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Food LiteracyNCT04806074

FOODLIT-Trial: Digital Behaviour Change Intervention to Improve Food Literacy Amidst the COVID-19 Pandemic

A study testing Experimental Group and Comparison Group in people with Food Literacy and Food Habits, run by ISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da Vida at 1 site in Portugal.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Given that healthy food-related habits are protective of both malnutrition and multiple noncommunicable diseases (including diabetes, heart disease, and cancer), and acknowledging that poor diets constitute a greater risk to mortality, it is essential to improve individuals' food-related knowledge, skills, and… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Experimental Group and Comparison Group
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
215 participants
Where
1 sitePortugal
Study dates
14 Aug 2020to 6 Sep 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Having a minimum of digital literacy to access, visualise and download online material related to the intervention;
  • Having the availability to participate in the intervention (11 weeks) and posterior follow-up moments.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Portugal1 site

  • ISPA - Instituto Universitário

    Lisbon

Other trials in Portugal

About this study

Official title: FOODLIT-Trial: Protocol of a Randomised Controlled Digital Intervention to Promote Food Literacy and Food Sustainability Behaviours in Adults Using the Health Action Process Approach (HAPA) and the Behaviour Change Techniques Taxonomy (BCTT) During the COVID-19 Pandemic

Given that healthy food-related habits are protective of both malnutrition and multiple noncommunicable diseases (including diabetes, heart disease, and cancer), and acknowledging that poor diets constitute a greater risk to mortality, it is essential to improve individuals' food-related knowledge, skills, and behaviours. Furthermore, the current public health context caused by the COVID-19 pandemic has reinforced the need for an adequate diet as a protective factor for one's global health.

In the ambit of the FOODLIT-PRO: Food Literacy Project (ref. SFRH/BD/128528/2017), a digital intervention to promote food literacy - that is, food-related knowledge, competencies, and behaviours - encompassing behavioural change strategies and psychological determinants (such as intention, planning, and self-efficacy) was developed.

With the online deliver of personalised evidence-based materials concerning food literacy, adult participants receive weekly challenges that promote their food-related knowledge (e.g., recognising food's origin and seasonality), competencies (e.g., as cooking and planning skills), and behaviours (e.g., tracking food intake, interpret nutritional labels). Matched with tailored behavioural change strategies (experimental group), both food literacy content and psychological aspects that relate to health behaviour are assessed weekly in order to evaluate the intervention's efficacy. Follow-ups at 3-, 6- and 9-months post intervention will be assessed.

Being tested
Experimental Group, Comparison Group
Keywords
Food Literacy, Behaviour Change, Sustainability, COVID-19
Medical subject headings
Feeding Behavior, Behavior, COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Experimental GroupBehavioural

    Evidence-based food-related national and international guidelines were (i) specifically arranged considering the Food Literacy Wheel (Rosas et al., 2021) and personalised materials contained these guidelines were designed, (ii) matched with tailored behaviour change techniques (BCT Taxonomy v1, by Michie et al., XXXX) that indicated how to develop/implement each competence/behaviour, and (iii) digitally delivered weekly. Psychological variables of the Health Action Process Approach model (HAPA; Schwarzer, 2008) were integrated in the intervention, to study potential food literacy's psychological determinants. Weekly introduction videos featuring the lead psychologist were made available. Participants' groups in WhatsApp were built to incentive experience-sharing. Food literacy domains and HAPA determinants were assessed weekly, post-intervention, and in follow-up moments 3-, 6- and 9-months after the intervention.

  • Comparison GroupBehavioural

    Food-related guidelines were delivered in a single moment in the first week of the intervention, on their original format and referring their original source (national's and international's entities websites). There was not a thematic for each specific week. No weekly introduction videos or WhatsApp groups existed in this condition. Food literacy domains and HAPA determinants were assessed weekly, post-intervention, and in follow-up moments 3-, 6- and 9-months after the intervention.

Study groups in NCT04806074
Study groupRoleWhat they receive
Single-moment, unspecified delivery of food literacy informationPlacebo comparatorNon-specific food-related national and international guidelines were made digitally available in a website exclusively accessible to all the participants from the comparison group.
Receives: Behavioral: Comparison Group
Personalised, weekly delivery of food literacy information matched with behaviour strategiesExperimentalFood-related tips - including theoretical knowledge, practical competencies, and behaviours - from national and international guidelines were specifically matched with Behaviour Change Techniques from the BCT Taxonomy v1. These personalised material were made digitally available in a website exclusively accessible to all the participants from the experimental group. Presenting each week's topic, a small video featuring the lead psychologist was also made available each week.
Receives: Behavioral: Experimental Group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Food Literacy (FOODLIT-Tool)

    Published at Appetite (Rosas Pimenta, Leal, \& Schwarzer, 2022), this is a 24-item tool that assesses the perception of food literacy-related knowledge, competencies, and behaviours, according to the Food Literacy Wheel (Rosas et al., 2021). The food literacy aspects are measured through five domains: (i) origin, (ii) production and quality, (iii) select and plan, (iv) environmentally safe, and (v) cooking skills.

    Measured: Measure applied at baseline, one week post-intervention, and at 3-, 6- and 9-months follow-ups in order to evaluate.

Secondary outcomes (1)

  1. Assessment of Health Action Process Approach Model (HAPA) Variables

    All measures of the HAPA model were based on the work of Schwarzer (2008) and Godinho, Alvarez, Lima, and Schwarzer (2014).

    A total of 46-items assessed (i) outcome expectations, (ii) risk perception, (iii) action self-efficacy, (iv) maintenance self-efficacy, (v) recovery self-efficacy, (vi) intention, (vii) action planning, (viii) coping planning, and (ix) action control.

    Measured: Measure at baseline, one week post-intervention, and at 3-, 6- and 9-months follow-ups

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Mar 2021
  2. Study start14 Aug 2020
  3. Primary completion6 Dec 2020
  4. Study completion6 Sep 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
215 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04806074
Sponsor's protocol ID
SFRH/BD/128528/2017
Status last verified
Oct 2021
First submitted
17 Mar 2021
Last updated
19 Oct 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Schwarzer, R. (2008) Modeling health behavior change: how to predict and modify the adoption and maintenance of health behaviors, Applied Psychology: An International Review, 57, 1-29.

  • Godinho CA, Alvarez MJ, Lima ML, Schwarzer R. Will is not enough: coping planning and action control as mediators in the prediction of fruit and vegetable intake. Br J Health Psychol. 2014 Nov;19(4):856-70. doi: 10.1111/bjhp.12084. Epub 2013 Dec 6.

    PubMed 24308823

  • Rosas R, Pimenta F, Leal I, Schwarzer R. FOODLIT-PRO: conceptual and empirical development of the food literacy wheel. Int J Food Sci Nutr. 2021 Feb;72(1):99-111. doi: 10.1080/09637486.2020.1762547. Epub 2020 May 13.

    PubMed 32397776

  • Rosas R, Pimenta F, Leal I, Schwarzer R. FOODLIT-PRO: Food Literacy Domains, Influential Factors and Determinants-A Qualitative Study. Nutrients. 2019 Dec 27;12(1):88. doi: 10.3390/nu12010088.

    PubMed 31892245

  • Michie S, Richardson M, Johnston M, Abraham C, Francis J, Hardeman W, Eccles MP, Cane J, Wood CE. The behavior change technique taxonomy (v1) of 93 hierarchically clustered techniques: building an international consensus for the reporting of behavior change interventions. Ann Behav Med. 2013 Aug;46(1):81-95. doi: 10.1007/s12160-013-9486-6.

    PubMed 23512568

Questions about this trial

What is this clinical trial studying?

A study testing Experimental Group and Comparison Group in people with Food Literacy and Food Habits, run by ISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da Vida at 1 site in Portugal.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Food Literacy (FOODLIT-Tool) (time frame: Measure applied at baseline, one week post-intervention, and at 3-, 6- and 9-months follow-ups in order to evaluate.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04806074, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2021.

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