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

Study Overview
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Brief Summary
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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
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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: Frequency of Consumption of ultra-processed foods International Physical Activity Questionnaire Health Action Process Approach Self-Efficacy Eating Consumption Scale Self-Efficacy Exercise Questionnaire Stress Perception Generalized Anxiety Disorder Scale The Center for Epidemiological Studies Depression Scale System Usability Scale

Official Title
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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

Conditions
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Physical Inactivity, Ultra Processed Food, Stress, Anxiety, Depression

Intervention / Treatment
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* Behavioral: Unisalud


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Behavioral: Online Intervention Unisalud<br>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. | Behavioral: Unisalud<br>* The UNISALUD intervention will be made up of 42 videos, made using the visual collage technique, where illustration, video fragments and visual interactions are mixed and in some there will be a presenter to achieve captivating visual material. to the participant. Likewise, it will be accompanied by digital infographics that will help reinforce the information proposed by the intervention.<br>|
| No Intervention: No Intervention: Waiting List group<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the scores of the Frequency of Consumption | To evaluate and monitor the consumption of PUs, a Consumption Frequency with emphasis on processing will be used, which was adapted from the Nova screener for the consumption of ultra-processed foods and the Consumption Frequency of foods of adolescents and adults (12 years or older), used in the National Health and Nutrition Survey, 2019, which shows the foods commonly consumed in Mexico. This is a qualitative instrument that evaluates the consumption of PUs in three categories: a) drinks (12 items); b) products that replace or accompany meals (26 items); and c) unhealthy snacks (12 items). Intake is reported on a previous day (yes or no) and in frequency of consumption per month (never, once a month, once every 15 days, and 1 to 7 times a week or more than once a day). The cut-off points were delimited based on previous studies: a) High consumption: 5 or more products per day, b) Medium consumption: between 2 and 4 products per day and c) Low one or non products | 1 to 1.5 months, depending on the development of the patient and the completion of the 9 modules | 
| Change in time of the Physical Activity | The short version of International Physical Activity questionnarie consists of 7 items and provides information about the time the person spends doing moderate and vigorous intensity activities, walking, and sitting in the last seven days. The questionnaire classifies the level of activity carried out into three categories: low, moderate and high | 1 to 1.5 months, depending on the development of the patient and the completion of the 9 modules | 
| Change in the Scale of Self-Efficacy for Eating Consumption | Self-Efficacy Eating consumption Scale, consisted of 21 items with a response option ranging from 1 to 10, where 1 represents the absence of capacity and 10 represents being very capable of reducing the intake of caloric products or sweets and change the consumption of healthy foods. In addition, they were asked if they engaged in any type of physical activity. This scale shows reliability criteria of (α = 0.93). | 1 to 1.5 months, depending on the development of the patient and the completion of the 9 modules | 
| Change in the Self-Efficacy Exercise | The Self- Efficacy Exercise Questionnaire assesses the degree of confidence that people perceive to be physically active. The full scale is composed of 5 items that assess negative affect, resistance to relapse, and giving oneself time to be physically active. It is Likert-type and its response options range from 1 (not at all confident) to 5 (extremely confident). | 1 to 1.5 months, depending on the development of the patient and the completion of the 9 modules | 
| Change in the Sedentary Behavior Risk Perception Scale | The Scale of Perception of Risk of Sedentary Behaviors, designed ad hoc for this study, this scale is a self-report with which the level of risk perception of sedentary behaviors is evaluated. It consists of four items with six response options that are: 1 = Totally disagree, 2 = Strongly disagree, 3 = Slightly disagree, 4 = Somewhat agree, 5 = Very much. agree, 6 = Totally agree. The direct score obtained indicates that a higher score corresponds to a higher level of risk perception. | 1 to 1.5 months, depending on the development of the patient and the completion of the 9 modules | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Perceived Stress Scale | Culturally the Perceive Stress Scale it has been adapted in Mexico by González-Ramírez & Landero-Hernández (2007). It is a Likert-type of 14 items with response options to 0 (never) to 4 (very often) to evaluate the degree to which situations in one's life are appraised as stressful. | 1 to 1.5 months, depending on the development of the patient and the completion of the 9 modules | 
| Change in the Generalized Anxiety Disorder Scale | It is Likert-type of seven ítems and its response options range from 0 (not at all) - 3 (nearly every day). A score between 0 and 3 points indicates no perceived anxiety, and a score between 15 and 21 is an indicator of severe perceived anxiety | 1 to 1.5 months, depending on the development of the patient and the completion of the 9 modules | 
| Change in the Center for Epidemiological Studies Depression Scale | It was designed based on the study of clinical and general populations, and is currently one of the most widely used to assess depressive symptomatology in clinical and research settings at international and national level. It consists of 35 questions and contains five possible answers ranging from Scarcely (0 to 1 day), Somewhat (1-2 days), Occasionally (3-4 days), Most (5-7 days) and Almost daily (10-14 days). | 1 to 1.5 months, depending on the development of the patient and the completion of the 9 modules |