Obesityinter-actNCT02989142
Inter-pregnAncy Coaching for a Healthy fuTure
A study testing INTER-ACT in people with Obesity and Pregnancy, run by KU Leuven at 6 sites in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- What is being tested?
- INTER-ACT
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,100 participants
- Where
- 6 sitesBelgium
- Study dates
- 1 Apr 2017to Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country.
Roland Devlieger, Phd, MD contact
6 sites in 1 country
Belgium6 sites, 6 recruiting
- Recruiting
UZA
Antwerp
- Recruiting
Ziekenhuizen GasthuisZusters Antwerpen (GZA)
Antwerp
- Recruiting
Ziekenhuis Oost-Limburg (ZOL)
Genk
- Recruiting
Jessa ziekenhuis
Hasselt
- Recruiting
Sint-Franciskusziekenhuis
Heusden
- Recruiting
UZ Leuven
Leuven
About this study
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.
Read more
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.
Read the 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.
- Being tested
- INTER-ACT
- Keywords
- interpregnancy, pregnancy-induced hypertension, gestational diabetes mellitus, caesarean section, large-for-gestational-age
- Medical subject headings
- Obesity, Hypertension, Pregnancy-Induced, Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INTER-ACTBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: INTER-ACT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at the time of delivery 2nd pregnancy (max pregnancy duration 44 weeks)
Secondary outcomes (15)
Drop out
Drop-out rate and reason for drop-out
Measured: at 6 months, at 12 months, at 18 months .... till delivery 2nd pregnancy
Rate of women who returned to their pre-pregnancy weight
Measured: at 6 months, at 12 months, at 18 months .... till delivery 2nd pregnancy
Distribution underweight, normal weight, overweight, obese BMI
Measured: at 6 months, at 12 months, at 18 months .... till delivery 2nd pregnancy
Body composition
Body composition measured by bio-electrical impedance analysis to estimate fat mass, fat free mass and muscle mass.
Measured: at 6 months, at 12 months, at 18 months .... till delivery 2nd pregnancy
Skin fold measurements
Skin fold measurements or determining body fat composition by use of a skinfold calliper.
Measured: at 6 months, at 12 months, at 18 months .... till delivery 2nd pregnancy
Breast feeding behaviour
Breast feeding (BF) habits are assessed by a structured questionnaire on breastfeeding practice. The questionnaire consists of eleven questions in Dutch, which investigates intention to BF, initiation to BF, exclusive BF, combination of bottle-feeding and BF and motives to cease BF.
Measured: at 6 months, at 12 months, at 18 months .... till delivery 2nd pregnancy
Food intake
food intake is measured by a Food Frequency Questionnaire: frequency of food intake (per day, per week or per month) and portion size (in gram or millilitre).
Measured: at 6 months, at 12 months, at 18 months .... till delivery 2nd pregnancy
Physical activity
Physical activity is measured using International Physical Activity Questionnaire (IPAQ), long version.
Measured: at 6 months, at 12 months, at 18 months .... till delivery 2nd pregnancy
Life style behaviour
Life style behaviour: whether the mother is following a diet, smoking, sleep duration and quality of sleep, alcohol use (questionnaire).
Measured: at 6 months, at 12 months, at 18 months .... till delivery 2nd pregnancy
Anxiety
Anxiety symptoms are measured with the Trait Anxiety Inventory (TAI).
Measured: at 6 months, at 12 months, at 18 months .... till delivery 2nd pregnancy
Depression
Levels of depression are measured with the reliable and valid 10-item Edinburgh Postnatal Depression Scale (PDS).
Measured: at 6 months, at 12 months, at 18 months .... till delivery 2nd pregnancy
rate of patients with excessive gestational weight gain during their 2nd pregnancy.
Measured: at the time of delivery 2nd pregnancy (max pregnancy duration 44 weeks)
Rate of preterm/term pregnancies
Measured: at the time of delivery 2nd pregnancy (max pregnancy duration 44 weeks)
Cost-effectiveness of the intervention
Costs related to these complications:
- caesarean section costs 4,013€ compared to 2,909€ for a vaginal delivery, resulting in a 4,013-2,909= 1,104€ additional cost per caesarean section (Onafhankelijke Ziekenfondsen, 2012).
- Gestational diabetes has an additional cost 820 € (Danyliv et al., IADPSG 2014, Gestational Diabetes and health care cost).
- There is also the impact of gestational diabetes on the baby. Intrauterine exposure through gestational diabetes predisposes the off-spring to diabetes: yearly cost for diabetes around 5,800€ (American Diabetes Association).
- Obesity: yearly additional direct medical cost for obesity approximately 3000 € per person due to increased contacts with health care providers and hospitalisation costs (De Jonghe E and Annemans L, 2009).
The costs of the coaching sessions are based on the official nomenclature of midwives (RIZIV - Rijksinstituut voor ziekte- en invaliditeitsverzekering, Belgian institute)
Measured: at the time of delivery 2nd pregnancy (max pregnancy duration 44 weeks)
Number of women who gave at least 6 months breast feeding
Measured: at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2016 (estimated)
- Study start1 Apr 2017
- Primary completionMar 2020 (estimated)
- Study completionSep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Universiteit Antwerpen, UC Leuven-Limburg
- Responsible party
- Principal investigator, dr. Annick Bogaerts, KU Leuven
- Investigators
- Roland Devlieger, PhD, MD, Study chair, Katholieke Universiteit Leuven, Department of Development and Regeneration
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02989142
- Sponsor's protocol ID
- T005116N
- Acronym
- inter-act
- Status last verified
- Jun 2017
- First submitted
- 29 Aug 2016
- Last updated
- 12 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Duizer L, Geusens F, Geerits E, Devlieger R, Bogaerts A. Application Usability, Engagement, and Postpartum Weight Retention: Secondary Analysis of the INTER-ACT Randomized Controlled Trial. Mayo Clin Proc Digit Health. 2026 Jun 9;4(3):100381. doi: 10.1016/j.mcpdig.2026.100381. eCollection 2026 Sep.
PubMed 42441015Van 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.
PubMed 37506163Van 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.
PubMed 36309119Bijlholt 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.
PubMed 33919758Bogaerts 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.
PubMed 28549455
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inter-pregnAncy Coaching for a Healthy fuTure
- ClinicalTrials.gov ID
- NCT02989142
- Acronym / sponsor ID
- inter-act / T005116N
- Keywords
- interpregnancy, pregnancy-induced hypertension, gestational diabetes mellitus, caesarean section, large-for-gestational-age
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,100 participants (estimated)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Collaborators
- Universiteit Antwerpen, UC Leuven-Limburg
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- Mar 2020 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 12 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control arm | No intervention | –No intervention |
| INTER-ACT arm | Experimental | Behavioral: INTER-ACTFour 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INTER-ACTPre-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. | Behavioural | INTER-ACT arm |
Primary outcome
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
Time frame: at the time of delivery 2nd pregnancy (max pregnancy duration 44 weeks)
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.
15 secondary outcomes
Drop out
Time frame: at 6 months, at 12 months, at 18 months .... till delivery 2nd pregnancy
Rate of women who returned to their pre-pregnancy weight
Time frame: at 6 months, at 12 months, at 18 months .... till delivery 2nd pregnancy
Distribution underweight, normal weight, overweight, obese BMI
Time frame: at 6 months, at 12 months, at 18 months .... till delivery 2nd pregnancy
Body composition
Time frame: at 6 months, at 12 months, at 18 months .... till delivery 2nd pregnancy
Skin fold measurements
Time frame: at 6 months, at 12 months, at 18 months .... till delivery 2nd pregnancy
Breast feeding behaviour
Time frame: at 6 months, at 12 months, at 18 months .... till delivery 2nd pregnancy
Food intake
Time frame: at 6 months, at 12 months, at 18 months .... till delivery 2nd pregnancy
Physical activity
Time frame: at 6 months, at 12 months, at 18 months .... till delivery 2nd pregnancy
Life style behaviour
Time frame: at 6 months, at 12 months, at 18 months .... till delivery 2nd pregnancy
Anxiety
Time frame: at 6 months, at 12 months, at 18 months .... till delivery 2nd pregnancy
Depression
Time frame: at 6 months, at 12 months, at 18 months .... till delivery 2nd pregnancy
rate of patients with excessive gestational weight gain during their 2nd pregnancy.
Time frame: at the time of delivery 2nd pregnancy (max pregnancy duration 44 weeks)
Rate of preterm/term pregnancies
Time frame: at the time of delivery 2nd pregnancy (max pregnancy duration 44 weeks)
Cost-effectiveness of the intervention
Time frame: at the time of delivery 2nd pregnancy (max pregnancy duration 44 weeks)
Number of women who gave at least 6 months breast feeding
Time frame: at 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2017.
- Derived from this study: PubMed 42441015Duizer L, Geusens F, Geerits E, Devlieger R, Bogaerts A. Application Usability, Engagement, and Postpartum Weight Retention: Secondary Analysis of the INTER-ACT Randomized Controlled Trial. Mayo Clin Proc Digit Health. 2026 Jun 9;4(3):100381. doi: 10.1016/j.mcpdig.2026.100381. eCollection 2026 Sep.
- Derived from this study: PubMed 37506163Van 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.
- Derived from this study: PubMed 36309119Van 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.
- Derived from this study: PubMed 33919758Bijlholt 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.
- Derived from this study: PubMed 28549455Bogaerts 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roland Devlieger, Phd, MD contact
Roland Devlieger, PhD, MD study chair
Katholieke Universiteit Leuven, Department of Development and Regeneration
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing INTER-ACT in people with Obesity and Pregnancy, run by KU Leuven at 6 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Annick Bogaerts, PhD (++3216342810, annick.bogaerts@ucll.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: at the time of delivery 2nd pregnancy (max pregnancy duration 44 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02989142, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2017.