NCT05019482

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 22, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 24, 2021

Completed
13 days until next milestone

Study Start

First participant enrolled

September 6, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 17, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 17, 2021

Completed
Last Updated

June 29, 2022

Status Verified

June 1, 2022

Enrollment Period

3 months

First QC Date

July 22, 2021

Last Update Submit

June 24, 2022

Conditions

Keywords

Physical ActivitySedentary Behaviorstudent

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (10)

  • Change in body fat

    Baseline and post-intervention (8-week)

  • Change in body muscle

    Baseline and post-intervention (8-week)

  • Change in body water

    Baseline and post-intervention (8-week)

  • Change in visceral fat rating

    Baseline and post-intervention (8-week)

  • Body Mass Index (BMI)

    Baseline and post-intervention (8-week)

  • +5 more secondary outcomes

Other Outcomes (12)

  • Changes in Physical Activity as measured by the International Physical Activity - Short Form (IPAQ-SF)

    Baseline and post-intervention (8-week)

  • Changes in motivation

    Baseline and post-intervention (8-week)

  • Changes in sleep quality (PSQI)

    Baseline and post-intervention (8-week)

  • +9 more other outcomes

Study Arms (2)

University-based 8-weeks intervention to promote Physical Activity (PA)

EXPERIMENTAL

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

Control Group

NO INTERVENTION

Control group: No intervention, only two measurement times

Interventions

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

University-based 8-weeks intervention to promote Physical Activity (PA)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Students at the University of Nimes

You may not qualify if:

  • Physical diseases that prevent PA practice
  • not to be a student of the University of Nîmes
  • not signing the consent form to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universite de Nimes

Nîmes, 30021, France

Location

Related Publications (17)

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    PMID: 35169655BACKGROUND
  • 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

    BACKGROUND
  • 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.

    PMID: 24044071BACKGROUND
  • 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.

    PMID: 27872385BACKGROUND
  • 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.

    PMID: 2867417BACKGROUND
  • 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.

    PMID: 30266213BACKGROUND
  • 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.

    PMID: 31975312BACKGROUND
  • 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.

    PMID: 27181201BACKGROUND
  • 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.

    PMID: 32854414BACKGROUND
  • 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.

    PMID: 32519963BACKGROUND
  • 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.

    PMID: 28260632BACKGROUND
  • 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.

    PMID: 33418907BACKGROUND
  • 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.

    PMID: 24337002BACKGROUND
  • 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.

    PMID: 22018588BACKGROUND
  • 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.

    PMID: 7636775BACKGROUND
  • Le Vigouroux S, Goncalves A, Charbonnier E. The Psychological Vulnerability of French University Students to the COVID-19 Confinement. Health Educ Behav. 2021 Apr;48(2):123-131. doi: 10.1177/1090198120987128. Epub 2021 Jan 20.

  • Goncalves A, Bernal C, Korchi K, Nogrette M, Deshayes M, Philippe AG, Gisclard B, Charbonnier E. Promoting Physical Activity Among University Students During the COVID-19 Pandemic: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2022 Jun 13;11(6):e36429. doi: 10.2196/36429.

MeSH Terms

Conditions

Motor ActivitySedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • ELODIE CHARBONNIER, PhD

    UNIVERSITE DE NIMES - UPR APSY-v

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

July 22, 2021

First Posted

August 24, 2021

Study Start

September 6, 2021

Primary Completion

December 17, 2021

Study Completion

December 17, 2021

Last Updated

June 29, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations