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

NCT ID: NCT05019482

Last Updated: 2022-06-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-06

Study Completion Date

2021-12-17

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Physical Activity Sedentary Behavior Young Adults Student

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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 .

Group Type EXPERIMENTAL

University-based intervention to promote PA and reduce ST

Intervention Type BEHAVIORAL

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

Control Group

Control group: No intervention, only two measurement times

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Nimes

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

aurelie goncalves

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

ELODIE CHARBONNIER, PhD

Role: STUDY_DIRECTOR

UNIVERSITE DE NIMES - UPR APSY-v

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Universite de Nimes

Nîmes, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 35169655 (View on PubMed)

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

Reference Type 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.

Reference Type BACKGROUND
PMID: 24044071 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27872385 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2867417 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30266213 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31975312 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27181201 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32854414 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32519963 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28260632 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33418907 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24337002 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22018588 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7636775 (View on PubMed)

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.

Reference Type RESULT
PMID: 33472453 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35700019 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

UNimes.2

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Web-based Physical Activity Program
NCT01218412 UNKNOWN PHASE1