Twin Pregnancy, DichorionicLIFETWINNCT07270640
Lifestyle Intervention to Improve Twin Pregnancy Outcomes
A study testing LIFETWIN in people with Twin Pregnancy, Dichorionic, run by Universitaire Ziekenhuizen KU Leuven at 4 sites in Belgium.
Trial summary
The goal of this clinical trial to is assess the benefits of holistic lifestyle interventions, including nutrition, physical activities, and mindfulness, aiming to reduce preterm birth in twins, potentially revolutionizing twin care globally. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Twin Pregnancy, Dichorionic
- What is being tested?
- LIFETWIN
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 4 sitesBelgium
- Study dates
- 5 Dec 2025to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Prior to any randomization or intervention, participants must have provided voluntary written informed consent.
- Diagnosis of dichorionic twin pregnancies must align with the acceptance criteria.
- Participants must be recruited before the 14th week of gestation.
- Proficiency in Dutch, English, or French is required.-
Who cannot join
- Participant has a history of pre-existing diseases or condition impacting their diet:
- pre-gestational diabetes
- severe heart disease,
- chronic renal disease,
- celiac disease,
- inflammatory bowel disease,
Show all 32Show fewer
- post-bariatric surgery
- Participant has a history of pre-existing diseases or conditions impacting their physical activity ability:
- Chronic Obstructive Pulmonary Disease (COPD)
- Severe Asthma.
- Fibromyalgia
- Osteoarthritis
- Chronic Pain Syndromes
- Spinal Cord Injuries.
- Multiple Sclerosis (MS)
- Parkinson's Disease
- History of a Stroke
- Drug resistance Epilepsy
- Participants identified with mental vulnerabilities requiring specific care pathways by Born in Belgium (BIB) or local screening tool.
- Participants with a History of Mental Health Disorders
- Post-Traumatic Stress Disorder (PTSD)
- Anxiety Disorders
- Depressive Disorders
- Bipolar Disorder
- Obsessive-Compulsive Disorder (OCD)
- Schizophrenia or schizoaffective disorder
- Inability to give informed consent
- No knowledge of Dutch, English or French
- First trimester diagnosis of severe congenital anomaly in one or both twins
- First trimester foetal demise of one or both twins
- Rupture of membranes prior to recruitment
- Participation in any other interventional Study
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium4 sites, 4 recruiting
- Recruiting
CHU Brugmann
Brussels, 1020
Jacques Jani, MD, PhD, +3216344200, lifetwin@uzleuven.be
Jacques Jani, MD, PhD
- Recruiting
Ziekenhuis Oost-Limburg
Genk, 3600
Dr. Tinne Mesens, +3216344200, lifetwin@uzleuven.be
Tinne Mesens, MD
- Recruiting
UZ Leuven
Leuven, 3000
Prof. Dr. Roland Devlieger, +3216344200, lifetwin@uzleuven.be
Roland Devlieger, MD, PhD
- Recruiting
Hôpital de la Citadelle
Liège, 4000
Laure Noël, MD, +3216344200, lifetwin@uzleuven.be
Laure Noël, MD
About this study
Official title: Lifestyle Intervention to Improve Twin Pregnancy Outcomes: an Integrated Pilot Study for a Multicentric Randomized Controlled Trial
The goal of this clinical trial to is assess the benefits of holistic lifestyle interventions, including nutrition, physical activities, and mindfulness, aiming to reduce preterm birth in twins, potentially revolutionizing twin care globally.
An initial integrated pilot study is be conducted to assess and refine the intervention methods. The primary objective of the pilot study is to evaluate feasibility. If deemed feasible, the full study will be implemented, incorporating data from pilot study participants into the main study.
Read more
Objective of the full study: To evaluate if a multi-component lifestyle extends gestational age at delivery by one week. Additional objective: to evaluate if the intervention positively influences multiple secondary outcomes including pregnancy complications, neonatal and maternal outcomes, and maternal quality of life.
For the pilot study, we aim to include 81 pregnant women across 4 sites. This sample size is based on pragmatic considerations, while ensuring diverse representation, including individuals from low socioeconomic status backgrounds and high-risk groups. For the full trial, in total 274 women are needed to detect a clinically meaningful difference in gestational age at delivery, the primary outcome.
- Conditions
- Twin Pregnancy, Dichorionic
- Being tested
- LIFETWIN
- Keywords
- twin pregnancy, dichorionic, lifestyle interventions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LIFETWINBehavioural
The LIFETWIN intervention provides 8 coaching sessions to women during pregnancy, focusing on nutrition (including multivitamin intake), physical activity and stress reduction.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Lifestyle coaching sessions Receives: Behavioral: LIFETWIN |
| Control | No intervention | Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gestational age at delivery (main)
The primary outcome is gestational age at delivery, measured in weeks and days. This is calculated based on the last menstrual period and confirmed via early ultrasound dating (before 13 weeks and 6 days) for spontaneous pregnancies or based on embryo age at transfer for IVF patients. The study aims to evaluate whether a multi-component lifestyle intervention can delay delivery by at least one week, thereby enhancing pregnancy outcomes. Gestational age data will be collected from medical records to ensure accuracy and consistency.
Measured: Delivery
Secondary outcomes (12)
Birth weight (main)
Birth weight in grams and percentile.
Measured: Delivery
Small for gestational age (main)
Small for gestational age in at least one twin, defined as below the 10th percentile according to twins' nomograms
Measured: Delivery
Offspring mortality (main)
Offspring mortality- defined as the death of one or both twins occurring at any time from foetal viability (24 weeks' gestation) until 28 days postpartum (neonatal period).
Measured: 24 weeks -28 days postpartum
Offspring infection (main)
Offspring infection- defined as neonatal sepsis, congenital pneumonia, neonatal meningitis, or necrotizing enterocolitis (NEC) with infection within the first 72 hours of delivery.
Measured: within the first 72 hours of delivery
Early neurodevelopmental morbidity (main)
Early neurodevelopmental morbidity- defined as diagnosis of Intraventricular haemorrhage (IVH) Grade III-IV, periventricular leukomalacia (PVL), hypoxic-ischemic encephalopathy (HIE), and neonatal seizures.
Measured: 6 weeks postpartum
Gastrointestinal morbidity (main)
Gastrointestinal morbidity- defined as diagnosis of NEC and spontaneous perforation.
Measured: 6 weeks postpartum
Respiratory morbidity (main)
Respiratory morbidity- defined as diagnosis of respiratory distress syndrome (RDS), bronchopulmonary dysplasia (BPD), transient tachypnoea of the newborn (TTN) or persistent pulmonary hypertension of the newborn (PPHN)
Measured: 6 weeks postpartum
NICU admission (main)
Any admission to the Neonatal intensive care unit (NICU) within 72 hours of delivery.
Measured: within 72 hours of delivery
Number of days in the NICU (main)
Number of days in the NICU
Measured: 6 weeks postpartum
Gestational weight gain (main)
Gestational Weight Gain (GWG) corrected to pregnancy duration.
Measured: from 14 weeks pregnancy to delivery
Maternal quality of life (main)
Maternal quality of Life based on questionnaire EQ-5D-5L.
Measured: Before 14 weeks of pregnancy, 32-34 weeks and 6 weeks postpartum
Postpartum weight (main)
Postpartum weight recorded 6 weeks postpartum
Measured: 6 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2025
- Study start5 Dec 2025
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Twin Pregnancy, DichorionicStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- 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
- Model description
- First, a pilot phase (n = 81) is installed to evaluate feasibility. After evaluation and if necessary protocol amendments, a full trial will be rolled out (n = 274)
- Masking
- None (open label)
- Enrolment
- 81 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07270640
- Sponsor's protocol ID
- S68251
- Acronym
- LIFETWIN
- Status last verified
- Oct 2025
- First submitted
- 18 Nov 2025
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The datasets generated and/or analysed during the current study will be made available upon completion of the LIFETWIN study project. De-identified research data, together with accompanying metadata and relevant documentation, will be deposited in the KU Leuven Research Data Repository (RDR) and will be accessible in accordance with institutional policies and applicable legal and ethical requirements. Data sharing will occur after publication of the main study results and following the end of the project, subject to protection of participant confidentiality and compliance with the informed consent procedures approved by the relevant ethics committee.
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lifestyle Intervention to Improve Twin Pregnancy Outcomes: an Integrated Pilot Study for a Multicentric Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07270640
- Acronym / sponsor ID
- LIFETWIN / S68251
- Conditions
- Twin Pregnancy, Dichorionic
- Keywords
- twin pregnancy, dichorionic, lifestyle interventions
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 81 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 5 Dec 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 8 Dec 2025 (actual)
- 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 goal of this clinical trial to is assess the benefits of holistic lifestyle interventions, including nutrition, physical activities, and mindfulness, aiming to reduce preterm birth in twins, potentially revolutionizing twin care globally.
An initial integrated pilot study is be conducted to assess and refine the intervention methods. The primary objective of the pilot study is to evaluate feasibility. If deemed feasible, the full study will be implemented, incorporating data from pilot study participants into the main study.
Objective of the full study: To evaluate if a multi-component lifestyle extends gestational age at delivery by one week. Additional objective: to evaluate if the intervention positively influences multiple secondary outcomes including pregnancy complications, neonatal and maternal outcomes, and maternal quality of life.
For the pilot study, we aim to include 81 pregnant women across 4 sites. This sample size is based on pragmatic considerations, while ensuring diverse representation, including individuals from low socioeconomic status backgrounds and high-risk groups. For the full trial, in total 274 women are needed to detect a clinically meaningful difference in gestational age at delivery, the primary outcome.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- First, a pilot phase (n = 81) is installed to evaluate feasibility. After evaluation and if necessary protocol amendments, a full trial will be rolled out (n = 274)
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: LIFETWINLifestyle coaching sessions |
| Control | No intervention | –Standard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Prior to any randomization or intervention, participants must have provided voluntary written informed consent.
- Diagnosis of dichorionic twin pregnancies must align with the acceptance criteria.
- Participants must be recruited before the 14th week of gestation.
- Proficiency in Dutch, English, or French is required.-
Key exclusion criteria (32 listed)
- Participant has a history of pre-existing diseases or condition impacting their diet:
- Participant has a history of pre-existing diseases or conditions impacting their physical activity ability:
- Participants identified with mental vulnerabilities requiring specific care pathways by Born in Belgium (BIB) or local screening tool.
- Participants with a History of Mental Health Disorders
- Inability to give informed consent
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 |
|---|---|---|
| LIFETWINThe LIFETWIN intervention provides 8 coaching sessions to women during pregnancy, focusing on nutrition (including multivitamin intake), physical activity and stress reduction. | Behavioural | Intervention |
Primary outcome
Gestational age at delivery (main)
Time frame: Delivery
The primary outcome is gestational age at delivery, measured in weeks and days. This is calculated based on the last menstrual period and confirmed via early ultrasound dating (before 13 weeks and 6 days) for spontaneous pregnancies or based on embryo age at transfer for IVF patients. The study aims to evaluate whether a multi-component lifestyle intervention can delay delivery by at least one week, thereby enhancing pregnancy outcomes. Gestational age data will be collected from medical records to ensure accuracy and consistency.
12 secondary outcomes
Birth weight (main)
Time frame: Delivery
Small for gestational age (main)
Time frame: Delivery
Offspring mortality (main)
Time frame: 24 weeks -28 days postpartum
Offspring infection (main)
Time frame: within the first 72 hours of delivery
Early neurodevelopmental morbidity (main)
Time frame: 6 weeks postpartum
Gastrointestinal morbidity (main)
Time frame: 6 weeks postpartum
Respiratory morbidity (main)
Time frame: 6 weeks postpartum
NICU admission (main)
Time frame: within 72 hours of delivery
Number of days in the NICU (main)
Time frame: 6 weeks postpartum
Gestational weight gain (main)
Time frame: from 14 weeks pregnancy to delivery
Maternal quality of life (main)
Time frame: Before 14 weeks of pregnancy, 32-34 weeks and 6 weeks postpartum
Postpartum weight (main)
Time frame: 6 weeks postpartum
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Individual participant dataSharing planned: Yes. The datasets generated and/or analysed during the current study will be made available upon completion of the LIFETWIN study project. De-identified research data, together with accompanying metadata and relevant documentation, will be deposited in the KU Leuven Research Data Repository (RDR) and will be accessible in accordance with institutional policies and applicable legal and ethical requirements. Data sharing will occur after publication of the main study results and following the end of the project, subject to protection of participant confidentiality and compliance with the informed consent procedures approved by the relevant ethics committee.
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LIFETWIN in people with Twin Pregnancy, Dichorionic, run by Universitaire Ziekenhuizen KU Leuven at 4 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 4 inclusion and 32 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: looking for participants now, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Prof. Dr. Roland Devlieger (+3216344200, lifetwin@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gestational age at delivery (main) (time frame: Delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Aug 2026.