Effectiveness of a diet information website targeting young adults before parenthood
| ISRCTN | ISRCTN44294662 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN44294662 |
- Submission date
- 31/01/2021
- Registration date
- 04/02/2021
- Last edited
- 23/05/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
Background and study aims
Non-communicable diseases (NCDs) such as obesity, type 2 diabetes, cardiovascular disease, cancer, and mental disorders, account for 85-90% of the disease burden in Norway. NCDs are complex diseases that are difficult and costly to treat, so identifying better strategies for primary prevention is crucial. Poor diet is a leading cause of NCDs, with a pronounced difference in diet quality across socioeconomic groups. Diet is especially important in early developmental phases, such as the first thousand days of life, but recent research indicates that diet before conception might be foundational for child development and health. There is limited information on how preconception diet is linked to health in the next generation, whether and to which degree maternal vs paternal dietary influences differ in this respect, and when preconception diet should be targeted to effectively promote long-term health. Recent publications highlight the window of opportunity that preconception phases represent for health in the next generation and specifically the importance of preconception diet. Digital interventions have the advantage of being cheap and having exceptional reach into populations hard to engage in research, and therefore a unique potential to address and reduce social inequalities in health. The aim of this study is to develop, implement and evaluate a digital intervention targeting diet aiming to promote a healthy preconception diet that may benefit subsequent pregnancies with the potential to promote newborn health and development.
Who can participate?
Men and women, aged 20-35, with no prior biological children
What does the study involve?
The participants will be randomly allocated to either the control or intervention group. The control group will not be given access to the intervention website, nor any other information, other than being asked to respond to follow-up questionnaires. The intervention group will be given access to a website providing messages on the importance of diet and how to improve diet each week for 6 months. The researchers will track participants until the birth of their first child and assess measures of maternal health. They will also assess newborn size at birth as an indicator of health.
What are the possible benefits and risks of participating?
The possible benefits include improved diet, improved quality of life and good health of prospective children. Due to the non-intrusive educational design of the intervention the researchers do not expect adverse events directly attributable to the intervention. Unintended effects could relate to participants’ concern about diet, e.g., disordered eating or eating disorders. The researchers will, however, take care to communicate diet-health messages in a sober manner.
Where is the study run from?
University of Agder (Norway)
When is the study starting and how long is it expected to run for?
The pilot started August 2021 and the main study is to start October 2021 and will last to April 2041
Who is funding the study?
University of Agder (Norway)
Who is the main contact?
Prof. Nina C. Øverby
nina.c.overby@uia.no
Contact information
Scientific
University of Agder, att Nina Øverby
PO 422
Kristiansand
4604
Norway
 ORCID ID |
0000-0002-1871-041X |
|---|---|
| Phone | +47 (0)38141324 |
| nina.c.overby@uia.no |
Public
University of Agder, att Elisabet Hillesund
PO 422
Kristiansand
4604
Norway
| ORCID ID |
0000-0003-0757-1861 |
|---|---|
| Phone | +47 (0)38141324 |
| nina.c.overby@uia.no |
Study information
| Study design | Randomized controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Internet/virtual |
| Study type | Prevention |
| Participant information sheet | ISRCTN44294662_PIS.pdf |
| Scientific title | Effectiveness of a web-based dietary intervention program targeting young adults prior to parenthood: a randomized controlled trial (PREPARED) |
| Study acronym | PREPARED |
| Study objectives | H1: 6 months of access to a digital dietary learning tool will improve male and female knowledge and skills in relation to diet and lead to healthier dietary behavior compared to a control group with no such access. H2: 6 months of access to a digital dietary learning tool will lead to larger improvements in diet and quality of life post-intervention compared to a control group with no such access. H3: Subsequent children of men and women with preconception access to the digital dietary learning tool, will have a lower prevalence of low (< 2500 g) and high (>4500 g) birthweight and of being small- or large for gestational age (SGA or LGA, respectively) than children of parents without such access. H4: Pregnant women with preconception access to a digital dietary learning tool will have a lower risk of excessive gestational weight gain, gestational diabetes, preeclampsia and preterm delivery compared to pregnant women without such access. |
| Ethics approval(s) | 1. Approved 11/08/2020, Regional Committees for Medical and Health Research Ethics (Regional Etisk komite Sør øst B, Gullhaugveien 1-3, 0484 Oslo, Norway; +47 (0)22845511; rek-sorost@medisin.uio.no), ref: 78104 2. Approved 18/09/2020, Norwegian centre for research data (Norsk senter for forskningsdata AS, Harald Hårfagres gate 29, N-5007 Bergen, Norway; +47 (0)55 58 21 17 (# 1); Oyvind.straume@nsd.no), ref: NSD: 907212 3. Approved 17/11/2020, Faculty of Health and Sport Sciences ethics committee (University of Agder, PO 422, N-4604 Kristiansand, Norway; +47 (0)38141000; anne.skisland@uia.no), ref: FEC 20/10119 |
| Health condition(s) or problem(s) studied | Prevention of pregnancy risk outcomes and neonatal risk outcomes in the general population aged 20-35 years |
| Intervention | Current interventions as of 21/09/2021: In this project the researchers will develop, implement and evaluate a digital intervention targeting diet aiming to promote a healthy preconception diet that may benefit fetal conditions in subsequent pregnancies with the potential to promote fetal and neonatal health and development. The intervention will target both men and women individually, with a special focus on reaching men due to the less communicated relevance of male preconception diet for the health of prospective children. Participants will be randomised, according to a predefined list, after they have filled in baseline data (questionnaires and food registrations), into either the intervention or the control group. The control group will not be given access to the intervention website, nor any other information, except information on the importance of control groups for research, and that they will be asked to respond to follow up questionnaires. The intervention group will be given access to a website with information about the importance of diet in different stages of life. Every week new messages will be given of the importance of diet and how to improve diet for 6 months. ______ Previous interventions: In this project the researchers will develop, implement and evaluate a digital intervention targeting diet aiming to promote a healthy preconception diet that may benefit fetal conditions in subsequent pregnancies with the potential to promote fetal and neonatal health and development. The intervention will target both men and women, with a special focus on reaching men due to the less communicated relevance of male preconception diet for the health of prospective children. Participants will be randomised, according to a predefined list, after they have filled in baseline data (questionnaires and food registrations), into either the intervention or the control group. The control group will not be given access to the intervention website, nor any other information, other than being asked to respond to follow up questionnaires. The intervention group will be given access to a website with information about the importance of diet in different stages of life. Every week new messages will be given of the importance of diet and how to improve diet for 6 months. |
| Intervention type | Behavioural |
| Primary outcome measure | Preconception diet (overall diet and diet quality) measured by food and nutrient intake and diet scores at baseline, and at 6 and 12 months follow up and in a short questionnaire every year until the first child is born |
| Secondary outcome measures | Current secondary outcome measures as of 21/09/2021: All data retrieved from the Medical Birth Registry, Norway: 1. Preconception quality of life measured by RAND 12 and Satisfaction with life scale at baseline and every follow-up 2. Pregnancy health data retrieved from the Medical Birth Registry, Norway after the future first child is born: 2.1. Gestational weight gain (GWG) 2.2. Preeclampsia 2.3. Gestational diabetes (GDM) 2.4. Preterm delivery 2.5. Hypertensive disorders in pregnancy 3. Neonatal health data retrieved from the Medical Birth Registry, Norway after the future first child is born: 3.1. Birth weight, length and head circumference 3.2. LGA/SGA 3.3. Birthweight ≥4000 g 3.4. Ponderal index (kg/cm³) _____ Previous secondary outcome measures: All data retrieved from the Medical Birth Registry, Norway: 1. Preconception quality of life measured by SF-12 at baseline and then at every follow-up 2. Pregnancy health data retrieved from the Medical Birth Registry, Norway after the future first child is born: 2.1. Gestational weight gain (GWG) 2.2. Preeclampsia 2.3. Gestational diabetes (GDM) 2.4. Preterm delivery 2.5. Hypertensive disorders in pregnancy 3. Neonatal health data retrieved from the Medical Birth Registry, Norway after the future first child is born: 3.1. Birth weight, length and head circumference 3.2. LGA/SGA 3.3. Birthweight ≥4000 g 3.4. Ponderal index (kg/cm³) |
| Overall study start date | 11/08/2020 |
| Completion date | 30/04/2041 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 7,000 |
| Key inclusion criteria | 1. Born in the years 1986-2001 2. Have no biological children 3. Possess an 11-digit identification number 4. Literate in Norwegian 5. Have access to a smartphone or another digital device |
| Key exclusion criteria | 1. Biological parent already 2. Not literate in Norwegian or another Scandinavian language 3. Not in possession of a Norwegian personal identification number |
| Date of first enrolment | 15/10/2021 |
| Date of final enrolment | 30/11/2022 |
Locations
Countries of recruitment
- Norway
Study participating centre
Kristiansand
4604
Norway
Sponsor information
University/education
PO 422
Kristiansand
4604
Norway
| Phone | +47 (0)38141324 |
|---|---|
| nina.c.overby@uia.no | |
| Website | http://www.uia.no/en |
"ROR" |
https://ror.org/03x297z98 |
Funders
Funder type
University/education
Private sector organisation / Universities (academic only)
- Alternative name(s)
- University of Agder, UiA
- Location
- Norway
Results and Publications
| Intention to publish date | 01/06/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Stored in repository |
| Publication and dissemination plan | 1. Protocol to be submitted for publication by early March 2021 2. Planned publications in high-impact peer-reviewed journals 3. When the project is ended and the main publication reported, the data will be shared according to project guidelines and request |
| IPD sharing plan | We plan to share anonymized data in the UiA deposit Dataverse, this will be done no later than acceptance for publication of the main findings from the final dataset. We will retain our data for 5 years after data collection has stopped (meaning that data from our baseline will be available at least in 2027 or upon publication of main findings). Standard meta-information about the data will be uploaded. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 01/03/2021 | No | Yes | ||
| Protocol article | 01/12/2021 | 03/12/2021 | Yes | No |
Additional files
- ISRCTN44294662_PIS.pdf
- Uploaded 01/03/2021
Editorial Notes
23/05/2022: The recruitment end date was changed from 01/05/2022 to 30/11/2022.
03/12/2021: Publication reference added.
18/10/2021: The recruitment start date was changed from 25/10/2021 to 15/10/2021.
21/09/2021: The following changes were made to the trial record:
1. The interventions were changed.
2. The secondary outcome measures were changed.
3. The recruitment start date was changed from 02/08/2021 to 25/10/2021.
4. The participant level data was changed from "To be made available at a later date" to "Stored in repository"
5. The publication and dissemination plan was updated.
18/05/2021: The recruitment start date was changed from 01/05/2021 to 02/08/2021.
01/03/2021: The participant information sheet has been uploaded as an additional file.
03/02/2021: Trial's existence confirmed by the Regional Committees for Medical and Health Research Ethics.
