Zusammenfassung (Niederländisch oder Französisch oder Englisch)
Trial Description
| Title | LIFETWIN: lifestyle intervention to improve twin pregnancy outcome: a multicentric randomized control trial - Pilot |
| Participants (P) | Women diagnosed with a dichorionic twin pregnancy, recruited before the 14th week of gestation |
| Intervention (I) | A complex lifestyle intervention delivered in eight structured 1h sessions (approximately every 2-3 weeks) conducted by a trained midwife, between weeks 16-36 of gestation. This is in additional to any standard advice. Each session covers: • Dietary counselling: Adopting a Mediterranean-based diet, adjusting for local food availability and cultural preferences. Includes individualized diet plan and a multivitamin supplementation program. • Physical activity: Encouraging at least 150 minutes of moderate aerobic exercise per week, with a focus on personalized goal setting. • Mindfulness and stress reduction: Introducing mindfulness-based stress reduction (MBSR) and mindfulness-based childbirth and parenting (MBCP) techniques. Includes guided exercises such as breath awareness, body scanning, and visualization. |
| Control (C) | Standard medical lifestyle advice for twin pregnancies for example: General nutrition advice encouraging a balanced diet rich in protein, iron, calcium, and folic acid. A daily prenatal vitamin tablet is recommended (a prescription is provided but not reimbursed) along with additional iron supplementation if needed. Moderate physical activity, like walking or swimming, is encouraged in the absence of complications, while high-impact activities, prolonged standing, and heavy lifting should be avoided. Adequate rest and general stress management (without specific programs) are also recommended to support maternal health and well-being throughout the pregnancy. Smoking cessation and abstinence from alcohol are also advised. |
| Outcome (O) | The primary outcome is a continuous measure of gestational age at delivery, recorded in days. For spontaneous pregnancies, gestational age is determined by ultrasound dating before 13 weeks and 6 days, while for IVF pregnancies, it is based on the embryo's age at the time of transfer. The design assumes a mean gestational age of 35.47 weeks with a standard deviation of 2.81 weeks. To detect a difference of 1 week in gestational age between the intervention and control groups with 80% power and a two-tailed significance level of 5%, the sample size calculation indicated a need for 124 participants in each group which has been increase to 137 to account for dropouts. |
| Trial Design | Parallel-group randomized controlled trial containing an integrated feasibility pilot study |
| Sample Size | For the pilot 81 participants, a total of 274 for the full study |
| Trial duration | Pilot 20 months |
| Budget | 668,000 € for the pilot in 4 sites |
Trial team
| Sponsor | UZ Leuven |
| Chief Investigator | Prof, Dr Roland Devlieger |
| External partners | N/A |
| Number of participating sites | Pilot study 4 sites, full study up to 15 sites |
DOCUMENTS
References
Funding scheme
