Feeding Behavior Clinical Trial
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
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 |
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 |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Mexico | Upper Secondary Education System of the University of Guadalajara | Guadalajara |
Lead Sponsor | Collaborator |
---|---|
Centro Universitario de Ciencias de la Salud, Mexico |
Mexico,
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.
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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