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Physical ActivityNCT05019482

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

A study testing University-based intervention to promote PA and reduce ST in people with Physical Activity and Sedentary Behavior, run by University of Nimes at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
University-based intervention to promote PA and reduce ST
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
1 siteFrance
Study dates
6 Sep 2021to 17 Dec 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Students at the University of Nimes

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

France1 site

  • Universite de Nimes

    Nîmes, 30021

Other trials in France

About this study

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

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.

Read the 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.

Being tested
University-based intervention to promote PA and reduce ST
Keywords
Physical Activity, Sedentary Behavior, student
Medical subject headings
Motor Activity, Sedentary Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • University-based intervention to promote PA and reduce STBehavioural

    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
Study groups in NCT05019482
Study groupRoleWhat they receive
University-based 8-weeks intervention to promote Physical Activity (PA)ExperimentalExperimental group: 8-weeks program of Physical Activity constructed by users during a design-based innovative workshops before the beginning of the interventions .
Receives: Behavioral: University-based intervention to promote PA and reduce ST
Control GroupNo interventionControl group: No intervention, only two measurement times

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline and post-intervention (8-week)

  2. 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.

    Measured: Baseline and post-intervention (8-week)

Secondary outcomes (10)

  1. 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 (%).

    Measured: Baseline and post-intervention (8-week)

  2. 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 (%).

    Measured: Baseline and post-intervention (8-week)

  3. 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 (%).

    Measured: Baseline and post-intervention (8-week)

  4. 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.

    Measured: Baseline and post-intervention (8-week)

  5. 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.

    Measured: Baseline and post-intervention (8-week)

  6. 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)

    Measured: Baseline and post-intervention (8-week)

  7. Changes in Physical Fitness: flexibility

    Participants complete a sit-and-reach test for flexibility

    Measured: Baseline and post-intervention (8-week)

  8. 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.

    Measured: Baseline and post-intervention (8-week)

  9. Changes in Physical Fitness: strength lower limb.

    Participants complete a muscular lower limb strength test measured with the dynamometric chair LegControl V2.

    Measured: Baseline and post-intervention (8-week)

  10. 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.

    Measured: Baseline and post-intervention (8-week)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Aug 2021
  2. Study start6 Sep 2021
  3. Primary completion17 Dec 2021
  4. Study completion17 Dec 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
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)
Enrolment
110 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05019482
Sponsor's protocol ID
UNimes.2
Status last verified
Jun 2022
First submitted
22 Jul 2021
Last updated
29 Jun 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Charbonnier E, Tremoliere B, Baussard L, Goncalves A, Lespiau F, Philippe AG, Le Vigouroux S. Effects of an online self-help intervention on university students' mental health during COVID-19: A non-randomized controlled pilot study. Comput Hum Behav Rep. 2022 Mar;5:100175. doi: 10.1016/j.chbr.2022.100175. Epub 2022 Feb 10.

    PubMed 35169655

  • 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

  • Ait-Aoudia M, Levy PP, Bui E, Insana S, de Fouchier C, Germain A, Jehel L. Validation of the French version of the Pittsburgh Sleep Quality Index Addendum for posttraumatic stress disorder. Eur J Psychotraumatol. 2013 Sep 12;4. doi: 10.3402/ejpt.v4i0.19298. eCollection 2013.

    PubMed 24044071

  • Boiche J, Gourlan M, Trouilloud D, Sarrazin P. Development and validation of the 'Echelle de Motivation envers l'Activite Physique en contexte de Sante': A motivation scale towards health-oriented physical activity in French. J Health Psychol. 2019 Mar;24(3):386-396. doi: 10.1177/1359105316676626. Epub 2016 Nov 21.

    PubMed 27872385

  • Lepine JP, Godchau M, Brun P. Anxiety and depression in inpatients. Lancet. 1985 Dec 21-28;2(8469-70):1425-6. doi: 10.1016/s0140-6736(85)92589-9. No abstract available.

    PubMed 2867417

  • Castro O, Bennie J, Vergeer I, Bosselut G, Biddle SJH. Correlates of sedentary behaviour in university students: A systematic review. Prev Med. 2018 Nov;116:194-202. doi: 10.1016/j.ypmed.2018.09.016. Epub 2018 Sep 25.

    PubMed 30266213

  • 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.

    PubMed 31975312

  • Deliens T, Van Crombruggen R, Verbruggen S, De Bourdeaudhuij I, Deforche B, Clarys P. Dietary interventions among university students: A systematic review. Appetite. 2016 Oct 1;105:14-26. doi: 10.1016/j.appet.2016.05.003. Epub 2016 May 13.

    PubMed 27181201

  • Galle F, Sabella EA, Ferracuti S, De Giglio O, Caggiano G, Protano C, Valeriani F, Parisi EA, Valerio G, Liguori G, Montagna MT, Romano Spica V, Da Molin G, Orsi GB, Napoli C. Sedentary Behaviors and Physical Activity of Italian Undergraduate Students during Lockdown at the Time of CoViD-19 Pandemic. Int J Environ Res Public Health. 2020 Aug 25;17(17):6171. doi: 10.3390/ijerph17176171.

    PubMed 32854414

  • Huckins JF, daSilva AW, Wang W, Hedlund E, Rogers C, Nepal SK, Wu J, Obuchi M, Murphy EI, Meyer ML, Wagner DD, Holtzheimer PE, Campbell AT. Mental Health and Behavior of College Students During the Early Phases of the COVID-19 Pandemic: Longitudinal Smartphone and Ecological Momentary Assessment Study. J Med Internet Res. 2020 Jun 17;22(6):e20185. doi: 10.2196/20185.

    PubMed 32519963

  • Kertechian S, Swami V. An examination of the factor structure and sex invariance of a French translation of the Body Appreciation Scale-2 in university students. Body Image. 2017 Jun;21:26-29. doi: 10.1016/j.bodyim.2017.02.005. Epub 2017 Mar 6.

    PubMed 28260632

  • Rodriguez-Larrad A, Manas A, Labayen I, Gonzalez-Gross M, Espin A, Aznar S, Serrano-Sanchez JA, Vera-Garcia FJ, Gonzalez-Lamuno D, Ara I, Carrasco-Paez L, Castro-Pinero J, Gomez-Cabrera MC, Marquez S, Tur JA, Gusi N, Benito PJ, Moliner-Urdiales D, Ruiz JR, Ortega FB, Jimenez-Pavon D, Casajus JA, Irazusta J. Impact of COVID-19 Confinement on Physical Activity and Sedentary Behaviour in Spanish University Students: Role of Gender. Int J Environ Res Public Health. 2021 Jan 6;18(2):369. doi: 10.3390/ijerph18020369.

    PubMed 33418907

  • Caron J. [A validation of the Social Provisions Scale: the SPS-10 items]. Sante Ment Que. 2013 Spring;38(1):297-318. doi: 10.7202/1019198ar. French.

    PubMed 24337002

  • Lee PH, Macfarlane DJ, Lam TH, Stewart SM. Validity of the International Physical Activity Questionnaire Short Form (IPAQ-SF): a systematic review. Int J Behav Nutr Phys Act. 2011 Oct 21;8:115. doi: 10.1186/1479-5868-8-115.

    PubMed 22018588

  • Smets EM, Garssen B, Bonke B, De Haes JC. The Multidimensional Fatigue Inventory (MFI) psychometric qualities of an instrument to assess fatigue. J Psychosom Res. 1995 Apr;39(3):315-25. doi: 10.1016/0022-3999(94)00125-o.

    PubMed 7636775

Questions about this trial

What is this clinical trial studying?

A study testing University-based intervention to promote PA and reduce ST in people with Physical Activity and Sedentary Behavior, run by University of Nimes at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in level of physical activity (PA) (time frame: Baseline and post-intervention (8-week)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05019482, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2022.

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