- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05403060
Educational Nutritional Intervention for Adolescents
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 Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Guadalajara, Mexico
- Upper Secondary Education System of the University of Guadalajara
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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EXPERIMENTAL: Intervention
Educational nutritional intervention, based on the Social Cognitive Theory
|
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.
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NO_INTERVENTION: Control
Regular school education, without educational nutritional intervention
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in vegetables and fruits
Time Frame: 2 months
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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)
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2 months
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Change in ultra-processed foods
Time Frame: 2 months
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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)
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2 months
|
Collaborators and Investigators
Investigators
- Study Director: Gabriela Macedo Ojeda, PhD, Centro Universitario de Ciencias de la Salud, Universidad de Guadalajara
Publications and helpful links
General 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.
Helpful Links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 21-88
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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