Intervention Program Among University Student to Promote Physical Activity and Reduce the Sedentary Time

Study Overview
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Brief Summary
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Since the beginning of the COVID-19 pandemic, university students have faced many challenges and without any preparation. Studies conducted during the first lockdown show an increase in unhealthy lifestyles. This study will be proposed to students from University of Nimes an 8-week physical activity program. Two groups will be constituted: the first will benefit from of innovative physical activity program on the base of the co-construction with users (Experimental Group), another that will not benefit from any intervention (Control Group). Investigators plan to include approximately 90 university students, 45 in each group. The main goal of the study is to propose innovative program to promote PA (Physical Activity) and reduce ST (Sedentary Time) of young adults aged over 18 from university of Nîmes. The levels of PA and ST of the experimental group will be compared to a control group with the realization of pre and post intervention measures.

Detailed Description
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In March 2020, the World Health Organization declared the coronavirus disease 2019 (COVID-19) as a global pandemic. In France, all universities have been closed on 16th March 2020. In September 2020, face-to-face teaching restarted in French universities, but with new constraints (e.g., reducing number of students in classrooms, wearing masks) and significant changes in teachings (e.g., distance and/or hybrid education). In October 2020, several French universities closed down again due to significant contamination among students. Finally, on 30th October 2020, the French government imposed a second lockdown and all universities have been closed. It is only in February 2021 that face-to-face teaching started again in French universities (within the limit of 50% of the universities' capacity and 20% of the teachings). Since the beginning of the pandemic, university students have faced many challenges and without any preparation. Even before the pandemic, university students were identified as a population with unhealthy lifestyles and habits, notably reflected in high levels of sedentary behavior, low levels of physical activity and unhealthy diet. Studies conducted during the first lockdown have shown an increase in unhealthy lifestyles; The deleterious effects of the pandemic on students' health are now evident. However, some areas of research are still under-explored. The majority of research is largely descriptive and do not identify the factors involved in the deterioration of health To date, no interventional studies have been conducted to prevent the deterioration of students' health. Investigators expect a 9-week intervention. During the first week, a workshop of the co-construction with the users will be realized in order to remove the barriers to the practice of a physical activity. The aim of co-construction with users is to obtain better adherence to program, based on needs and not decided from above. Then, a group information session focusing on the promotion of active behaviors will be organize, and physical activities (moderate to vigorous) will be proposed for 8 weeks, twice a week. The main goal of the study is to propose innovative program to promote PA (Physical Activity) and reduce ST (Sedentary Time) of young adults aged over 18 from university of Nîmes. The levels of PA and ST of the experimental group will be compared to a control group with the realization of pre and post intervention measures.

Official Title
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Effects of an Intervention Among University Student to Promote Physical Activity and Reduce the Sedentary Time During COVID-19 Pandemic

Conditions
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Physical Activity, Sedentary Behavior, Young Adults, Student

Intervention / Treatment
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* Behavioral: University-based intervention to promote PA and reduce ST


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Students at the University of Nimes Exclusion Criteria: Physical diseases that prevent PA practice Depending on the evolution of sanitary conditions and governmental instructions in relation to COVID-19, the absence of a negative PCR test or vaccination may be a criterion for exclusion not to be a student of the University of Nîmes not signing the consent form to participate in the study

Ages Eligible for Study
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Minimum Age: 18 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: During the, baseline assessments were carried out in two groups (Experimental group, control group): measures of PA, ST, anthropometric data, sleep, physical condition and psychological variables (motivation, body appreciation, perceived control, well-being, …) These assessments were performed in October 2021 (First Time - T1) and December 2021 (Second time - T2). During the first academic semester, a university-based intervention to increase PA and reduce ST was realised in Experimental group.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: University-based 8-weeks intervention to promote Physical Activity (PA)<br>Experimental group: 8-weeks program of Physical Activity constructed by users during a design-based innovative workshops before the beginning of the interventions . | Behavioral: University-based intervention to promote PA and reduce ST<br>* This intervention was realized with all college student and involved: Design-based innovative workshops during the first week; 8-weeks program of Physical Activity constructed by users Information session focusing on the promotion of active behaviors Feedback provided to the users with an individualized report<br>|
| No Intervention: Control Group<br>Control group: No intervention, only two measurement times | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in level of physical activity (PA) | Physical activity, is measured with tri-axis accelerometers of the brand Actigraph model GT3X (Actilife, Pensacola, FL, USA). Data is collected every 10 seconds during 5 consecutive whole days. It is the most feasible and precise method for the purpose. | Baseline and post-intervention (8-week) | 
| Sedentary Time (ST) | Sedentary Time (ST), is measured with tri-axis accelerometers of the brand Actigraph model GT3X (Actilife, Pensacola, FL, USA). Data is collected every 10 seconds during 5 consecutive whole days. It is the most feasible and precise method for the purpose. | Baseline and post-intervention (8-week) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body fat | Body fat composition will be assessed trought a Bioelectrical Impedance Analysis method using a Tanita 780 MA-S Body Composition Analyser/Scale. Body fat is expressed as body fat mass (kg) and body fat percentage (%). | Baseline and post-intervention (8-week) | 
| Change in body muscle | Body muscle composition will be assessed trought a Bioelectrical Impedance Analysis method using a Tanita 780 MA-S Body Composition Analyser/Scale. Body muscle is expressed as body muscle mass (kg) and body muscle percentage (%). | Baseline and post-intervention (8-week) | 
| Change in body water | Body water composition will be assessed trought a Bioelectrical Impedance Analysis method using a Tanita 780 MA-S Body Composition Analyser/Scale. Body water is expressed as body water mass (kg) and body water percentage (%). | Baseline and post-intervention (8-week) | 
| Change in visceral fat rating | Visceral fat rating will be assessed trought a Bioelectrical Impedance Analysis method using a Tanita 780 MA-S Body Composition Analyser/Scale. Visceral fat rating is expressed on a scale from 1 to 60. A score between 1 and 12 is considering as healthy and a score between 12 to 60 is considering as excessive. | Baseline and post-intervention (8-week) | 
| Body Mass Index (BMI) | Height and weight will be measured by study staff at the baseline visit using a stadiometer (collecting height measures twice and reporting the average) and a calibrated scale TANITA 780 MA-S (light clothing, street shoes removed). BMI will be calculated as weight in kilograms divided by height in squared centimeters. Weight will be re-measured at 8 week. | Baseline and post-intervention (8-week) | 
| Changes in Physical Fitness : cardiovascular fitness | Participants complete a YMCA 3-minute step test for cardiovascular fitness (assessment of resting heart rate and recovery heart rate) | Baseline and post-intervention (8-week) | 
| Changes in Physical Fitness: flexibility | Participants complete a sit-and-reach test for flexibility | Baseline and post-intervention (8-week) | 
| Changes in Physical Fitness: strength upper limb. | Participants complete a grip strength test for strength of upper limb. Hand-grip strength measurement is made with a hydraulic hand-grip dynamometer. Hand-grip strength measurement is performed for the dominant hand when the elbow is close to the body, 90 degrees of flexion, and the wrist is in a neutral position. The measurement is repeated 3 times and the maximum value is recorded in kg. The dominant hand is determined by asking the participants with which hand they write. | Baseline and post-intervention (8-week) | 
| Changes in Physical Fitness: strength lower limb. | Participants complete a muscular lower limb strength test measured with the dynamometric chair LegControl V2. | Baseline and post-intervention (8-week) | 
| Quality of sleep, defined by number and duration of awakenings, and longest sustained sleep period for the study interval. | These data were measured by the Actigraph model GT3X (Actilife, Pensacola, FL, USA)and summarized as percentage of time spent sleeping, or sleep efficiency. Data is collected every 10 seconds during 5 consecutive whole days. | Baseline and post-intervention (8-week) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Physical Activity, Sedentary Behavior, student