Improving dietary habits and feeding practices in the critical early phases of life using e-learning resources
| ISRCTN | ISRCTN10694967 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10694967 |
| Secondary identifying numbers | 320521 |
- Submission date
- 14/06/2022
- Registration date
- 19/06/2022
- Last edited
- 20/01/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
Poor diet quality is a leading cause of the global epidemic of non-communicable diseases (NCD), resulting in large disease-related negative impacts well beyond the health sector. The understanding of how life-long health is rooted in conditions early in life has developed enormously over the past 40 years, and it has become clear that early-life nutrition strongly influences health throughout life. Still, there is a critical lack of public health action and response to these insights.
Who can participate?
Pregnant women, parents of children aged 0 to 2 years, kindergarten personnel, health care centre personnel, municipality staff, and parents from marginalized groups.
What does the study involve?
In Nutrition Now, we will address NCD prevention through investments in dietary care in the first 1000 days of life. The project acts on the existing evidence-to-practice gap; that successful interventions are not being implemented at scale for the benefit of population health and community resilience. We have previously developed several e-learning interventions targeting nutrition, evaluated in controlled settings, showing promising results. They address diet during pregnancy, infancy, and toddlerhood, and include kindergarten educational tools. Now, we will scale up and implement the interventions in a community setting tailored to context and users’ needs, especially those from less advantaged groups. The effectiveness will be assessed in one municipality versus control before moving on to a fully scaled-up program at the county level.
What are the possible benefits and risks of participating?
We will advance the field by investigating the potential cumulative health effects of a life-course intervention approach and implementing multiple, low-cost, equitable, evidence-based e-learning resources at scale. The project harnesses an untapped potential for improving nutrition in early life through improved dietary guidance in primary health care and better feeding practices in kindergartens. There are no risks taking part in this study for the individual included in the intervention, for the underserved groups being interviewed, they might bring up issues themselves that may relate to feelings of not managing child feeding in a good way. Only professional interviewers will conduct these interviews.
Where is the study run from?
University of Agder (Norway)
When is the study starting and how long is it expected to run for?
December 2020 to December 2026
Who is funding the study?
The Norwegian Research Council (Norway)
Main contact
Professor Nina Cecilie Øverby (Norway)
nina.c.overby@uia.no
Contact information
Principal Investigator
University of Agder
PO Box 422
Kristiansand
4604
Norway
 ORCID ID |
0000-0002-1871-041X |
|---|---|
| Phone | +47 38 14 13 22 |
| nina.c.overby@uia.no |
Study information
| Study design | Current study design as of 28/09/2022: Single-centre non-randomized interventional hybrid type I study Previous study design: Single-centre non-randomized interventional hybrid type II study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Community |
| Study type | Prevention |
| Participant information sheet | Not available in web format yet |
| Scientific title | Scaling up evidence-based early-life nutrition interventions for community resilience and life-course health (Nutrition Now) |
| Study objectives | We hypothesise that successful adaptation and implementation of the e-learning resources at a large scale in a real-world setting will improve dietary habits and feeding practices in the critical early phases of life (first 1000 days), which are valid proxy endpoints for future health outcomes and cost-effectiveness over the life course |
| Ethics approval(s) | 1. Approved 09/12/2021, Regional Ethics Committee (Sør-Øst A, Gullhaugveien 1-3, 0484 Oslo, Norway; +47 22 84 55 11; rek-sorost@medisin.uio.no), ref: REC 322480. 2. Approved 24/01/2022, Faculty Ethical Committee (Universitetet i Agder, PO box 422, 4604 Kristiansand, Norway; +47 38141866; eli.andas@uia.no), ref: FEC 24/01/2022. 3. Approved 13/01/2022, Norwegian Data Protection Service (Norwegian Centre for Research Data, Harald Hårfagres gate 29, N-5007 Bergen, Norway; +47 55 58 21 17; nsd@nsd.no), ref: NSD 847590. |
| Health condition(s) or problem(s) studied | Promotion of healthy dietary habits in early life |
| Intervention | We have previously developed several interventions targeting pregnancy diet, parental feeding practices in relation to child diet, and early childhood education and care (ECEC) diet. These interventions have all shown to be promising in efficacy trials. In Nutrition Now these interventions will be combined and implemented at the community and county levels. The interventions are digital, largely video-based, and grounded in social cognitive theory, addressing the interaction between person, environment, and behaviour. In Nutrition Now, we will tailor our e-learning interventions to pregnant women and parents recruited through primary health care and tailor them to ECEC staff’s routines and schedules. Participants receiving the intervention will have access from pregnancy to a child age of 2 years. They will receive monthly and biweekly (dependent on child age) messages, and they can also access all parts of the digital e-learning resources at all times. The part targeting kindergartens is an intervention of 5 months that can be prolonged and adapted to the different kindergartens' settings. |
| Intervention type | Behavioural |
| Primary outcome measure | Current primary outcome measure as of 28/09/2022: Aspects of child diet quality, represented by intake of vegetables, fruits and berries, legumes/pulses and sugar sweetened beverages. Measured by questionnaires at baseline and at different ages depending on the age of the child when included in the study (at 6 weeks, 6 months, 12 months, 18 months, 24 months) _____ Previous primary outcome measure: Diet and diet-related behaviors in early life, measured by questionnaires at baseline and at different ages depending on the age of the child when included in the study (at 6 weeks, 6 months, 12 months, 18 months, 24 months) |
| Secondary outcome measures | 1. Parental and kindergarten staff feeding practices measured by questionnaires at baseline and 6 months (kindergarten), and at child ages 6 weeks, 6 months, 12 months, 18 months, 24 months 2. Maternal diet during pregnancy, measured by questionnaire at baseline 3. Maternal quality-of-life (pregnancy and later), measured with the Satisfaction with Life Scale at baseline 4. Breastfeeding rates, measured by questionnaire at baseline, ages 6 and 12 months 5. Anthropometric measures (parental and child), measured by self-reporting at baseline and at 6 weeks, 6 months, 12 months, and 18 months 6. Health-related quality of life (infant), measured with the Infant Quality of Life Scale at 6 weeks, 6 months, 12 months, and 18 months 7. Implementation costs, estimated through the study period 8. Child development, measured by Ages and Stages questionnaire at 18 months 9. Cost-effectiveness, evaluated using points 5, 6, 7, and 8 above at 18 months (added 28/09/2022) 10. Child eating enjoyment measured by Child Eating Enjoyment Scale (Data will be collected from ECEC staff at baseline and post-intervention (7 months after intervention start) and data will be collected from parents in at child age 12 months, 18 and 24 months) 11. Pregnancy complications measured by questionnaire (parental questionnaires at child age 6 weeks) 12. ECEC fruit and vegetable availability measured by receipts of fruit and vegetables bought (pre intervention and continuously until the end of data collection) 13. Municipal spend on activities related to early childhood nutrition and feeding practices (budget data from 2021-2024) |
| Overall study start date | 15/12/2020 |
| Completion date | 31/12/2026 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Mixed |
| Sex | Both |
| Target number of participants | 4000 |
| Key inclusion criteria | 1. Pregnant women 2. Parents of children aged 0 to 2 years old 3. Kindergarten staff 4. Municipality personnel 5. Persons from marginalized groups |
| Key exclusion criteria | Does not meet the inclusion criteria |
| Date of first enrolment | 01/10/2022 |
| Date of final enrolment | 01/07/2023 |
Locations
Countries of recruitment
- Norway
Study participating centre
Kristiansand
4604
Norway
Sponsor information
University/education
PO box 422
Kristiansand
4604
Norway
| Phone | +47 38 14 10 00 |
|---|---|
| post@uia.no | |
| Website | https://www.uia.no/ |
"ROR" |
https://ror.org/03x297z98 |
Funders
Funder type
Research council
Government organisation / National government
- Alternative name(s)
- Forskningsrådet, Norwegian Research Council, Research Council of Norway
- Location
- Norway
Results and Publications
| Intention to publish date | 30/11/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in publicly available repository |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | We plan to share anonymized data in the UiA deposit Dataverse, https://dataverse.no/dataverse/uia. This will be done no later than the acceptance for publication of the main findings from the final dataset (01/06/2025). We will retain our data for five years after data collection has stopped (meaning that data from our baseline will be available no later than 2027 or on 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? |
|---|---|---|---|---|---|
| Protocol article | 10/01/2023 | 30/01/2023 | Yes | No | |
| Protocol article | national scale-up of Nutrition Now | 09/01/2024 | 24/01/2024 | Yes | No |
| Other publications | Qualitative results | 05/06/2024 | 05/06/2024 | Yes | No |
| Other publications | Staff perspectives | 20/09/2024 | 24/09/2024 | Yes | No |
| Other publications | Staff's perceptions and needs | 30/10/2024 | 01/11/2024 | Yes | No |
| Other publications | Implementation strategies: lessons learned | 13/01/2025 | 20/01/2025 | Yes | No |
Editorial Notes
20/01/2025: Publication reference added.
01/11/2024: Publication reference added.
24/09/2024: Publication reference added.
05/06/2024: Publication reference added.
24/01/2024: Publication reference added.
30/01/2023: Publication reference added.
28/09/2022: The following changes were made to the trial record:
1. The study design was changed.
2. The primary outcome measure was changed.
3. The secondary outcome measures were updated.
17/06/2022: Trial's existence confirmed by the Norwegian Regional Committees for medical and health research ethics.
