NCT06631950

Brief Summary

This RCT investigates the impact of an educational video on fecundity knowledge among young adults. The video discusses several risk factors associated with fecundity, such as age and smoking. The primary outcome measure of the RCT is fecundity knowledge. The knowledge level is defined based on the following factors: Age; smoking; sexually transmitted infections; Success of spontaneous pregnancy according to female age; Success of pregnancy according to female age and fertility treatment. The secondary outcomes are: intentions regarding the timing of desired pregnancy/childbirth; fecundity-protective behaviors; life goals; realized fertility later in life.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,000

participants targeted

Target at P75+ for not_applicable

Timeline
235mo left

Started Nov 2024

Longer than P75 for not_applicable

Geographic Reach
2 countries

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress7%
Nov 2024Oct 2045

First Submitted

Initial submission to the registry

September 20, 2024

Completed
18 days until next milestone

First Posted

Study publicly available on registry

October 8, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

November 26, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
19.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2045

Expected
Last Updated

April 2, 2025

Status Verified

March 1, 2025

Enrollment Period

1 year

First QC Date

September 20, 2024

Last Update Submit

March 28, 2025

Conditions

Keywords

Fecundity knowledgeFertility awarenessFamily intentionsVideo intervention

Outcome Measures

Primary Outcomes (1)

  • Change in fecundity knowledge

    Fecundity knowledge level in intervention arm versus control arm. Fecundity knowledge is measured with validated self-reported questionnaire items; revised Cardiff Fertility Knowledge Scale. The values range from 1-100, higher scores indicate higher knowledge level. The knowledge level is defined as change in knowledge level of the following factors: * Age, smoking, STI (Chlamydia) * Success of spontaneous pregnancy according to female age * Success of pregnancy according to female age and fertility treatment

    Measured immediately after intervention (educational video), and at a later point of time (likely within 1-2 years) depending on the data collection logistics for the two cohorts

Secondary Outcomes (7)

  • Change in intentions regarding timing of pregnancy/childbirth

    Measured immediately after intervention (educational video), and at a later point of time (likely within 1-2 years) depending on the data collection logistics for the two cohorts

  • Change in life goals

    Measured immediately after intervention (educational video), and at a later point of time (likely within 1-2 years) depending on the data collection logistics for the two cohorts

  • Change in adopting fecundity-protective behaviors

    Measured immediately after intervention (educational video), and at a later point of time (likely within 1-2 years) depending on the data collection logistics for the two cohorts

  • Change in realized fertility (followed up in registers)

    3, 5, 10 years and 20 years follow-up in national birth registers' after the intervention.

  • Change in realized fertility (followed up in registers)

    3, 5, 10 years and 20 years follow-up in national birth registers' after the intervention.

  • +2 more secondary outcomes

Study Arms (2)

Fecundity knowledge intervention

EXPERIMENTAL

In the experimental arm, participants receive a short (3 minutes) educational video on risk factors of importance for fecundity.

Other: Educational intervention

Control

NO INTERVENTION

In the no-intervention arm, the participants do not receive the intervention (a short educational video).

Interventions

The educational intervention group will be provided with information that should allow them to correctly answer questions on fecundity knowledge and fecundity risks factors. The fecundity information will be provided through a short animated educational video (3 minutes) that will be sent out digitally. The control group is not receiving such information.

Fecundity knowledge intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Offspring of mothers part of the DNBC and MoBa cohorts
  • Being of legal age
  • Responded to the Global Questionnaire at baseline

You may not qualify if:

  • Being underage
  • Not understanding Norwegian/Danish language

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Aarhus University/DNBC/SSI

Aarhus, Denmark

RECRUITING

Norwegian Institute of Public Health/MoBa

Oslo, Norway

COMPLETED

MeSH Terms

Interventions

Early Intervention, Educational

Intervention Hierarchy (Ancestors)

Child Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health Services

Study Officials

  • Mikko Myrskylä, Professor

    Max Planck Institute for Demographic Research, Rostock, Germany

    PRINCIPAL INVESTIGATOR
  • Cecilia Ramlau-Hansen, Professor

    Department of Public Health - Department of Epidemiology, Aarhus University, Denmark

    PRINCIPAL INVESTIGATOR
  • Siri Eldevik Håberg, Professor

    Centre for Fertility and Health, Norwegian Institute of Public Health, Norway

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gritt Marie Hviid Malling, PhD student

CONTACT

Rannveig Kaldager Hart, Associate professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2024

First Posted

October 8, 2024

Study Start

November 26, 2024

Primary Completion

December 1, 2025

Study Completion (Estimated)

October 1, 2045

Last Updated

April 2, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will share

For data access, parties must contact DNBC and/or MoBa directly. The new research project must be approved by Danish or/and the Norwegian authorities and follow the procedures for data access in the DNBC/MoBa. All costs for assessing data will be covered by the party requesting the data.

Locations