NCT05403060

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2022

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 24, 2022

Completed
5 days until next milestone

Study Start

First participant enrolled

March 1, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 12, 2022

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 23, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 3, 2022

Completed
Last Updated

February 9, 2023

Status Verified

February 1, 2023

Enrollment Period

2 months

First QC Date

February 24, 2022

Last Update Submit

February 7, 2023

Conditions

Keywords

VegetablesFruitUltra-processed Food

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

Intervention

EXPERIMENTAL

Educational nutritional intervention, based on the Social Cognitive Theory

Behavioral: ALIADA: Alimentación, Adolescencia y Ambiente

Control

NO INTERVENTION

Regular school education, without educational nutritional intervention

Interventions

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.

Intervention

Eligibility Criteria

Age14 Years - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Students who do not wish to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Upper Secondary Education System of the University of Guadalajara

Guadalajara, Mexico

Location

Related 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.

    BACKGROUND

Related Links

MeSH Terms

Conditions

Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Study Officials

  • Gabriela Macedo Ojeda, PhD

    Centro Universitario de Ciencias de la Salud, Universidad de Guadalajara

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: An intervention group and a control group (no intervention, with usual education)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD in Public Health Sciences

Study Record Dates

First Submitted

February 24, 2022

First Posted

June 3, 2022

Study Start

March 1, 2022

Primary Completion

May 12, 2022

Study Completion

May 23, 2022

Last Updated

February 9, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations