Inter-pregnAncy Coaching for a Healthy fuTure

NCT02989142 | Unknown DMC

• 1 other identifier: T005116N
• Study Type: interventional
• Target: 1,100
• Locations: 1 country
• Sites: 6

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.

Conditions

Obesity; Pregnancy

Keywords

interpregnancy; pregnancy-induced hypertension; gestational diabetes mellitus; caesarean section; large-for-gestational-age

Outcome Measures

Primary Outcomes (1)

• 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

  The existence of pregnancy-induced hypertension and gestational diabetes mellitus are assessed during pregnancy. Whether the 2nd pregnancy results in a caesarean section and large-for-gestational-age baby will be known at the time of delivery 2nd pregnancy. Therefore, the primary outcome of prevalence of participants with pregnancy and birth-related complications is assessed at the time of delivery 2nd pregnancy.

  at the time of delivery 2nd pregnancy (max pregnancy duration 44 weeks)

Secondary Outcomes (15)

• Drop out

  at 6 months, at 12 months, at 18 months .... till delivery 2nd pregnancy

• Rate of women who returned to their pre-pregnancy weight

  at 6 months, at 12 months, at 18 months .... till delivery 2nd pregnancy

• Distribution underweight, normal weight, overweight, obese BMI

  at 6 months, at 12 months, at 18 months .... till delivery 2nd pregnancy

• Body composition

  at 6 months, at 12 months, at 18 months .... till delivery 2nd pregnancy

• Skin fold measurements

  at 6 months, at 12 months, at 18 months .... till delivery 2nd pregnancy

Study Arms (2)

Control arm

NO INTERVENTION

No intervention

INTER-ACT arm

EXPERIMENTAL

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.

Behavioral: INTER-ACT

Interventions

INTER-ACT 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.

INTER-ACT arm

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• KU Leuven: lead
• Universiteit Antwerpen: collaborator
• UC Leuven-Limburg: collaborator

Study Sites (6)

UZA

Antwerp, Belgium

RECRUITING

Ziekenhuizen GasthuisZusters Antwerpen (GZA)

Antwerp, Belgium

RECRUITING

Ziekenhuis Oost-Limburg (ZOL)

Genk, Belgium

RECRUITING

Jessa ziekenhuis

Hasselt, Belgium

RECRUITING

Sint-Franciskusziekenhuis

Heusden, Belgium

RECRUITING

UZ Leuven

Leuven, Belgium

RECRUITING

Related Publications (4)

• 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.

  PMID: 37506163 DERIVED

• 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.

  PMID: 36309119 DERIVED

• 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.

  PMID: 33919758 DERIVED

• 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.

  PMID: 28549455 DERIVED

MeSH Terms

Conditions

Obesity; Hypertension, Pregnancy-Induced; Diabetes, Gestational

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Study Officials

• Roland Devlieger, PhD, MD

  Katholieke Universiteit Leuven, Department of Development and Regeneration

  STUDY CHAIR

Central Study Contacts

Annick Bogaerts, PhD

CONTACT

++3216342810; annick.bogaerts@ucll.be

Roland Devlieger, Phd, MD

CONTACT

Roland.Devlieger@med.kuleuven.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. dr.

Study Record Dates

• First Submitted: August 29, 2016
• First Posted: December 12, 2016
• Study Start: April 1, 2017
• Primary Completion: March 1, 2020
• Study Completion: September 1, 2020
• Last Updated: June 12, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

BE (6)