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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05019482
Recruitment Status : Completed
First Posted : August 24, 2021
Last Update Posted : June 29, 2022
Sponsor:
Information provided by (Responsible Party):
aurelie goncalves, University of Nimes

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.


Condition or disease Intervention/treatment Phase
Physical Activity Sedentary Behavior Young Adults Student Behavioral: University-based intervention to promote PA and reduce ST Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.

Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effects of an Intervention Among University Student to Promote Physical Activity and Reduce the Sedentary Time During COVID-19 Pandemic
Actual Study Start Date : September 6, 2021
Actual Primary Completion Date : December 17, 2021
Actual Study Completion Date : December 17, 2021


Arm Intervention/treatment
Experimental: University-based 8-weeks intervention to promote Physical Activity (PA)
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

This intervention was realized with all college student and involved:

  1. Design-based innovative workshops during the first week;
  2. 8-weeks program of Physical Activity constructed by users
  3. Information session focusing on the promotion of active behaviors
  4. Feedback provided to the users with an individualized report

No Intervention: Control Group
Control group: No intervention, only two measurement times



Primary Outcome Measures :
  1. Change in level of physical activity (PA) [ Time Frame: Baseline and post-intervention (8-week) ]
    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.

  2. Sedentary Time (ST) [ Time Frame: Baseline and post-intervention (8-week) ]
    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.


Secondary Outcome Measures :
  1. Change in body fat [ Time Frame: Baseline and post-intervention (8-week) ]

    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 (%).


  2. Change in body muscle [ Time Frame: Baseline and post-intervention (8-week) ]

    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 (%).


  3. Change in body water [ Time Frame: Baseline and post-intervention (8-week) ]

    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 (%).


  4. Change in visceral fat rating [ Time Frame: Baseline and post-intervention (8-week) ]

    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.


  5. Body Mass Index (BMI) [ Time Frame: Baseline and post-intervention (8-week) ]

    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.


  6. Changes in Physical Fitness : cardiovascular fitness [ Time Frame: Baseline and post-intervention (8-week) ]
    Participants complete a YMCA 3-minute step test for cardiovascular fitness (assessment of resting heart rate and recovery heart rate)

  7. Changes in Physical Fitness: flexibility [ Time Frame: Baseline and post-intervention (8-week) ]
    Participants complete a sit-and-reach test for flexibility

  8. Changes in Physical Fitness: strength upper limb. [ Time Frame: Baseline and post-intervention (8-week) ]

    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.


  9. Changes in Physical Fitness: strength lower limb. [ Time Frame: Baseline and post-intervention (8-week) ]
    Participants complete a muscular lower limb strength test measured with the dynamometric chair LegControl V2.

  10. Quality of sleep, defined by number and duration of awakenings, and longest sustained sleep period for the study interval. [ Time Frame: Baseline and post-intervention (8-week) ]
    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.


Other Outcome Measures:
  1. Changes in Physical Activity as measured by the International Physical Activity - Short Form (IPAQ-SF) [ Time Frame: Baseline and post-intervention (8-week) ]

    Subjective physical activity and sitting time over the last 7 days are measured.

    Measurements are made before and after the intervention, using an online questionnaire (made on qualtrics secure software).


  2. Changes in motivation [ Time Frame: Baseline and post-intervention (8-week) ]

    Motivation is assessed with he motivation scale towards health-oriented physical activity in french.

    Measurements are made before and after the intervention, using an online questionnaire (made on qualtrics secure software).


  3. Changes in sleep quality (PSQI) [ Time Frame: Baseline and post-intervention (8-week) ]

    Assessment of sleep quality is measured with the French adaptation of Pittsburgh Sleep Quality Index (PSQI). It is a simple tool which assess the sleep quality over one month period. It included seven components with a global PSQI score > 5 is indicative of poor sleep quality

    Measurements are made before and after the intervention, using an online questionnaire (made on qualtrics secure software).


  4. Changes in body image (BAS-2) [ Time Frame: Baseline and post-intervention (8-week) ]

    Assessment of body image measured with the Body Appreciation Scale-2 (BAS-2). The scale comprises 10 items rated on a 5-point scale, ranging from 1 (Never) to 5 (Always), with higher total scoring indicating more positive body appreciation.

    Measurements are made before and after the intervention, using an online questionnaire (made on qualtrics secure software).


  5. Changes in eating behaviors (EAT-26) [ Time Frame: Baseline and post-intervention (8-week) ]

    Assessment of eating behaviour measured with the eating Attitudes Test (EAT-26).

    The EAT-26 is a self-administered questionnaire that reveals abnormal eating behaviors. It consists of 26 items with six components scored from 0 to 3 (Zero: "Never," "Rarely," and "Sometimes"; 1: "Often"; 2: "Very often"; and 3: "Always"). The total score range from 0 to 78, and a score ≥ 20 is considered to represent abnormal eating attitudes or behaviors

    Measurements are made before and after the intervention, using an online questionnaire (made on qualtrics secure software).


  6. Changes in Anxiety and depressive symptoms (HADS) [ Time Frame: Baseline and post-intervention (8-week) ]

    Assessment of anxiety and depressive symptoms measured with the Hospital Anxiety and Depression Scale (HADS).

    These symptoms are assessed using a French version of the HADS. This 14-item self-report questionnaire assesses anxiety symptoms and depressive symptoms (7 items for each dimension) with labels varying from one item to the next. Scores range from 0 to 21 for each dimension, with higher scores reflecting higher levels of anxiety or depressive symptoms.

    Measurements are made before and after the intervention, using an online questionnaire (made on qualtrics secure software).


  7. Changes in social support (SPS-10) [ Time Frame: Baseline and post-intervention (8-week) ]

    Assessment of social support measured with the french validation of the Social Provisions Scale-10 item

    The 10 items are rated on a 4-point Likert scale ranging from 1 ("strongly disagree") to 4 ("Strongly in agreement").

    This self-report scale capturing five dimensions of social support (two items per dimension of support): emotional support or attachment (e.g., "I feel a strong emotional bond with at least one other person"), social integration (e.g., "there are people who enjoy the same social activities I do"), reassurance of worth (e.g., "there are people who admire my talents and skills"), tangible help (e.g., "there are people I can count on to help me when I really need it"), and orientation (e.g., "there is someone with whom I can discuss important decisions about my life").

    Measurements are made before and after the intervention, using an online questionnaire (made on qualtrics secure software).


  8. Changes in well-being [ Time Frame: Baseline and post-intervention (8-week) ]

    Assessment of well-being is evaluated with the French validation of the psychological Well-Being Scale. The 18 items are rated on a 6-point Likert scale ranging from 1 ("Disagreement") to 6 ("Agreement"). This self-report scale capturing six components of weel-being (three items per components): autonomy, control of the environment, personal development, positive relationships, giving meaning to life and self-acceptance.

    Measurements are made before and after the intervention, using an online questionnaire (made on qualtrics secure software).


  9. Changes in perceived fatigue (MFI-20) [ Time Frame: Baseline and post-intervention (8-week) ]

    Assessment of perceived fatigue is evaluated with the French validation of the Multidimensional Fatigue Inventory (MFI-20)

    A self-report instrument of five dimensions of fatigue. General fatigue, physical fatigue, mental fatigue, reduced activity and reduced motivation.

    Measurements are made before and after the intervention, using an online questionnaire (made on qualtrics secure software).


  10. Changes in perceived control (PSMS) [ Time Frame: Baseline and post-intervention (8-week) ]

    Assessment of well-being is evaluated with the French validation of the the Pearlin Self-Mastery Scale Perceived control with scores range up to 28, higher scores = higher mastery

    Measurements are made before and after the intervention, using an online questionnaire (made on qualtrics secure software).


  11. Situational factors [ Time Frame: Baseline and post-intervention (8-week) ]

    Investigators considered six situational factors:

    1. the extent to which participants felt that lockdown was compromising their future job prospects (scale ranging from 0 to 100)
    2. the extent to which university studies were essential to participants (scale ranging from 0 to 100)
    3. the presence or absence of COVID symptoms (dichotomous answer: Yes or No)
    4. the presence or absence of COVID symptoms in their relatives (dichotomous answer: Yes or No)
    5. participants' level of concern about their health owing to the COVID-19 crisis (scale ranging from 0 to 100)
    6. participants' level of concern about their relatives' health owing to the COVID-19 crisis (scale ranging from 0 to 100).

    Measurements are made before and after the intervention, using an online questionnaire (made on qualtrics secure software).


  12. Socio-demographic factors [ Time Frame: Baseline ]

    Investigators considered four socio-demographic factors:

    1. Age
    2. Gender
    3. Level of education
    4. Field of study

    Measurements are made before and after the intervention, using an online questionnaire (made on qualtrics secure software).




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05019482


Locations
Layout table for location information
France
Universite de Nimes
Nîmes Cedex 1, France, 30021
Sponsors and Collaborators
University of Nimes
Investigators
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Study Director: ELODIE CHARBONNIER, PhD UNIVERSITE DE NIMES - UPR APSY-v
Publications of Results:
Other Publications:
Charbonnier, E., Le Vigouroux, S., & Goncalves, A. (2021). Etudiants en temps de confinement et au-delà. La Presse Médicale Formation. https://doi.org/10.1016/j.lpmfor.2021.06.011

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: aurelie goncalves, Associate professor, University of Nimes
ClinicalTrials.gov Identifier: NCT05019482    
Other Study ID Numbers: UNimes.2
First Posted: August 24, 2021    Key Record Dates
Last Update Posted: June 29, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by aurelie goncalves, University of Nimes:
Physical Activity
Sedentary Behavior
student