Ignite Creation Date:
2024-05-06 @ 6:55 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05834842
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-26
First Post:
2023-04-17
Brief Title:
Online Intervention for Reduction of Ultra-processed Products and Increase of Physical Activity in University Students
Sponsor:
University of Guadalajara
Organization:
University of Guadalajara
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
UNISALUD
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 peoples 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None