Clinical trial NCT05403060: Educational Nutritional Intervention for Adolescents
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Early Intervention, Educational
Health Promotion
Feeding Behavior
Adolescent Health
Keywords: Vegetables
Fruit
Ultra-processed Food
Lead sponsor: Centro Universitario de Ciencias de la Salud, Mexico
Sponsor class: OTHER
First posted: 2022-06-03
Enrollment: 500
Sex: ALL
Minimum age (years): 14
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: An intervention group and a control group (no intervention, with usual education)
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in vegetables and fruits
timeFrame: 2 months
measure: Change in ultra-processed foods
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: Upper Secondary Education System of the University of Guadalajara
Study officials:
affiliation: Centro Universitario de Ciencias de la Salud, Universidad de Guadalajara
name: Gabriela Macedo Ojeda, PhD
role: STUDY_DIRECTOR
References:
citation: 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.