Lifestyle Intervention to Improve Twin Pregnancy Outcomes
NCT ID: NCT07270640
Last Updated: 2025-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
81 participants
INTERVENTIONAL
2025-12-05
2027-06-30
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Intervention
Lifestyle coaching sessions
LIFETWIN
The LIFETWIN intervention provides 8 coaching sessions to women during pregnancy, focusing on nutrition (including multivitamin intake), physical activity and stress reduction.
Control
Standard of care
No interventions assigned to this group
Interventions
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LIFETWIN
The LIFETWIN intervention provides 8 coaching sessions to women during pregnancy, focusing on nutrition (including multivitamin intake), physical activity and stress reduction.
Eligibility Criteria
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Inclusion Criteria
* 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
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
18 Years
FEMALE
No
Sponsors
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Universitaire Ziekenhuizen KU Leuven
OTHER
Responsible Party
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Locations
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CHU Brugmann
Brussels, , Belgium
Ziekenhuis Oost-Limburg
Genk, , Belgium
UZ Leuven
Leuven, , Belgium
Hôpital de la Citadelle
Liège, , Belgium
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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S68251
Identifier Type: -
Identifier Source: org_study_id