| NCT ID | NCT05895604 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Oslo Metropolitan University |
| Condition | Maternal Behavior |
| Study Type | INTERVENTIONAL |
| Enrollment | 700 participants |
| Start Date | 2023-06-01 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 700 participants in total. It began in 2023-06-01 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The Norwegian government is implementing the Nurse Family Partnership program (NFP) to combat child abuse and social inequality. This study will examine NFP with an individually randomized controlled parallel-group trial. The study will enroll 700 mothers over three years, with half receiving NFP services and the other half receiving standard care. The primary outcome is violence towards mothers and their children, assessed through questionnaires and observation tests. The study will also evaluate the program's effects on various health-related outcomes using administrative data. Cost-effectiveness analyses will be conducted to compare NFP to existing services and improve its delivery efficiency.
Eligibility Criteria
Inclusion Criteria: Female; No previous live births; Currently pregnant; Gestation period less than 28 weeks (i.e., less than or equal to 27 weeks, 6 days) at time of recruitment; Live within an area serviced by a NFP Implementing Agency; Not currently enrolled in the study; professionals are concerned about the pregnancy / impending parenthood Exclusion Criteria: Women who have had a previous live birth; Women who are not currently pregnant; Women who are past their 28th week of gestation (i.e., greater than or equal to 28 weeks, 0 days) at time of recruitment; Women who live outside of an area serviced by a NFP Implementing Agency; Women who are currently enrolled in the study; professionals are not concerned about the pregnancy / impending parenthood
Contact & Investigator
Anne Grete Tøge, phd
PRINCIPAL INVESTIGATOR
Oslo Metropolitan University
Frequently Asked Questions
Who can join the NCT05895604 clinical trial?
This trial is open to female participants only, aged 16 Years or older, studying Maternal Behavior. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05895604 currently recruiting?
Yes, NCT05895604 is actively recruiting participants. Contact the research team at Anne-Grete.Toge@oslomet.no for enrollment information.
Where is the NCT05895604 trial being conducted?
This trial is being conducted at Bergen, Norway, Kristiansand, Norway, Sandnes, Norway, Trondheim, Norway and 1 additional location.
Who is sponsoring the NCT05895604 clinical trial?
NCT05895604 is sponsored by Oslo Metropolitan University. The principal investigator is Anne Grete Tøge, phd at Oslo Metropolitan University. The trial plans to enroll 700 participants.