Lifestyle Intervention to Improve Twin Pregnancy Outcomes (LIFETWIN)

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Twin Pregnancy, Dichorionic
• Intervention / Treatment: Behavioral: LIFETWIN

• Study Type: Interventional
• Enrollment (Estimated): 81
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Prof. Dr. Roland Devlieger; Phone Number: +3216344200; Email: lifetwin@uzleuven.be

Study Locations

• Belgium
  • Brussels, Belgium, 1020
    • Not yet recruiting
    • CHU Brugmann
    • Contact: Jacques Jani, MD, PhD; Phone Number: +3216344200; Email: lifetwin@uzleuven.be
    • Principal Investigator: Jacques Jani, MD, PhD
  • Genk, Belgium, 3600
    • Recruiting
    • Ziekenhuis Oost-Limburg
    • Contact: Dr. Tinne Mesens; Phone Number: +3216344200; Email: lifetwin@uzleuven.be
    • Principal Investigator: Tinne Mesens, MD
  • Leuven, Belgium, 3000
    • Recruiting
    • UZ Leuven
    • Principal Investigator: Roland Devlieger, MD, PhD
    • Contact: Prof. Dr. Roland Devlieger; Phone Number: +3216344200; Email: lifetwin@uzleuven.be
  • Liège, Belgium, 4000
    • Not yet recruiting
    • Hôpital de la Citadelle
    • Contact: Laure Noël, MD; Phone Number: +3216344200; Email: lifetwin@uzleuven.be
    • Principal Investigator: Laure Noël, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.-

Exclusion Criteria:

• Participant has a history of pre-existing diseases or condition impacting their diet:

  1. pre-gestational diabetes
  2. severe heart disease,
  3. chronic renal disease,
  4. celiac disease,
  5. inflammatory bowel disease,
  6. post-bariatric surgery

• Participant has a history of pre-existing diseases or conditions impacting their physical activity ability:

  1. Chronic Obstructive Pulmonary Disease (COPD)
  2. Severe Asthma.
  3. Fibromyalgia
  4. Osteoarthritis
  5. Chronic Pain Syndromes
  6. Spinal Cord Injuries.
  7. Multiple Sclerosis (MS)
  8. Parkinson's Disease
  9. History of a Stroke
  10. 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

  1. Post-Traumatic Stress Disorder (PTSD)
  2. Anxiety Disorders
  3. Depressive Disorders
  4. Bipolar Disorder
  5. Obsessive-Compulsive Disorder (OCD)
  6. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Standard of care
Experimental: Intervention; Lifestyle coaching sessions	Behavioral: LIFETWIN; The LIFETWIN intervention provides 8 coaching sessions to women during pregnancy, focusing on nutrition (including multivitamin intake), physical activity and stress reduction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gestational age at 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.	Delivery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Birth weight	Birth weight in grams and percentile.	Delivery
Small for gestational age	Small for gestational age in at least one twin, defined as below the 10th percentile according to twins' nomograms	Delivery
Offspring mortality	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).	24 weeks -28 days postpartum
Offspring infection	Offspring infection- defined as neonatal sepsis, congenital pneumonia, neonatal meningitis, or necrotizing enterocolitis (NEC) with infection within the first 72 hours of delivery.	within the first 72 hours of delivery
Early neurodevelopmental morbidity	Early neurodevelopmental morbidity- defined as diagnosis of Intraventricular haemorrhage (IVH) Grade III-IV, periventricular leukomalacia (PVL), hypoxic-ischemic encephalopathy (HIE), and neonatal seizures.	6 weeks postpartum
Gastrointestinal morbidity	Gastrointestinal morbidity- defined as diagnosis of NEC and spontaneous perforation.	6 weeks postpartum
Respiratory morbidity	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)	6 weeks postpartum
NICU admission	Any admission to the Neonatal intensive care unit (NICU) within 72 hours of delivery.	within 72 hours of delivery
Number of days in the NICU	Number of days in the NICU	6 weeks postpartum
Gestational weight gain	Gestational Weight Gain (GWG) corrected to pregnancy duration.	from 14 weeks pregnancy to delivery
Maternal quality of life	Maternal quality of Life based on questionnaire EQ-5D-5L.	Before 14 weeks of pregnancy, 32-34 weeks and 6 weeks postpartum
Postpartum weignt	Postpartum weight recorded 6 weeks postpartum	6 weeks postpartum

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal mortality	Maternal mortality- defined as death of the mother during pregnancy or within 42 days postpartum, due to any cause related to or aggravated by pregnancy or its management.	within 42 days postpartum
Caesarean section delivery		delivery
Premature rupture of the membranes		before week 34
Maternal number of days in hospitalization after delivery.		6 weeks postpartum
Maternal pregnancy related hypertension	Maternal pregnancy related hypertension- defines as Pregnancy-induced hypertension or preeclampsia as defined by the International Society for the Study of Hypertension in Pregnancy (ISSHP).	from 14 weeks of pregnancy to delivery
Maternal gestational diabetes mellitus	Maternal gestational diabetes mellitus as defined by diagnosis of diabetes after week 20 in a two-step approach according to the Carpenter/Coustan criteria.	from week 20 of pregnancy to delivery
maternal anaemina	Maternal anaemia defined by haemoglobin under 10 g/dL during pregnancy.	from 14 weeks of pregnancy to delivery
Food consumption change	Food consumption change based on 32-item semi-quantitative Food Frequency Questionnaire	before 14 weeks, 32-34 weeks of pregnancy and 6 weeks postpartum
Physical activity	Physical activity level based on the Kaiser Physical Activity Survey.	before 14 weeks, 32-34 weeks, 6 weeks postpartum
Change in lifestyle habits	Change in lifestyle habits based on Lifestyle behaviour questionnaire.	before 14 weeks, 32-34 weeks, 6 weeks postpartum
Neonatal number of days in hospitalization after delivery.		6 weeks after birth
Number of recruited participants	Recruitment Success (RE-AIM Principle: Reach and Adoption): assessment the ability to recruit participants over the course of the pilot. Recruitment efforts will focus on engaging a diverse demographic, particularly including women from low SES and high-risk backgrounds.	through study completion, an average of 1.5 years
Training and retention of study midwifes	Midwife Engagement (RE-AIM Principle: Adoption): Midwives at all centres will undergo a two-day training program tailored to the LIFETWIN intervention. Retention and engagement of midwives will be monitored throughout the study.	through study completion, an average of 1.5 years
Consistency of intervention delivery	Intervention Fidelity (RE-AIM Principle: Implementation): We will assess how consistently the intervention (8 lifestyle sessions) can be delivered, both face-to-face and remotely, ensuring quality and adherence across both centres.	through study completion, an average of 1.5 years
The number of participants retained throughout the pilot study	Participant Retention (RE-AIM Principle: Maintenance): Monitor retention rates of participants throughout the study period, with reasons for lack of adherence and dropout carefully recorded. This will help us understand both the feasibility of maintaining participant engagement and the practical challenges in long-term implementation	through study completion, an average of 1.5 years
Qualitative feedback on experiences with the intervention	Qualitative Feedback (RE-AIM Principle: Maintenance): Midwives and participants will be interviewed to assess how the intervention is perceived, experienced, and sustained over time. Insights from this feedback will be critical for informing the next phase of the study, especially regarding long-term adoption and sustainability.	through study completion, an average of 1.5 years

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: November 18, 2025
• First Submitted That Met QC Criteria: November 25, 2025
• First Posted (Estimated): December 8, 2025

Study Record Updates

• Last Update Posted (Actual): December 16, 2025
• Last Update Submitted That Met QC Criteria: December 15, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: twin pregnancy; lifestyle interventions; dichorionic
• Other Study ID Numbers: S68251

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No