Feedback on snacking behaviour, assessed with the SnackBox in relation to mood
| ISRCTN | ISRCTN54562674 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN54562674 |
| Secondary identifying numbers | IM-NL-SP-2023-0004-A001 |
- Submission date
- 13/07/2023
- Registration date
- 23/08/2023
- Last edited
- 05/10/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
To investigate snacking behaviour and how to affect it in relation to mood and physiology, the study team developed the SnackBox. The SnackBox accurately tracks snacking behaviour without actions of the researcher or user and then uses this information to trigger ecological momentary assessments to assess perceived mental well-being or just-in-time-adaptive interventions (JITAIs) to support healthy snacking behaviour. This study will investigate the effect of JITAIs on snacking behaviour. The primary objective of this study is to validate the effect of JITAIs (Just-In-Time-Adaptive Interventions) on snacking behaviour, assessed with the SnackBox. As secondary objectives, the study investigates the effect of the JITAIs on participants’ mood, and if and which factors (demographics, eating behaviour scores, mental well-being scores and physiology) affect JITAI outcomes.
Who can participate?
Adults aged between 18 and 49 years old who have at least eight days in which he/she works from a location with a stationary place to take breaks (f.e. desk or canteen) within a maximum period of 14 days.
What does the study involve?
Participation will consist of a pre-screening questionnaire, an intake session, 10 measurement days (divided over 14 days) and a hand-over session. Participants are asked to set up the Snackbox at their desk at home or at the office/break room for 10 days spread over 14 days at maximum. In the evenings you are asked to bring the SnackBox to your living room or other location you spend your evening. You will also wear the Garmin only on those 10 days.
What are the possible benefits and risks of participating?
In this study, no discomforts or side effects are expected. If you do experience such issues, immediately contact the principal investigator. It is important that you properly consider the possible advantages and disadvantages before you decide to participate. You will not personally receive any advantage from taking part in this study. Your participation may contribute to more knowledge about SnackBox. Disadvantages are possible discomforts of the measurements in the study, the main burden for the participant is expected to be the refrainment from other snacks on measurement days and the numerous questionnaires that need to be filled out.
Where is the study run from?
OnePlanet Research Center (Netherlands)
When is the study starting and how long is it expected to run for?
December 2022 to November 2023
Who is funding the study?
Province of Gelderland (Netherlands)
Who is the main contact?
Alex van Kraaij (Principal Investigator), Alex.vankraaij@imec.nl
Contact information
Principal Investigator
Bronland 10
Wageningen
6708 WE
Netherlands
 ORCID ID |
0000-0002-8592-8611 |
|---|---|
| Phone | +31627898403 |
| alex.vankraaij@imec.nl |
Public
Bronland 10
Wageningen
6708 WE
Netherlands
| Phone | +31627898403 |
|---|---|
| alex.vankraaij@imec.nl |
Scientific
Bronland 10
Wageningen
6708 WE
Netherlands
| Phone | +31627898403 |
|---|---|
| alex.vankraaij@imec.nl |
Study information
| Study design | Randomized controlled single-blind interventional study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Home, Workplace |
| Study type | Prevention, Quality of life |
| Participant information sheet | 43948 PIS v3 07Mar2023.pdf |
| Scientific title | Feedback on snacking behaviour, assessed with the SnackBox in relation to mood |
| Study acronym | Aphrodite II |
| Study objectives | The primary objective of this study is to validate the effect of a just-in-time-adaptive intervention (JITAI) on snacking behaviour in daily life, assessed with the SnackBox. |
| Ethics approval(s) | Ethics approval not required |
| Ethics approval additional information | The study has no medical grounds and does not fall under the medical scientific research act. We have sought an opinion on ethics approval both internally, with colleague Fabian Beutel from the internal medical ethical committee (INMEC) of Imec, and externally with the ‘Medische Ethische Toetsings Commissie” (METC) Veldhoven. |
| Health condition(s) or problem(s) studied | Overweight and obesity |
| Intervention | Participants are asked to install a SnackBox at the place where they usually snack (home and/or work) and to use it on their work days for a two-week period. On each of these measurement days, the participants are asked to take all in-between-meal food and drinks from the SnackBox, to refrain from snacks not included in the study and to wear the Garmin Vivosmart 5 the entire day. Additionally, the participants receive several questionnaires throughout each of these days to assess their meals, their mood states and some contextual information. The second week is the feedback week, where participants in the intervention group, in addition to the aforementioned questionnaires, receive the just-in-time-adaptive intervention (JITAI) on their smartphones. SnackBox: The SnackBox, a device developed within OnePlanet, will be used to record the snacking behaviour of the child during the measurement period. The device contains three weighing stations where different types of snacks can be weighted. Snacks will be weighted in special designed boxes. These compartments can be closed with an airtight lid. The SnackBox is placed on the participant’s home and must be connected to a power socket for power supply. Each of the three weighing stations exists of a load cell that measures the weight of its content. A Raspberry Pi (RBPi) computer, placed inside the station, collects and stores the weight data as well as data from the accelerometer located on the bottom of the weight station. The SnackBox also identifies when a snack compartment is not placed back on its weighing station and provides feedback to the user by using a blinking LED light and a buzzer sound. Lastly, the SnackBox registers which snack is placed on each of the weighing stations by registering its NFC tag. All snack compartments are labelled with NFC tags by the researchers prior to the measurements. Randomisation: For men and women separately, intervention is randomly assigned by drawing either ‘Intervention’ or ‘Control’ cards from a pool. |
| Intervention type | Behavioural |
| Primary outcome measure | Grams consumed from “healthy” and “unhealthy” snacks measured using the SnackBox at week 1 and week 2 |
| Secondary outcome measures | The effect of the JITAI messages on mood measured using the difference in mood Visual Analogue Scores (VAS) at random times of the day between the intervention week with JITAI messages and the baseline week without JITAI messages (corrected for that same difference in the control group) |
| Overall study start date | 01/12/2022 |
| Completion date | 30/11/2023 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 49 Years |
| Sex | Both |
| Target number of participants | 60 |
| Key inclusion criteria | 1. The participant must be between 18 years to 49 years old. 2. The participant should have at least eight days in which he/she works from a location with a stationary place to take breaks (f.e. desk or canteen) within a maximum period of 14 days. This can be either a complete working day from a desk at home or a complete working day from a desk at a work location, or a complete working day where breaks are taken at a canteen (at least three times a day). 3. The participant does not have Covid-19 and does not experience any remaining symptoms from previous exposure to Covid-19, such as loss of taste or smell. 4. The participant has no interfering dietary restrictions, such as being on a diet and has a restricted eating score lower than 3.13. 5. The participant is likely to snack, expressed in having an emotional eating score higher than 1.08. 6. The participant likes to snack on at least 1 or more of the high-caloric snack options on the list in section 7.1. 7. The participant is not allergic to stainless steel or Ag/AgCl electrodes. 8. The participant has no acute and/or chronic cardiovascular and metabolic conditions (including e.g. diabetes mellitus). 9. The participant has no broken skin, cuts, or wounds at the sensor placement sites (wrist, upper arm). 10. The participant is not using medication with phototoxic side effects: tetracyclines, doxycycline, phenothiazines, dacarbazine, ketoprofen, and lomefloxacin; to exclude the possibility of local skin irritation from prolonged irradiation by LED-light. 11. The participant is not wearing any other medical devices (e.g., Holter). 12. The participant does not have an implanted active device (e.g., a device containing a battery). 13. The participant does not have any mental disorders. |
| Key exclusion criteria | 1. Participant does not like the snacks and/or drinks provided in the study 2. Is allergic to the snacks and/or drinks provided in the study |
| Date of first enrolment | 01/05/2023 |
| Date of final enrolment | 01/11/2023 |
Locations
Countries of recruitment
- Netherlands
Study participating centres
Wageningen
6708 WH
Netherlands
Nijmegen
6525 EC
Netherlands
Sponsor information
Research organisation
Bronland 10
Wageningen
6708 WE
Netherlands
| Phone | +31612156023 |
|---|---|
| info@oneplanetresearch.nl | |
| Website | https://www.oneplanetresearch.nl/ |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 01/07/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer reviewed-journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Alex van Kraaij (Principal Investigator), Alex.vankraaij@imec.nl |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 3 | 07/03/2023 | 26/07/2023 | No | Yes |
Additional files
Editorial Notes
05/10/2023: The following changes have been made:
1. The recruitment end date has been changed from 01/10/2023 to 01/11/2023.
2. The overall study end date has been changed from 31/10/2023 to 30/11/2023 and the plain English summary updated accordingly.
26/07/2023: Trial's existence confirmed by Maxima MC.
