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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04806074
Other study ID # SFRH/BD/128528/2017
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 14, 2020
Est. completion date September 6, 2021

Study information

Verified date October 2021
Source ISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da Vida
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


Recruitment information / eligibility

Status Completed
Enrollment 215
Est. completion date September 6, 2021
Est. primary completion date December 6, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Behavioral:
Experimental Group
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 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.

Locations

Country Name City State
Portugal ISPA - Instituto Universitário Lisboa

Sponsors (2)

Lead Sponsor Collaborator
ISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da Vida Fundação para a Ciência e a Tecnologia

Country where clinical trial is conducted

Portugal, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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). pii: E88. doi: 10.3390/nu12010088. — View Citation

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.

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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.
Measure at baseline, one week post-intervention, and at 3-, 6- and 9-months follow-ups
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