Clinical trial NCT05834842: Online Intervention for Reduction of Ultra-processed Products and Increase of Physical Activity in University Students
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Physical Inactivity
Ultra Processed Food
Stress
Anxiety
Depression
Lead sponsor: University of Guadalajara
Sponsor class: OTHER
Collaborators: name: Universidad de Colima
First posted: 2023-04-28
Enrollment: 176
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study has two arms, one is the experimental group that receives the treatment and the other is the comparison group that will receive treatment after the 9 sessions of the experimental group finished. The patients in both groups will be evaluated pre and post/treatment. The participants are assigned randomly to the intervention or comparison group.
Primary purpose: TREATMENT

Brief 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.

Detailed 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

Eligibility criteria: 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.

Primary outcomes:
measure: Change in the scores of the Frequency of Consumption
timeFrame: 1 to 1.5 months, depending on the development of the patient and the completion of the 9 modules
measure: Change in time of the Physical Activity
timeFrame: 1 to 1.5 months, depending on the development of the patient and the completion of the 9 modules
measure: Change in the Scale in Self- Efficacy Eating Consumption Scale (SEECS)
timeFrame: 1 to 1.5 months, depending on the development of the patient and the completion of the 9 modules
measure: Change in the Self-Efficacy for Exercise Questionnaire (SEEQ)
timeFrame: 1 to 1.5 months, depending on the development of the patient and the completion of the 9 modules
measure: Change in the Sedentary behavior questionnarie (SBQ-s)
timeFrame: 1 to 1.5 months, depending on the development of the patient and the completion of the 9 modules
Secondary outcomes:
measure: Change in the Perceived Stress Scale
timeFrame: 1 to 1.5 months, depending on the development of the patient and the completion of the 9 modules
measure: Change in the Generalized Anxiety Disorder Scale (GAD-7)
timeFrame: 1 to 1.5 months, depending on the development of the patient and the completion of the 9 modules
measure: Change in the Center for Epidemiological Studies Depression Scale (CES-D)
timeFrame: 1 to 1.5 months, depending on the development of the patient and the completion of the 9 modules
Other outcomes:
Locations:
Study officials:
affiliation: ITLAS group
name: Alejandro Dominguez Rodriguez, PhD
role: STUDY_CHAIR
affiliation: University of Guadalajara
name: Itzel Refugio Alvarado-Ávalos, BD
role: STUDY_CHAIR
affiliation: Universidad de Colima
name: Fátima López-Alcaraz, PhD
role: STUDY_CHAIR
affiliation: University of Guadalajara
name: Estefania Gasca-Suarez, BD
role: STUDY_CHAIR
affiliation: University of Guadalajara
name: Adrian Antonio Cisneros-Hernández, PhD
role: STUDY_CHAIR
affiliation: University of Guadalajara
name: Alexandra Valadez, PhD
role: STUDY_CHAIR
affiliation: University of Guadalajara
name: Fabiola Macías-Espinoza, PhD
role: STUDY_CHAIR
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