跳至主要内容
临床试验/NCT06631950
NCT06631950招募中不适用

A Video Intervention on Young Adults' Fertility Awareness: a Large-scale Educational RCT in Denmark and Norway Measuring Fecundity Knowledge, Fertility Intentions, Reproductive Behavior and Long-run Impacts on Realized Fertility

University of Aarhus2 个研究点 分布在 2 个国家目标入组 10,000 人开始时间: 2024年11月26日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
10,000
试验地点
2
主要终点
Change in fecundity knowledge

研究概览

简要总结

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.

详细描述

This study is an experimental randomized controlled trial (RCT) based on data from the Danish National Birth Cohort (DNBC) and the Norwegian Mother and Child Cohort Study (MoBa). The RCT consists of young adult offspring from these two birth cohorts. The participants in the subsample will randomly be assigned to either an intervention or a control group. The RCT is part of the research project BIOSFER which is funded by an ERC Synergy Grant (European Union, 101071773). The research project aims to investigate the biologic and social causes of low fertility in modern societies.

The Danish National Birth Cohort (DNBC) is an ongoing nationwide cohort of women and their children with more than 20 years of follow-up data (Olsen et al., 2001). The cohort contains 92,000 women recruited 1996 to 2002, who experienced 100,000 pregnancies in total. It has a rich set of background variables including child's development and health up to 18 years, as well as self-reported measures from age 18 onwards. The oldest offspring in the DNBC will be 29 years old at the time of treatment.

The Norwegian Mother, Father and Child Cohort Study (MoBa) is built around 110,000 pregnancies recruited between 1999 and 2008 (Magnus et al., 2016). Children have reported on their own health and exposures from the age of 13, and health and socioeconomic status were reported by the parents before this age. The RCT study will be conducted on a subsample of the MoBa children who are at least 18 years old as of 2024. The oldest offspring in the MoBa will be 25 years old at the time of treatment.

Data collection for the RCT will take place between late 2024 and mid-2025. The RCT intervention group will receive a fecundity knowledge intervention. The intervention consists of a short (3 minutes) animated educational video containing information on risk factors of importance for fecundity.

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; future reproductive behavior- including attempts to conceive, termination of pregnancies and realized fertility The primary and secondary outcomes are measured with validated self-reported questionnaire items - except for certain items under reproductive behavior, such as 'realized fertility', which is measured through registries.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • Being underage
  • Not understanding Norwegian/Danish language

结局指标

主要结局

Change in fecundity knowledge

时间窗: 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

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

次要结局

  • 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.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验