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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05403060
Other study ID # 21-88
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2022
Est. completion date May 23, 2022

Study information

Verified date February 2023
Source Centro Universitario de Ciencias de la Salud, Mexico
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Randomized controlled trial by conglomerates whose objective is to evaluate the effectiveness of an educational nutritional intervention, based on the Social Cognitive Theory, for the increase in the consumption of vegetables and fruits and the decrease in the consumption of ultra-processed foods in adolescent high school students, in the University of Guadalajara, in Guadalajara, Jalisco.


Description:

Background: Adolescent nutrition is of vital importance for their growth and development, at this stage eating habits for adult life are consolidated. However, currently the eating habits of adolescents are mainly characterized by a high consumption of ultra-processed foods and a low consumption of vegetables and fruits. Effective nutritional interventions focused on this age group can contribute to the prevention of adolescent diseases at the current stage and in later stages. Objective: To evaluate the efficacy of an educational nutritional intervention, based on the Social Cognitive Theory, to increase the consumption of vegetables and fruits and decrease the consumption of ultra-processed foods, in adolescent high school students at the University of Guadalajara (UDG), in Guadalajara, Jalisco, in the year 2022. Material and methods: Randomized controlled trial by conglomerates, students from the school groups chosen at random, from two high schools (one as a control group and another intervention) also chosen at random will be included. Adolescents who agree to participate will complete pre- and post-intervention assessments on fruit and vegetable consumption and ultra-processed foods. A multilevel analysis will be used to compare post-intervention variables between groups.


Recruitment information / eligibility

Status Completed
Enrollment 500
Est. completion date May 23, 2022
Est. primary completion date May 12, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 14 Years to 19 Years
Eligibility Inclusion Criteria: - Students enrolled in the included high schools (1st to 6th semester, morning and evening shift) - That they agree to participate and complete the assent and informed consent form Exclusion Criteria: - Students who do not wish to participate

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
ALIADA: Alimentación, Adolescencia y Ambiente
The objective of the educational nutritional intervention is to promote in adolescents an increase in their consumption of vegetables and fruits and a decrease in their consumption of ultra-processed foods, through the application of the TSC constructs, with the use of education by pairs as the main strategy (peer leaders). It lasts two months, includes three exclusive sessions for peer leaders and five sessions for all participants, where the leaders, together with the researchers, will lead the activities of the sessions, as well as a general event for all high school students. Intervention activities include: electronic presentations, videos, food preparation and label reading workshops, individual and team reflection activities, goal setting and monitoring, board games, contests, among others. In addition, each participant is given a workbook, which contains key messages and activities for each educational session.

Locations

Country Name City State
Mexico Upper Secondary Education System of the University of Guadalajara Guadalajara

Sponsors (1)

Lead Sponsor Collaborator
Centro Universitario de Ciencias de la Salud, Mexico

Country where clinical trial is conducted

Mexico, 

References & Publications (1)

McAlister AL, Perry CL, Parcel G. How individuals, environments and health behavior interact: social cognitive theory. In: Glanz K, Rimer BK, Viswanath K, eds. Health Behavior and Health Education: Theory, Research and Practice. 4°. Jossey-Bass A Wiley Imprint; 2008:169-188.

Outcome

Type Measure Description Time frame Safety issue
Primary Change in vegetables and fruits Pre-post intervention change in vegetable and fruit consumption (servings/day (direct values, no scores assigned), post intervention consumption minus pre intervention consumption, as measured by a semiquantitative food frequency questionnaire, positive values of change are desirable , that is, increased consumption of vegetables and fruits) 2 months
Primary Change in ultra-processed foods Pre-post intervention change in consumption of ultra-processed foods (servings/day (direct values, no scores assigned)), post intervention consumption minus pre intervention consumption, as measured by a semiquantitative food frequency questionnaire, negative values of change are desirable, that is, reduction in the consumption of ultra-processed foods) 2 months
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