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.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
176
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.
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
Time frame: 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
Time frame: 1 to 1.5 months, depending on the development of the patient and the completion of the 9 modules
Change in the Scale in Self- Efficacy Eating Consumption Scale (SEECS)
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).
Time frame: 1 to 1.5 months, depending on the development of the patient and the completion of the 9 modules
Change in the Self-Efficacy for Exercise Questionnaire (SEEQ)
The Self- Efficacy for 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).
Time frame: 1 to 1.5 months, depending on the development of the patient and the completion of the 9 modules
Change in the Sedentary behavior questionnarie (SBQ-s)
The SBQ-s has 11 items that assess the time spent on sedentary behaviors (e.g., watching television, eating while sitting, resting while lying down, driving or traveling by car, bus, or subway). These activities are evaluated on both a typical weekday and a weekend day. The response options are: "none," "15 minutes or less," "30 minutes," "1 hour," "2 hours," "3 hours," "4 hours," "5 hours," and "more than 6 hours." The time dedicated to each activity is converted into hours.
Time frame: 1 to 1.5 months, depending on the development of the patient and the completion of the 9 modules
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.
Time frame: 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 (GAD-7)
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
Time frame: 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 (CES-D)
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).
Time frame: 1 to 1.5 months, depending on the development of the patient and the completion of the 9 modules
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