Antwerp, , Belgium

Site Status: RECRUITING

Ziekenhuis Oost-Limburg (ZOL)

Genk, , Belgium

Site Status: RECRUITING

Jessa ziekenhuis

Hasselt, , Belgium

Site Status: RECRUITING

Sint-Franciskusziekenhuis

Heusden, , Belgium

Site Status: RECRUITING

UZ Leuven

Leuven, , Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Annick Bogaerts, PhD

Role: CONTACT

annick.bogaerts@ucll.be

++3216342810

Roland Devlieger, Phd, MD

Role: CONTACT

Roland.Devlieger@med.kuleuven.be

References

Van Uytsel H, Ameye L, Devlieger R, Bijlholt M, Van der Gucht K, Jacquemyn Y, Bogaerts A. Effect of the INTER-ACT lifestyle intervention on maternal mental health during the first year after childbirth: A randomized controlled trial. PLoS One. 2023 Jul 28;18(7):e0284770. doi: 10.1371/journal.pone.0284770. eCollection 2023.

Reference Type: DERIVED

PMID: 37506163 (View on PubMed)

Van Uytsel H, Bijlholt M, Devlieger R, Ameye L, Jochems L, van Holsbeke C, Schreurs A, Catry V, Bogaerts A. Effect of the e-health supported INTER-ACT lifestyle intervention on postpartum weight retention and body composition, and associations with lifestyle behavior: A randomized controlled trial. Prev Med. 2022 Nov;164:107321. doi: 10.1016/j.ypmed.2022.107321. Epub 2022 Oct 27.

Reference Type: DERIVED

PMID: 36309119 (View on PubMed)

Bijlholt M, Ameye L, Van Uytsel H, Devlieger R, Bogaerts A. The INTER-ACT E-Health Supported Lifestyle Intervention Improves Postpartum Food Intake and Eating Behavior, but Not Physical Activity and Sedentary Behavior-A Randomized Controlled Trial. Nutrients. 2021 Apr 14;13(4):1287. doi: 10.3390/nu13041287.

Reference Type: DERIVED

PMID: 33919758 (View on PubMed)

Bogaerts A, Ameye L, Bijlholt M, Amuli K, Heynickx D, Devlieger R. INTER-ACT: prevention of pregnancy complications through an e-health driven interpregnancy lifestyle intervention - study protocol of a multicentre randomised controlled trial. BMC Pregnancy Childbirth. 2017 May 26;17(1):154. doi: 10.1186/s12884-017-1336-2.

Reference Type: DERIVED

PMID: 28549455 (View on PubMed)

Other Identifiers

T005116N

Identifier Type: -

Identifier Source: org_study_id