Assessment of snacking behaviour in relation to mental well-being with the SnackBox

ISRCTN ISRCTN45046481
DOI https://doi.org/10.1186/ISRCTN45046481
Secondary identifying numbers IA-21-WATS-TIP2-125
Submission date
27/06/2022
Registration date
28/07/2022
Last edited
28/07/2022
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
Given the rising prevalence of overweight and obesity, a considerable amount of research has been carried out on eating motives, especially what motivates people to eat in between regular meals (snacking behaviour). However, most research studying these motives is either performed in controlled laboratory settings or using some form of self-reported assessment. Both these methods are known for their lack of validity. Therefore, this study introduces the SnackBox as an automated and objective dietary assessment method for snacking behaviour. The main aim of this study is to validate the SnackBox as an automated dietary assessment method for snacking behaviour when compared to a dietary recall method and in relation to physiological and mood states assessed with two wearable sensors and ecological momentary assessments.

Who can participate?
Healthy volunteers with a stationary job (desk job) aged 18 to 49 years old

What does the study involve?
Participants are asked to install a SnackBox at home or work and asked to use it for five working days over a 2-week period. On each of these measurement days, the participants are asked to eat at least one snack and one drink from the SnackBox, to refrain from snacks not included in the SnackBox and to wear the Chill+ device and Garmin VivoSmart 4 for the entire day. Additionally, the participants receive several questionnaires throughout these days to assess their dietary behaviour and their mood states.

What are the possible benefits and risks of participating?
The burden for the participant, timewise, is one hour for the intake session, 30 minutes on each of the measurement days to complete all questionnaires and 30 minutes for the final session. The participants are asked to eat only the preselected snacks during the five measurement days and at least one snack and drink per measurement day. Risks or other discomforts are not expected. No benefit is expected for the participant either.

Where is the study run from?
Stichting IMEC Nederland (Netherlands)

When is the study starting and how long is it expected to run for?
November 2021 to August 2022

Who is funding the study?
Stichting IMEC Nederland (Netherlands)

Who is the main contact?
Alex van Kraaij, Alex.vankraaij@imec.nl

Contact information

Miss Femke de Gooijer
Scientific

OnePlanet Research Centre
Bronland 10a
Wageningen
6708 WE
Netherlands

ORCiD logoORCID ID 0000-0003-2790-757X
Phone +31 (0)612156023
Email femke.degooijer@wur.nl

Study information

Study designNon-randomized non-blinded interventional study without control groups
Primary study designInterventional
Secondary study designNon randomised study
Study setting(s)Home
Study typeOther
Study type Participant information sheet
Scientific titleValidation of the assessment of snacking behaviour with the SnackBox in relation to physiological and mood state aspects, assessed with wearable sensors and ecological momentary assessments
Study acronymAphrodite
Study objectivesThe primary objective of this study is to validate the SnackBox as an automated dietary assessment method for snacking behaviour when compared to a dietary recall method and in relation to physiological and mood state aspects, assessed with, respectively, two wearable sensors and ecological momentary assessments.
Ethics approval(s)This study does not require medical ethics approval, the Daily Board of the Medical Ethics Committee Máxima MC (hereafter the Committee), has reviewed this research proposal. As a result of this review, the Committee decided that the rules laid down in the Medical Research involving Human Subjects Act (also known by its Dutch abbreviation WMO), does not apply to this research (ref: N21.099)

Approved 17/12/2021, the internal ethical committee of IMEC, Inmec (Holst Centre, imec the Netherlands, High Tech Campus 31, 5656 AE Eindhoven, The Netherlands; +31 (0)625335967; inmec@imec.nl), ref: IA-21-WATS-TIP2-125
Health condition(s) or problem(s) studiedEating behaviour
InterventionParticipants are asked to install a SnackBox at home or work and asked to use it for 5 working days over a 2-week period. Each of these measurement days, the participants are asked to eat at least one snack and one drink from the SnackBox, to refrain from snacks not included in the SnackBox and to wear the Chill+ device and Garmin VivoSmart 4 the entire day. Additionally, the participants receive several questionnaires throughout these days to assess their dietary behaviour and their mood states.
Intervention typeDevice
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)SnackBox
Primary outcome measureThe accuracy of the SnackBox in assessing snacking behaviour (snack event yes/no, grams) is measured by:
1. A comparison to a 5-hour dietary recall method (snack event yes/no, true:false positives and true:false negatives) at 11:30 a.m., 4:30 p.m. and 9:30 p.m. on each measurement day
2. A comparison to the weight of the overall consumed snacks (grams) measured using a scale at the end of the five measurement days
3. A comparison to the ecological momentary assessments (EMAs) prompted on participants’ smartphones (snack event yes/no, true:false positives and true:false negatives) at random and snack-event triggered moments during a measurement day
Secondary outcome measures1. Physiological data such as heart rate (mean and relative changes), skin conductance response rate (mean and rel. changes) , skin temperature (mean and relative changes) and acceleration (mean and relative changes) measured using a Garmin activity tracker (Vivosmart 4) and a Chill+ activity tracker throughout each measurement day
2. Mood state (fatigued-energized, relaxed-stressed, sad-cheerful, bored-interested, hungry-satiated) measured using the visual analogue score (VAS) at random and snack-event triggered moments during a measurement day
Overall study start date01/11/2021
Completion date31/08/2022

Eligibility

Participant type(s)Healthy volunteer
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants40
Key inclusion criteria1. Between 18 years to 49 years old
2. The subject should have 5 days in which he/she works from a stationary location 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.
3. The subject 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 subject has no interfering dietary restrictions, such as being on a diet
5. The subject is not allergic to stainless steel or Ag/AgCl electrodes
6. The subject is not pregnant (unknown potential effect of Chill+ device on the child)
7. The subject has no acute and/or chronic cardiovascular and metabolic conditions (including e.g. diabetes mellitus)
8. The subject has no broken skin, cuts, or wounds at the sensor placement sites (wrist, upper arm)
9. The subject is not using medication with phototoxic side effects: tetracyclines, doxycycline, phenothiazines, dacarbazine, ketoprofen, lomefloxacin; to exclude the possibility of local skin irritation from prolonged irradiation by LED light
10. The subject is not wearing any other medical devices (e.g., Holter)
11. The subject does not have an implanted active device (e.g., device containing a battery)
12. The subject does not have any mental disorders
Key exclusion criteria1. The subject does not like the snacks and/or drinks provided in the study (there is an option to taste samples during the intake session)
2. Allergic to the snacks and/or drinks provided in the study (the list of ingredients will be available for all snacks and drinks at all times)
Date of first enrolment19/04/2022
Date of final enrolment01/08/2022

Locations

Countries of recruitment

  • Netherlands

Study participating centres

OnePlanet Research Centre - Wageningen
Plus Ultra II, Bronland 10
Wageningen
6708 WE
Netherlands
OnePlanet Research Centre - Nijmegen
Mercator II, Toernooiveld 300
Nijmegen
6525 EC
Netherlands

Sponsor information

Stichting IMEC Nederland (Holst Centre)
Industry

High Tech Campus 31
Eindhoven
PO Box 8550, 5605 KN
Netherlands

Phone +31 (0)40 402 0400
Email contact@holstcentre.com
Website https://holstcentre.com/

Funders

Funder type

Government

Province of Gelderland

No information available

Results and Publications

Intention to publish date01/12/2022
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryStored in non-publicly available repository, Not expected to be made available
Publication and dissemination planResults will be published in multiple high-impact peer-reviewed journals.
IPD sharing planInformed consent forms will be stored at the imec building Plus Ultra II in Wageningen, NL for 15 years. The forms will be kept in the locked cabinet which can only be accessed by the Principal Investigator/research coordinator. Participants’ contact information will be stored in the CastorEDC, which is a system that provides a full infrastructure for medical research studies, also complying with GDPR. CastorEDC allows specific access to specific people. Only the principal investigator in this study will have access to it and his access will be additionally secured by multi-factor authorization (2FA). The Principal Investigator must know which person belongs to which participant number during the trial to contact them in case of device malfunction/adverse event/participant’s withdrawal etc. Three months after the study has ended, data fields containing personal data (first name, last name, email, telephone) will be discarded. The exemplary data fields that will be stored in separate spreadsheets per person with a Subject ID which is a number between 1-99, generated randomly.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Participant information sheet 23/03/2022 28/06/2022 No Yes

Editorial Notes

27/06/2022: Trial's existence confirmed by the medical ethics committee Máxima MC.