Online Intervention for Reduction of Ultra-processed Products and Increase of Physical Activity in University Students — UNISALUD  

Depression Clinical Trial

Official title: An Internet-based Self-help Intervention for the Reduction of Consumption of Ultra-processed Products and Increase of Physical Activity in Mexican University Population: Study Protocol for a Randomized Controlled Trial

Status Not yet recruiting

Clinical Trial Summary

This study evaluates the effectiveness of an online Multi-component psychological intervention, that is focused on reducing the consumption of ultra processed foods and increase the frequency of performing Physical Activity. At the same time to observe the effect on symptoms of anxiety, depression and stress.

Clinical Trial Description

Ultra Processed Products are edible products made primarily or entirely from substances derived from food. Its manufacture is based on industrial processes such as hydrogenation, extrusion and molding, pre-processed for frying, and that cannot be done at home. A sedentary lifestyle or physical inactivity is associated with loss of muscle mass and weight gain. In contrast, physical activity acts as a protector against non-communicable diseases such as type 2 diabetes, cardiovascular diseases and some types of cancer. AF levels are determined through Units of Measurement of the Metabolic Rate. Also the consumption of Ultra Processed Products and sedentary behaviors have been associated with affectations on people's health; An example of this is the association that exists between them and has been associated with an increased risk of suffering from depression, anxiety, and stress.

Internet-based interventions had a large effect on cognitive dietary outcomes, a moderate effect on dietary intake and weight, and a small effect on physical activity outcomes. In concrete, self-applied interventions can be an option to arrive at a great number of participants. In such intervention the user receives the treatment solely through a web platform or an App. Such interventions are usually composed of videos, text and audios. Different reviews regarding self-administered treatments via the internet and computer-based treatments have been found them to be effective to achieve their goals.

The intervention will follow the principles of User Experience, with this ensuring that the design characteristics of the tool will meet the desired requirements to be perceived as easy to use, attractive and useful.

This study will be conducted through a randomized controlled clinical superiority trial with two independent groups. It will include intra subjects at five evaluation moments: 1) pretest, 2) middle of the intervention, 3) post-test, 4) follow up at three months and 5) follow up at 6 months.

Participants will be randomly assigned to one of two groups: experimental group, "UNISALUD", composed of 9 sessions and interactive elements such as videos, audios and infographics; control group, will be the waiting list group, the participants in this group will not receive the treatment immediately, it will be measured one time and then a second time 27 days later than the experimental group when it is calculated that the first group has carried out the 9 sessions.

The measures will be the following:

1. Frequency of Consumption of ultra-processed foods

2. International Physical Activity Questionnaire

3. Health Action Process Approach

4. Self-Efficacy Eating Consumption Scale

5. Self-Efficacy Exercise Questionnaire

6. Stress Perception

7. Generalized Anxiety Disorder Scale

8. The Center for Epidemiological Studies Depression Scale

9. System Usability Scale ;

Related Conditions & MeSH terms

• Anxiety
• Depression
• Physical Inactivity
• Stress

• NCT number: NCT05834842
• Study type: Interventional
• Source: University of Guadalajara
• Contact: Leyna Priscila Lopez Torres, PhD
• Phone: +52 10505200
• Email: priscila.lopez@academicos.udg.mx
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2024
• Completion date: December 31, 2025