"Are You Too Sweet?" project
| ISRCTN | ISRCTN10409779 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10409779 |
- Submission date
- 30/08/2023
- Registration date
- 25/10/2023
- Last edited
- 05/11/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
Danish children generally consume too many sweets and sugary drinks, which negatively impacts their health. Candy, cake, soda, ice cream, and fruit juice take the place of healthy food, increasing the risk of obesity and tooth decay. The purpose of the "Are You Too Sweet?" project is to assist Danish families in reducing their consumption of sweet treats and sugary beverages while maintaining good family times.
Who can participate?
All preschool children and their parents in the project schools can participate in the study.
What does the study involve?
Participant families will have the opportunity to test various games, tips, and other materials to gain insight into how they might change their sweet habits. The project is a collaboration with the healthcare services at the child's school and will be a part of the health consultation that all school children in Hvidovre Municipality are invited to. Children participating in the study will, in addition to height and weight measurements, also have their waist circumference measured. All participating families contribute to creating important knowledge that will be used to ensure children's health as best as possible. Families will receive a SWEET box, including interactive games, books, and more. After the project, they are welcome to keep everything.
What are the possible benefits and risks of participating?
The benefits of participating in the study are to try a range of materials and games to strengthen skills to structure discretionary choices and get insight into a child's dietary habits. No harmful effects are anticipated.
Where is the study run from?
DTU Food Institute (Denmark)
When is the study starting and how long is it expected to run for?
July 2019 to July 2021
Who is funding the study?
The Nordea Foundation (Denmark)
Who is the main contact?
Ms Sidse Marie Sidenius Bestle, simsib@food.dtu.dk
Contact information
Scientific
DTU Food Institute
Kemitorvet
Bygning 201
Kgs. Lyngby
2800
Denmark
 ORCID ID |
0000-0002-1465-6954 |
|---|---|
| Phone | +4560383707 |
| simsib@food.dtu.dk |
Principal Investigator
Senior researcher
Kemitorvet, Building 201
Kgs Lyngby
2800
Denmark
| ORCID ID |
0000-0002-6607-7575 |
|---|---|
| Phone | +4593518941 |
| apbj@food.dtu.dk |
Study information
| Study design | Cluster-randomized non-blinded controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | Home, Other therapist office |
| Study type | Prevention |
| Participant information sheet | 44208_PIS.pdf |
| Scientific title | A school health nurse delivered cluster randomized control intervention trial for reducing schoolchildren's intake of discretionary foods and drinks: the Are You Too Sweet? study. |
| Study acronym | AYTS |
| Study objectives | The hypothesis of the "Are You Too Sweet?" trial was that providing families with a multi-component intervention, consisting of dietary guidelines on discretionary choices, tools, and personalized consultation delivered by the school health nurses, would reduce child intake of discretionary choices, through increased family knowledge, awareness, and skills. |
| Ethics approval(s) | Ethics approval not required |
| Ethics approval additional information | The intervention is non-invasive and of educational character. To ensure that the trial did not require ethical approval, we received a confirmation from the regional research ethics committee. Approved 23/06/2020, Lone Gundelach, Regional scientific ethical committee (De Videnskabsetiske Komiteer for Region Hovedstaden), Kongens Vænge 2, 3400 Hillerød, Denmark; +45 38666395; vek@regionh.dk; ref: H-20036402. |
| Health condition(s) or problem(s) studied | Prevention of the negative impact of discretionary food on the health of preschool children |
| Intervention | The study is designed as a 3.5-month cluster-randomised non-blinded controlled trial. The cluster-randomisation of the schools will be conducted using R software, taking into account local socioeconomic status (municipalities ranking). Six schools from a Danish municipality will be randomised to either the intervention group (n = 4) or the control group (n = 2). Families with schoolchildren (5-7 years) starting in one of the participating schools are eligible for participation. Data collection will take place at baseline before the intervention starts and 3.5 months after the intervention starts. In addition to standard health guidance by the school health nurses, families are required to register their children's intake of discretionary choices, which will be shared with the school health nurse to provide individualised guidance on discretionary choices. The school health nurse will give the child and parent a box with home-use materials to motivate, inspire, and provide skills for reducing discretionary choices. The control group receives the standard health consultation, which is mandatory in Denmark. Parents in both intervention and control groups will be asked to answer a questionnaire and a 7-day dietary record (on behalf of their child) before the consultation and again 3.5 months after. |
| Intervention type | Behavioural |
| Primary outcome measure | Child intake of discretionary food and drinks measured using a seven-day dietary record in October - November 2020 (seven consecutive days, by continuous enrolments) at baseline and 3.5 months after the start of the intervention in February – March 2021 |
| Secondary outcome measures | 1. Energy from added sugar, other macronutrients and food groups measured using data from a food data bank and a seven-day dietary record in October - November 2020 and 3.5 months after the start of the intervention in February – March 2021 2. Parental practices, parental knowledge, and self-efficacy measured using a Parent completed questionnaire in October - November 2020 and 3.5 months after the start of the intervention in February – March 2021 |
| Overall study start date | 01/07/2019 |
| Completion date | 01/07/2021 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Child |
| Lower age limit | 5 Years |
| Upper age limit | 8 Years |
| Sex | Both |
| Target number of participants | 200 |
| Total final enrolment | 153 |
| Key inclusion criteria | All children aged between 5 and 8 years old attending one of the six project schools, if one parent has sufficient Danish to fill out a questionnaire |
| Key exclusion criteria | Not meeting the participant inclusion criteria |
| Date of first enrolment | 01/04/2020 |
| Date of final enrolment | 01/10/2020 |
Locations
Countries of recruitment
- Denmark
Study participating centre
Hvidovre
2650
Denmark
Sponsor information
University/education
Kemitorvet, building 201
Kongens Lyngby
2800
Denmark
| Phone | + 45 35 88 74 25 |
|---|---|
| apbj@food.dtu.dk | |
| Website | http://www.dtu.dk/english |
"ROR" |
https://ror.org/04qtj9h94 |
Funders
Funder type
Charity
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Nordea Foundation
- Location
- Denmark
Results and Publications
| Intention to publish date | 01/11/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Study protocol (published in 2020) Dietary outcomes (under review in Public health Nutrition) Qualitative evaluation (two papers published in 2022) Secondary quantitative outcomes: mediation mechanisms (under preparation) |
| IPD sharing plan | The datasets generated and analysed during the current study will be available on request. from Sidse Marie Sidenius Bestle, simsib@food.dtu.dk. Details of data anonymization will be provided at a later date. Consent was obtained from all participants, for use in the current research question. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other publications | parents’ perceptions and use of the ‘Are you too sweet?’ intervention components and tools | 29/06/2022 | 08/09/2023 | Yes | No |
| Other publications | qualitative sub-study | 15/09/2022 | 08/09/2023 | Yes | No |
| Participant information sheet | 08/09/2023 | No | Yes | ||
| Protocol article | 21/12/2020 | 08/09/2023 | Yes | No | |
| Results article | 26/03/2024 | 05/11/2024 | Yes | No |
Additional files
Editorial Notes
05/11/2024: Publication reference added.
24/10/2023: Study's existence confirmed by the funder Nordea Foundation (Nordea Fonden) (Denmark).
