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

University of Guadalajara

Status: Not yet enrolling

Conditions: Ultra Processed Food; Physical Inactivity; Depression; Anxiety; Stress

Treatments: Behavioral: Unisalud

Study type: Interventional

Funder types: Other

Identifiers

NCT05834842

UNISALUD

Details and patient eligibility

About

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.

Full 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

Enrollment: 176 estimated patients

Sex: All

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Have a device (cell phone, computer or tablet) with internet access.
• Have agreed to participate by giving tacit consent.
• Be enrolled in any degree from a university in Mexico

Exclusion criteria

• Be diagnosed with a psychiatric disorder.
• Being diagnosed with an eating disorder.
• Being under some nutritional food treatment.
• Have a physical disability or injury that prevents you from engaging in mild to moderate physical activity.
• Being under any pharmacological treatment for a medical condition.
• Leaving the instruments unfinished.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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176 participants in 2 patient groups

Behavioral: Online Intervention Unisalud

Experimental group

Description:

Participants in this group will receive 9 sessions of a multi-component intervention focused on the reduction of the consumption of ultra processed foods, symptoms of anxiety, depression and stress and the increase of physical activity.

Treatment:

Behavioral: Unisalud

No Intervention: Waiting List group

No Intervention group

Description:

The participants in this group will not receive the treatment, just waiting list. They will be measured one time and then a second time 3 months after. Calculating when 3 months corresponding to 9 sessions will receive the intervention.