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

NCT05834842 | Not Yet Recruiting DMC

• 1 other identifier: UNISALUD
• Study Type: interventional
• Target: 176
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (5)

• 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 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).

  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).

  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.

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

Secondary Outcomes (3)

• Change in the Perceived Stress Scale

  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)

  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)

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

Study Arms (2)

Behavioral: Online Intervention Unisalud

EXPERIMENTAL

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

No Intervention: Waiting List group

NO INTERVENTION

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.

Interventions

Unisalud BEHAVIORAL

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.

Behavioral: Online Intervention Unisalud

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Guadalajara: lead
• Universidad de Colima: collaborator

Related Publications (13)

• 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.

  PMID: 32428295 BACKGROUND

• 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.

  PMID: 31181143 BACKGROUND

• 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.

  PMID: 35721795 BACKGROUND

• 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.

  PMID: 34444936 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 31975312 BACKGROUND

• 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.

  PMID: 24006016 RESULT

• 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.

  RESULT

• 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.

  PMID: 1574662 RESULT

• 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.

  PMID: 17549893 RESULT

• 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.

  PMID: 16717171 RESULT

• 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.

  PMID: 18670720 RESULT

• 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.

  PMID: 39221160 DERIVED

MeSH Terms

Conditions

Sedentary Behavior; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Behavior; Mental Disorders; Behavioral Symptoms

Study Officials

• Alejandro Dominguez Rodriguez, PhD

  ITLAS group

  STUDY CHAIR

• Itzel Refugio Alvarado-Ávalos, BD

  University of Guadalajara

  STUDY CHAIR

• Fátima López-Alcaraz, PhD

  Universidad de Colima

  STUDY CHAIR

• Estefania Gasca-Suarez, BD

  University of Guadalajara

  STUDY CHAIR

• Adrian Antonio Cisneros-Hernández, PhD

  University of Guadalajara

  STUDY CHAIR

• Alexandra Valadez, PhD

  University of Guadalajara

  STUDY CHAIR

• Fabiola Macías-Espinoza, PhD

  University of Guadalajara

  STUDY CHAIR

Central Study Contacts

Leyna Priscila Lopez Torres, PhD

CONTACT

+52 10505200; priscila.lopez@academicos.udg.mx

Joel Omar González Cantero, PhD

CONTACT

+52 10585200; joel.gonzalez@academicos.udg.mx

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The patients are not aware that there is an experimental group and a control group, the participants are not related and do not know each other. The conditions of the study are only known by the researcher, the therapists, and the Research Ethics Committee of the Universidad de Guadalajara.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 17, 2023
• First Posted: April 28, 2023
• Study Start: September 1, 2024
• Primary Completion: March 30, 2025
• Study Completion: December 31, 2025
• Last Updated: March 26, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF
• Time Frame: This data will be available approximately in February 2024 and it will be permanently available. It will be shared in the databases of the journal where the article(s) will be published.
• Access Criteria: Through the servers of the journal(s) where we will publish the articles.