NCT04806074

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
215

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 14, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 6, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 17, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 19, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 6, 2021

Completed
Last Updated

October 19, 2021

Status Verified

October 1, 2021

Enrollment Period

4 months

First QC Date

March 17, 2021

Last Update Submit

October 14, 2021

Conditions

Keywords

Food LiteracyBehaviour ChangeSustainabilityCOVID-19

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (1)

  • Assessment of Health Action Process Approach Model (HAPA) Variables

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

Study Arms (2)

Single-moment, unspecified delivery of food literacy information

PLACEBO COMPARATOR

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.

Behavioral: Comparison Group

Personalised, weekly delivery of food literacy information matched with behaviour strategies

EXPERIMENTAL

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.

Behavioral: Experimental Group

Interventions

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.

Personalised, weekly delivery of food literacy information matched with behaviour strategies

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.

Single-moment, unspecified delivery of food literacy information

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ISPA - Instituto Universitário

Lisbon, Portugal

Location

Related Publications (5)

  • 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.

    BACKGROUND
  • 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.

    PMID: 24308823BACKGROUND
  • 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.

    PMID: 32397776BACKGROUND
  • 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.

    PMID: 31892245BACKGROUND
  • 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.

    PMID: 23512568BACKGROUND

MeSH Terms

Conditions

Feeding BehaviorBehaviorCOVID-19

Condition Hierarchy (Ancestors)

Behavior, AnimalPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Isabel Leal, Ph.D.

    ISPA - Instituto Universitário

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 17, 2021

First Posted

March 19, 2021

Study Start

August 14, 2020

Primary Completion

December 6, 2020

Study Completion

September 6, 2021

Last Updated

October 19, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations