Educational Nutritional Intervention for Adolescents

Sponsor

Centro Universitario de Ciencias de la Salud, Mexico (Other)

Overall Status

Completed

CT.gov ID

NCT05403060

Collaborator

(none)

500

Enrollment

Location

Arms

2.7

Actual Duration (Months)

183.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Early Intervention, Educational Health Promotion Feeding Behavior Adolescent Health	Behavioral: ALIADA: Alimentación, Adolescencia y Ambiente	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

500 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

An intervention group and a control group (no intervention, with usual education)An intervention group and a control group (no intervention, with usual education)

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Educational Nutritional Intervention to Increase the Consumption of Vegetables and Fruits and Decrease the Consumption of Ultra-processed Foods in Adolescents: Randomized Controlled Trial by Conglomerates

Actual Study Start Date :

Mar 1, 2022

Actual Primary Completion Date :

May 12, 2022

Actual Study Completion Date :

May 23, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Educational nutritional intervention, based on the Social Cognitive Theory	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.
No Intervention: Control Regular school education, without educational nutritional intervention

Arm

Intervention/Treatment

Experimental: Intervention

Educational nutritional intervention, based on the Social Cognitive Theory

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.

No Intervention: Control

Regular school education, without educational nutritional intervention

Outcome Measures

Primary Outcome Measures

Change in vegetables and fruits [2 months]
Pre-post intervention change in the consumption of vegetables and fruits (servings/day, measured by a semi-quantitative food frequency questionnaire)
Change in ultra-processed foods [2 months]
Pre-post intervention change in the consumption of ultra-processed foods (servings/day, measured by a semi-quantitative food frequency questionnaire)

Eligibility Criteria

Criteria

Ages Eligible for Study:

14 Years to 19 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Upper Secondary Education System of the University of Guadalajara	Guadalajara		Mexico

Sponsors and Collaborators

Centro Universitario de Ciencias de la Salud, Mexico

Investigators

Study Director: Gabriela Macedo Ojeda, PhD, Centro Universitario de Ciencias de la Salud, Universidad de Guadalajara

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Encuesta Nacional de Salud y Nutrición 2018

Publications

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.

Responsible Party:

Gabriela Macedo Ojeda, PhD in Public Health Sciences, Centro Universitario de Ciencias de la Salud, Mexico

ClinicalTrials.gov Identifier:

NCT05403060

Other Study ID Numbers:

21-88

First Posted:

Jun 3, 2022

Last Update Posted:

Jun 3, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Gabriela Macedo Ojeda, PhD in Public Health Sciences, Centro Universitario de Ciencias de la Salud, Mexico

Vegetables

Fruit

Ultra-processed Food

Study Results

No Results Posted as of Jun 3, 2022