- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04806074
FOODLIT-Trial: Digital Behaviour Change Intervention to Improve Food Literacy Amidst the COVID-19 Pandemic
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Lisboa, Portugal
- Ispa - Instituto Universitário
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Single-moment, unspecified delivery of food literacy information
Non-specific food-related national and international guidelines were made digitally available in a website exclusively accessible to all the participants from the comparison group.
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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.
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Experimental: Personalised, weekly delivery of food literacy information matched with behaviour strategies
Food-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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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.
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Measure applied at baseline, one week post-intervention, and at 3-, 6- and 9-months follow-ups in order to evaluate.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessment of Health Action Process Approach Model (HAPA) Variables
Time Frame: Measure at baseline, one week post-intervention, and at 3-, 6- and 9-months follow-ups
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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. |
Measure at baseline, one week post-intervention, and at 3-, 6- and 9-months follow-ups
|
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Isabel Leal, Ph.D., Ispa - Instituto Universitário
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SFRH/BD/128528/2017
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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