Clinical trial NCT05019482: Intervention Program Among University Student to Promote Physical Activity and Reduce the Sedentary Time
Official title: Effects of an Intervention Among University Student to Promote Physical Activity and Reduce the Sedentary Time During COVID-19 Pandemic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Sedentary Behavior
Young Adults
Student
Keywords: Physical Activity
Sedentary Behavior
student
Lead sponsor: University of Nimes
Sponsor class: OTHER
First posted: 2021-08-24
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

Brief summary: 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: 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.

1. The majority of research is largely descriptive and do not identify the factors involved in the deterioration of health
2. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in level of physical activity (PA)
timeFrame: Baseline and post-intervention (8-week)
measure: Sedentary Time (ST)
timeFrame: Baseline and post-intervention (8-week)
Secondary outcomes:
measure: Change in body fat
timeFrame: Baseline and post-intervention (8-week)
measure: Change in body muscle
timeFrame: Baseline and post-intervention (8-week)
measure: Change in body water
timeFrame: Baseline and post-intervention (8-week)
measure: Change in visceral fat rating
timeFrame: Baseline and post-intervention (8-week)
measure: Body Mass Index (BMI)
timeFrame: Baseline and post-intervention (8-week)
measure: Changes in Physical Fitness : cardiovascular fitness
timeFrame: Baseline and post-intervention (8-week)
measure: Changes in Physical Fitness: flexibility
timeFrame: Baseline and post-intervention (8-week)
measure: Changes in Physical Fitness: strength upper limb.
timeFrame: Baseline and post-intervention (8-week)
measure: Changes in Physical Fitness: strength lower limb.
timeFrame: Baseline and post-intervention (8-week)
measure: Quality of sleep, defined by number and duration of awakenings, and longest sustained sleep period for the study interval.
timeFrame: Baseline and post-intervention (8-week)
Other outcomes:
measure: Changes in Physical Activity as measured by the International Physical Activity - Short Form (IPAQ-SF)
timeFrame: Baseline and post-intervention (8-week)
measure: Changes in motivation
timeFrame: Baseline and post-intervention (8-week)
measure: Changes in sleep quality (PSQI)
timeFrame: Baseline and post-intervention (8-week)
measure: Changes in body image (BAS-2)
timeFrame: Baseline and post-intervention (8-week)
measure: Changes in eating behaviors (EAT-26)
timeFrame: Baseline and post-intervention (8-week)
measure: Changes in Anxiety and depressive symptoms (HADS)
timeFrame: Baseline and post-intervention (8-week)
measure: Changes in social support (SPS-10)
timeFrame: Baseline and post-intervention (8-week)
measure: Changes in well-being
timeFrame: Baseline and post-intervention (8-week)
measure: Changes in perceived fatigue (MFI-20)
timeFrame: Baseline and post-intervention (8-week)
measure: Changes in perceived control (PSMS)
timeFrame: Baseline and post-intervention (8-week)
measure: Situational factors
timeFrame: Baseline and post-intervention (8-week)
measure: Socio-demographic factors
timeFrame: Baseline
Locations:
city: Nîmes Cedex 1
country: France
facility: Universite de Nimes
Study officials:
affiliation: UNIVERSITE DE NIMES - UPR APSY-v
name: ELODIE CHARBONNIER, PhD
role: STUDY_DIRECTOR
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