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Physical InactivityUNISALUDNCT05834842

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

A study testing Unisalud in people with Physical Inactivity and Ultra Processed Food, run by University of Guadalajara.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 35 yearsHealthy volunteers can take part
Conditions the study is for
Physical Inactivity, Ultra Processed Food, Stress
What is being tested?
Unisalud
Could I receive a placebo?
No, everyone receives an active treatment
How many people
176 participants
Where
No sites listed yet
Study dates
1 Sep 2024to 31 Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

No sites are listed yet.

Leyna Priscila Lopez Torres, PhD contact

+52 10505200 ext. 33684

priscila.lopez@academicos.udg.mx

Joel Omar González Cantero, PhD contact

+52 10585200 ext. 33684

joel.gonzalez@academicos.udg.mx

About this study

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

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.

Read the 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
Being tested
Unisalud
Medical subject headings
Sedentary Behavior, Anxiety Disorders, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • UnisaludBehavioural

    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.

Study groups in NCT05834842
Study groupRoleWhat they receive
Behavioral: Online Intervention UnisaludExperimentalParticipants 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.
Receives: Behavioral: Unisalud
No Intervention: Waiting List groupNo interventionThe 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 1 to 1.5 months, depending on the development of the patient and the completion of the 9 modules

  2. 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

    Measured: 1 to 1.5 months, depending on the development of the patient and the completion of the 9 modules

  3. 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).

    Measured: 1 to 1.5 months, depending on the development of the patient and the completion of the 9 modules

  4. 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).

    Measured: 1 to 1.5 months, depending on the development of the patient and the completion of the 9 modules

  5. 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.

    Measured: 1 to 1.5 months, depending on the development of the patient and the completion of the 9 modules

Secondary outcomes (3)

  1. 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.

    Measured: 1 to 1.5 months, depending on the development of the patient and the completion of the 9 modules

  2. 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

    Measured: 1 to 1.5 months, depending on the development of the patient and the completion of the 9 modules

  3. 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).

    Measured: 1 to 1.5 months, depending on the development of the patient and the completion of the 9 modules

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Apr 2023
  2. Study start1 Sep 2024 (estimated)
  3. Primary completion30 Mar 2025 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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 blind
Who is masked
Participant
Enrolment
176 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05834842
Sponsor's protocol ID
UNISALUD
Acronym
UNISALUD
Status last verified
Mar 2024
First submitted
17 Apr 2023
Last updated
26 Mar 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The information will be available in a private server or in a server of the journal(s) that we will publish the articles that will be the result of this study. The protocol of the study is currently in progress to be published, in this article will be included such study protocol, the informed consent is already shared in the register of clinical trials.

Publications

  • Bhutani S, Cooper JA. COVID-19-Related Home Confinement in Adults: Weight Gain Risks and Opportunities. Obesity (Silver Spring). 2020 Sep;28(9):1576-1577. doi: 10.1002/oby.22904. Epub 2020 Aug 6. No abstract available.

    PubMed 32428295

  • Belogianni K, Baldwin C. Types of Interventions Targeting Dietary, Physical Activity, and Weight-Related Outcomes among University Students: A Systematic Review of Systematic Reviews. Adv Nutr. 2019 Sep 1;10(5):848-863. doi: 10.1093/advances/nmz027.

    PubMed 31181143

  • Dominguez-Rodriguez A, De La Rosa-Gomez A. A Perspective on How User-Centered Design Could Improve the Impact of Self-Applied Psychological Interventions in Low- or Middle-Income Countries in Latin America. Front Digit Health. 2022 Jun 2;4:866155. doi: 10.3389/fdgth.2022.866155. eCollection 2022.

    PubMed 35721795

  • Marino M, Puppo F, Del Bo' C, Vinelli V, Riso P, Porrini M, Martini D. A Systematic Review of Worldwide Consumption of Ultra-Processed Foods: Findings and Criticisms. Nutrients. 2021 Aug 13;13(8):2778. doi: 10.3390/nu13082778.

    PubMed 34444936

  • López-Torres, L. P., & López-Alcaraz, F. (2022). Los productos ultra-procesados: Implicancias sobre su consumo, avances y retos en América Latina para la salud pública en adultos (Ultra-processed products: Implications for their consumption, advances and challenges in Latin America for public health in adults). Revista chilena de nutrición, 49(5), 637-643.

  • Castro O, Bennie J, Vergeer I, Bosselut G, Biddle SJH. How Sedentary Are University Students? A Systematic Review and Meta-Analysis. Prev Sci. 2020 Apr;21(3):332-343. doi: 10.1007/s11121-020-01093-8.

    PubMed 31975312

  • Medina C, Barquera S, Janssen I. Validity and reliability of the International Physical Activity Questionnaire among adults in Mexico. Rev Panam Salud Publica. 2013 Jul;34(1):21-8.

    PubMed 24006016

  • Palacios, J., Ramírez, V., Anaya, M., Hernández, H. L., & Martínez, R. (2017). Evaluación psicométrica de una escala de autoeficacia de la conducta alimentaria (Psychometric evaluation of a self-efficacy scale of eating behavior). Revista chilena de nutrición, 44(1), 95-102.

  • Marcus BH, Selby VC, Niaura RS, Rossi JS. Self-efficacy and the stages of exercise behavior change. Res Q Exerc Sport. 1992 Mar;63(1):60-6. doi: 10.1080/02701367.1992.10607557.

    PubMed 1574662

  • Ramirez MT, Hernandez RL. Factor structure of the Perceived Stress Scale (PSS) in a sample from Mexico. Span J Psychol. 2007 May;10(1):199-206. doi: 10.1017/s1138741600006466.

    PubMed 17549893

  • Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.

    PubMed 16717171

  • Gonzalez-Forteza C, Jimenez-Tapia JA, Ramos-Lira L, Wagner FA. [Application of the revised version of the Center of Epidemiological Studies Depression Scale in adolescent students from Mexico City]. Salud Publica Mex. 2008 Jul-Aug;50(4):292-9. doi: 10.1590/s0036-36342008000400007. Spanish.

    PubMed 18670720

  • Gonzalez-Cantero JO, Lopez-Torres LP, Alvarado-Avalos IR, Lopez-Alcaraz F, Gasca-Suarez E, Cisneros-Hernandez AA, Valadez A, Macias-Espinoza F, Dominguez-Rodriguez A. 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. Front Nutr. 2024 Jul 29;11:1325528. doi: 10.3389/fnut.2024.1325528. eCollection 2024.

    PubMed 39221160

Questions about this trial

What is this clinical trial studying?

A study testing Unisalud in people with Physical Inactivity and Ultra Processed Food, run by University of Guadalajara.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 26 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Leyna Priscila Lopez Torres, PhD (+52 10505200 ext. 33684, priscila.lopez@academicos.udg.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in the scores of the Frequency of Consumption (time frame: 1 to 1.5 months, depending on the development of the patient and the completion of the 9 modules). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05834842, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2024.

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