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

Study Type

Interventional

Enrollment (Actual)

215

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Lisboa, Portugal
        • Ispa - Instituto Universitário

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
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.
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.
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.

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

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

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

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Isabel Leal, Ph.D., Ispa - Instituto Universitário

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 14, 2020

Primary Completion (Actual)

December 6, 2020

Study Completion (Actual)

September 6, 2021

Study Registration Dates

First Submitted

March 17, 2021

First Submitted That Met QC Criteria

March 17, 2021

First Posted (Actual)

March 19, 2021

Study Record Updates

Last Update Posted (Actual)

October 19, 2021

Last Update Submitted That Met QC Criteria

October 14, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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