Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06631950
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-20
Brief Title:
Young Adults Fecundity Knowledge and Fertility Intentions and Reproductive Behavior
Sponsor:
None
Organization:
None
Study Overview
Official Title:
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 pregnancychildbirth fecundity-protective behaviors life goals realized fertility later in life
Detailed Description:
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 92000 women recruited 1996 to 2002 who experienced 100000 pregnancies in total It has a rich set of background variables including childs 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 110000 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 pregnancychildbirth 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
The target group is adult offspring of the two cohorts the DNBC and MoBa Outcomes of the trial will be analyzed for the total population participating in the RCT for specific age-groups for men and women by socioeconomic status of the individuals and their families or origin and for individuals with high and low risk preferences measured through questionnaires
Hypothesis young adult women and men have low-moderate fecundity knowledge and an educational digital intervention will have an impact on the interventions group fecundity knowledge and influence a their family building intentions to desire a first andor last child at a younger age b their fecundity-protective behaviors c their priority of life goals d their future reproductive behavior including attempts to conceive termination of pregnancies and realized fertility
The goal is to enhance young adults fecundity knowledge in order to secure that adults are able to make well-informed decisions regarding their family building and reproductive choices
Individuals who are included in the RCT sample will be randomized 11 by simple randomization to one of the following study arms
I Experimental arm fecundity knowledge intervention group In the experimental arm Individuals receive a short 3 minutes animated educational video on risk factors of importance for fecundity
II Control arm no fecundity knowledge provided
The investigators will use computer-based randomization methods When analyzing the data the data set will by necessity contain information on whether each individual is in the intervention or control group Coding and classification of outcome variables will be done jointly for the intervention and control group so this knowledge will not influence the investigators handling of the data
The 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 that will be sent out digitally The control group is not receiving such information As part of the overall BIOSFER project all offspring in both birth cohorts have received a Global Questionnaire at baseline including items and scales measuring fecundity knowledge and the participants family formationintentions regarding family formation and views on life goals Only participants having responded to the Global Questionnaire will be invited to the RCT study After the intervention both the intervention and the control group will receive identical questionnaire items and scales on fecundity knowledge and intentions regarding family formation and their views on life goals Hence all the respondents receive the questions that inform our outcome variables both before and after the intervention The participants in the intervention and control group will also be asked about their fecundity-protective behavior
Statistical analysis and interpretation of data
Overall 13106 23 of MoBa participants have responded to the Global Questionnaire In DNBC data collection of the Global Questionnaire will continue until April 2025 Currently 11900 27 of those who has been invited so far have responded to the Global Questionnaire Participants responding to the Global Questionnaire in DNBC and MoBa will receive an invitation to the RCT study
For the sample size calculation for the primary outcome the investigators expect a participation of 30 This is based on previous response rates within similar data collections in the two cohorts Power calculations for the primary outcome were performed with a 5 significance level The investigators follow convention and use 80 power as a cutoff for sufficient power Assuming a response rate of 30 there will be power to detect effects down to 5 percent 25pp in the full sample and 10 percent 5 pp among women and men when analyzed separately
The investigators also performed power calculations assessing how power varies as a function of sample size and effect size The MoBa cohort is used as example where the RCT invitation will be sent to all 13 106 respondents of the MoBa Global Questionnaire The investigators also assess the power for sex-specific analysis with 8325 women and 4723 men 58 answering other are excluded from these The power calculation assumes an even split between groups and then tests the power for difference in means
In the power calculations the investigators use a fertility knowledge percentage correct score see eg Bunting et al 2013 with a range from 0 to 100 The investigators assume a baseline of knowledge of 50 percentage points somewhat less than what was found in Bunting et al 2013 65-68 points The investigators expect the knowledge level to be lower in our population compared to the population in Bunting et al 2013 The population in this study is younger 18-29 compared to Bunting et als 318 years old Further 26 of Bunting et als population already had children which is expected to be lower in our population Hence younger age and not being a parent will most likely effect the knowledge level With a standard deviation of 25 taken from Bunting et al 2013 p 389 the investigators then assess the power to detect effects of 25 5 75 and 10 percentage points
Across all samples and down to a 10 response rate the investigators can detect effects of 75 percentage points or higher In the combined sample the investigators can detect effects as small as 5 percentage points at a 10 response rate To detect the smallest effects 25 percentage points a 30 response rate is required for the combined sample
For women the investigators can detect effects as small as 5 percentage points with a 10 response rate To detect effects of 25 percentage points require a 40 response rate In the male sample effects of 75 percentage points and larger can be detected with a 10 response rate Detecting a 5 pp effect requires 20 response and 25 pp requires more than 50 response
The effectiveness of the RCT will be analyzed using an intention-to-treat ITT approach
The results of the quantitative evaluation primary and secondary outcomes is planned to be analyzed and published in more than one scientific paper
The quantitative evaluation of RCT is complemented by a qualitative evaluation looking into the participants thoughts on the fecundity knowledge intervention highlighting what works for whom under which circumstances but also their overall thought on family formation
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 92000 women recruited 1996 to 2002 who experienced 100000 pregnancies in total It has a rich set of background variables including childs 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 110000 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 pregnancychildbirth 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
The target group is adult offspring of the two cohorts the DNBC and MoBa Outcomes of the trial will be analyzed for the total population participating in the RCT for specific age-groups for men and women by socioeconomic status of the individuals and their families or origin and for individuals with high and low risk preferences measured through questionnaires
Hypothesis young adult women and men have low-moderate fecundity knowledge and an educational digital intervention will have an impact on the interventions group fecundity knowledge and influence a their family building intentions to desire a first andor last child at a younger age b their fecundity-protective behaviors c their priority of life goals d their future reproductive behavior including attempts to conceive termination of pregnancies and realized fertility
The goal is to enhance young adults fecundity knowledge in order to secure that adults are able to make well-informed decisions regarding their family building and reproductive choices
Individuals who are included in the RCT sample will be randomized 11 by simple randomization to one of the following study arms
I Experimental arm fecundity knowledge intervention group In the experimental arm Individuals receive a short 3 minutes animated educational video on risk factors of importance for fecundity
II Control arm no fecundity knowledge provided
The investigators will use computer-based randomization methods When analyzing the data the data set will by necessity contain information on whether each individual is in the intervention or control group Coding and classification of outcome variables will be done jointly for the intervention and control group so this knowledge will not influence the investigators handling of the data
The 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 that will be sent out digitally The control group is not receiving such information As part of the overall BIOSFER project all offspring in both birth cohorts have received a Global Questionnaire at baseline including items and scales measuring fecundity knowledge and the participants family formationintentions regarding family formation and views on life goals Only participants having responded to the Global Questionnaire will be invited to the RCT study After the intervention both the intervention and the control group will receive identical questionnaire items and scales on fecundity knowledge and intentions regarding family formation and their views on life goals Hence all the respondents receive the questions that inform our outcome variables both before and after the intervention The participants in the intervention and control group will also be asked about their fecundity-protective behavior
Statistical analysis and interpretation of data
Overall 13106 23 of MoBa participants have responded to the Global Questionnaire In DNBC data collection of the Global Questionnaire will continue until April 2025 Currently 11900 27 of those who has been invited so far have responded to the Global Questionnaire Participants responding to the Global Questionnaire in DNBC and MoBa will receive an invitation to the RCT study
For the sample size calculation for the primary outcome the investigators expect a participation of 30 This is based on previous response rates within similar data collections in the two cohorts Power calculations for the primary outcome were performed with a 5 significance level The investigators follow convention and use 80 power as a cutoff for sufficient power Assuming a response rate of 30 there will be power to detect effects down to 5 percent 25pp in the full sample and 10 percent 5 pp among women and men when analyzed separately
The investigators also performed power calculations assessing how power varies as a function of sample size and effect size The MoBa cohort is used as example where the RCT invitation will be sent to all 13 106 respondents of the MoBa Global Questionnaire The investigators also assess the power for sex-specific analysis with 8325 women and 4723 men 58 answering other are excluded from these The power calculation assumes an even split between groups and then tests the power for difference in means
In the power calculations the investigators use a fertility knowledge percentage correct score see eg Bunting et al 2013 with a range from 0 to 100 The investigators assume a baseline of knowledge of 50 percentage points somewhat less than what was found in Bunting et al 2013 65-68 points The investigators expect the knowledge level to be lower in our population compared to the population in Bunting et al 2013 The population in this study is younger 18-29 compared to Bunting et als 318 years old Further 26 of Bunting et als population already had children which is expected to be lower in our population Hence younger age and not being a parent will most likely effect the knowledge level With a standard deviation of 25 taken from Bunting et al 2013 p 389 the investigators then assess the power to detect effects of 25 5 75 and 10 percentage points
Across all samples and down to a 10 response rate the investigators can detect effects of 75 percentage points or higher In the combined sample the investigators can detect effects as small as 5 percentage points at a 10 response rate To detect the smallest effects 25 percentage points a 30 response rate is required for the combined sample
For women the investigators can detect effects as small as 5 percentage points with a 10 response rate To detect effects of 25 percentage points require a 40 response rate In the male sample effects of 75 percentage points and larger can be detected with a 10 response rate Detecting a 5 pp effect requires 20 response and 25 pp requires more than 50 response
The effectiveness of the RCT will be analyzed using an intention-to-treat ITT approach
The results of the quantitative evaluation primary and secondary outcomes is planned to be analyzed and published in more than one scientific paper
The quantitative evaluation of RCT is complemented by a qualitative evaluation looking into the participants thoughts on the fecundity knowledge intervention highlighting what works for whom under which circumstances but also their overall thought on family formation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None