Clinical trial NCT02989142: Inter-pregnAncy Coaching for a Healthy fuTure
Official title: Inter-pregnAncy Coaching for a Healthy fuTure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Pregnancy
Keywords: interpregnancy
pregnancy-induced hypertension
gestational diabetes mellitus
caesarean section
large-for-gestational-age
Lead sponsor: KU Leuven
Sponsor class: OTHER
Collaborators: name: Universiteit Antwerpen
name: UC Leuven-Limburg
First posted: 2016-12-12
Enrollment: 1100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: prevalence of participants with at least one of the following four complications: pregnancy-induced hypertension, gestational diabetes mellitus, caesarean section, large-for-gestational age baby
timeFrame: at the time of delivery 2nd pregnancy (max pregnancy duration 44 weeks)
Secondary outcomes:
measure: Drop out
timeFrame: at 6 months, at 12 months, at 18 months .... till delivery 2nd pregnancy
measure: Rate of women who returned to their pre-pregnancy weight
timeFrame: at 6 months, at 12 months, at 18 months .... till delivery 2nd pregnancy
measure: Distribution underweight, normal weight, overweight, obese BMI
timeFrame: at 6 months, at 12 months, at 18 months .... till delivery 2nd pregnancy
measure: Body composition
timeFrame: at 6 months, at 12 months, at 18 months .... till delivery 2nd pregnancy
measure: Skin fold measurements
timeFrame: at 6 months, at 12 months, at 18 months .... till delivery 2nd pregnancy
measure: Breast feeding behaviour
timeFrame: at 6 months, at 12 months, at 18 months .... till delivery 2nd pregnancy
measure: Food intake
timeFrame: at 6 months, at 12 months, at 18 months .... till delivery 2nd pregnancy
measure: Physical activity
timeFrame: at 6 months, at 12 months, at 18 months .... till delivery 2nd pregnancy
measure: Life style behaviour
timeFrame: at 6 months, at 12 months, at 18 months .... till delivery 2nd pregnancy
measure: Anxiety
timeFrame: at 6 months, at 12 months, at 18 months .... till delivery 2nd pregnancy
measure: Depression
timeFrame: at 6 months, at 12 months, at 18 months .... till delivery 2nd pregnancy
measure: rate of patients with excessive gestational weight gain during their 2nd pregnancy.
timeFrame: at the time of delivery 2nd pregnancy (max pregnancy duration 44 weeks)
measure: Rate of preterm/term pregnancies
timeFrame: at the time of delivery 2nd pregnancy (max pregnancy duration 44 weeks)
measure: Cost-effectiveness of the intervention
timeFrame: at the time of delivery 2nd pregnancy (max pregnancy duration 44 weeks)
measure: Number of women who gave at least 6 months breast feeding
timeFrame: at 6 months
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
facility: UZA
city: Antwerpen
country: Belgium
facility: Ziekenhuizen GasthuisZusters Antwerpen (GZA)
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg (ZOL)
city: Hasselt
country: Belgium
facility: Jessa ziekenhuis
city: Heusden
country: Belgium
facility: Sint-Franciskusziekenhuis
city: Leuven
country: Belgium
facility: UZ Leuven
Study officials:
affiliation: Katholieke Universiteit Leuven, Department of Development and Regeneration
name: Roland Devlieger, PhD, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.