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Sedentary BehaviorPregMouvNCT05225376

Physical Activity and Sedentary Lifestyle During Pregnancy: Feasibility and Impact Study on Sedentary Behavior

A study testing Physical activity sessions for pregnant women in people with Sedentary Behavior and Pregnancy Related, run by University Hospital, Clermont-Ferrand 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

Background: Physical activity (PA) has beneficial effects on health, physical condition, and the maintenance of autonomy and independence at all ages of life. It also has numerous benefits during pregnancy: maintenance or improvement of physical condition, prevention of excessive weight gain, aid in postpartum weight… Read more about this study

Who is it for?
Ages 19 to 50 years, women only
What is being tested?
Physical activity sessions for pregnant women
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteFrance
Study dates
28 Apr 2022to 27 Feb 2023
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 19 to 50 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Adult pregnant women receiving prenatal care at the Estaing UHC maternity ward,
  • Seen for prenatal care before the 21st week of gestation and booked to give birth at the Estaing UHC
  • Agreeing to follow the full PA program proposed,
  • Able to provide informed consent to participate in research,
  • And covered by the national health insurance fund (or an affiliate).

Who cannot join

  • Multiple pregnancy,
  • With a relative or absolute contraindication to performing PA physical activity (see Tables 1 and 2, extracted from the French national authority for health guidelines for physical activity during pregnancy),
  • Under guardianship or conservatorship,
  • Or refusing to participate in the study.

Trial locations and contacts

1 site in 1 country.

France1 site

  • CHU clermont-ferrand

    Clermont-Ferrand

Other trials in France

About this study

Background:

Physical activity (PA) has beneficial effects on health, physical condition, and the maintenance of autonomy and independence at all ages of life. It also has numerous benefits during pregnancy: maintenance or improvement of physical condition, prevention of excessive weight gain, aid in postpartum weight loss, prevention of gestational hypertension, reduction in number of macrosomic infants at birth, reduction in lower back and pelvic pain, and prevention and improvement of postpartum depressive symptoms. A recent systematic review of the literature concluded that interventions to increase PA levels among pregnant women have a positive effect on this level. The studies included in the review also showed that these interventions have a positive effect on these women's well-being and their mental and physical health. Nonetheless, no study has examined this subject in France. Moreover, to our knowledge, no study in the international literature has looked at online interactive video sessions of PA during pregnancy.

Read more

Overall, few studies allow an assessment of the effect of sedentary behavior and inadequate PA during pregnancy on maternal, neonatal, or infant outcomes. This is equally true for the health of adults whose mothers were physically active during pregnancy. Moreover, we do not know the actual level of PA of women in France. Finally, we do not know what types of intervention described in the literature would enable the best adherence by French women to their initiation or maintenance of an adequate PA level.

Study hypothesis:

Our hypothesis is that setting up a free program of physical and sports activity session for pregnant women will enable them to meet the guidelines for PA practice during this period and to reduce their sedentary behavior.

Objectives:

1.1. Principal objective To study the feasibility of setting up physical activity (PA) sessions for pregnant women during their prenatal care, by assessing its acceptability, the perceived difficulty of the sessions, and their satisfaction with these sessions.

1.2. Secondary objectives

  • To evaluate the effect of these sessions:
  • on the PA level and sedentary behavior of pregnant women,
  • on their quality of life (QoL).
  • The feasibility and impact of the sessions will be studied according to their PA level at inclusion: active or inactive.
  • To identify the facilitators of and obstacles to the acceptability of these sessions, other than those studied in the objectives above.
  • To measure the willingness to pay of pregnant women so that we can quantify how much they would be willing to pay for such a program, were it were not free. Willingness to pay (measured in €) makes it possible to measure indirectly the acceptability of the program to the participants and the monetary value they attribute to it.
Read the detailed description

Type of study:

Prospective interventional cohort feasibility study of PA sessions for pregnant women.

Number of centers: 1

One center: the Clermont-Ferrand university hospital center

Study description:

The study is based on voluntary participation in organized sessions of PA. For each woman the program will comprise 51 sessions (for a woman giving birth after 39 weeks of gestation) with three sessions a week starting between 21+6 d and 23+6 d weeks through 39+0 d weeks. Women will be asked to attend all three sessions each week. Each session will include a maximum of 5 women and will last for 45 minutes, with 30 minutes of endurance (aerobic) PA, as well as muscle (strength) training and some stretching. They will also include advice to women to limit their sedentary time and to allow them to perform PA outside of these sessions with an instructor. In addition to the mandatory weekly session in person, two sessions will be proposed as interactive video classes. A Zoom® link will be offered to the women so that they can connect to these two weekly sessions, taught by the adapted PA (APA) professional who teaches the in-person sessions. These sessions will have the same format as the in-person session (45 minutes) with viewing of both the APA professional (trainer/coach) and the participants (who can choose to be masked). The APA professional will also see the participants and thus can at any time correct their positions and give them individualized advice.

Study plan and procedures:

The women will be informed about the study from their first trimester of pregnancy. If they want to participate in the study and the PA sessions, they must contact the research midwife. Before their first participation in a PA session, each woman will meet with the research midwife, who will review with her the information about the study, verify the eligibility criteria, and obtain her written informed consent. During the first session, the woman will perform two physical ability tests (described below) with the APA instructor, to determine her initial PA level and her physical capacities.

At the end of each session, the instructor will record the women present or connected and evaluate the perceived difficulty of the session by having the women complete in their notebooks the Borg rating of perceived exertion, the scale of intensity according to the affective valence, and the conversation test.

At the end of the sixth month of gestation (28 weeks), the women will retake these physical ability tests with the instructor, complete the self-administered acceptability questionnaires and the PPAQ on line or in person. At the end of the eighth month of gestation (37 weeks), the women will retake these physical ability tests with the instructor, complete the self-administered acceptability questionnaires, and the PPAQ, on line or in person. At the end of their personnal program, the women will complete on line or in person the self-administered acceptability and satisfaction questionnaires and the WHOQOL-Brief. A short semi-directive telephone interview will then be performed to identify the facilitators of and obstacles to acceptability.

Being tested
Physical activity sessions for pregnant women
Keywords
pregancy, exercice, sedentary, maternal morbidity
Medical subject headings
Sedentary Behavior

What participants receive

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

  • Physical activity sessions for pregnant womenOther

    The physical activity sessions will take place once a week at the Estaing UHC, in the room used for the childbirth and parenting preparation classes of the outpatient obstetrics-gynecology clinic; and twice a week on Zoom. These sessions will be supervised by an APA professional (degree in STAPS and APA).

    The measurement of the women's physical conditions will make it possible to adapt and individualize the PA sessions to each woman's level.

Study groups in NCT05225376
Study groupRoleWhat they receive
Establishment of physical activity sessions for pregnant womenExperimentalAll the women will receive the studied intervention
Receives: Other: Physical activity sessions for pregnant women

What is being measured

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

  1. Establishing Adherence of PA sessions during pregnancy

    Women's adherence to the sessions proposed (% who attend all sessions until delivery).

    Measured: through study completion, an average of 1 year

  2. Establishing perceived difficulty of PA sessions during pregnancy

    The perceived difficulty of the sessions will be evaluated by the women themselves with a self-administered questionnaire.

    Measured: through study completion, an average of 1 year

  3. Establishing women's satisfaction of PA sessions during pregnancy

    Satisfaction with the PA sessions for pregnant women during their prenatal care will be based on a self-administered questionnaire. Women's overall satisfaction with the sessions will be assessed on a numeric scale ranging from 0 to 10.

    Measured: day1

  4. Establishing women's satisfaction of PA sessions during pregnancy

    Satisfaction with the PA sessions for pregnant women during their prenatal care will be based on a self-administered questionnaire. Women's overall satisfaction with the sessions will be assessed on a numeric scale ranging from 0 to 10.

    Measured: day 70

  5. Establishing women's satisfaction of PA sessions during pregnancy

    Satisfaction with the PA sessions for pregnant women during their prenatal care will be based on a self-administered questionnaire. Women's overall satisfaction with the sessions will be assessed on a numeric scale ranging from 0 to 10.

    Measured: day 133

Secondary outcomes (4)

  1. Pregnant women's PA level and sedentary behavior

    These will be assessed with the French version of the PPAQ (Pregnancy Physical Activity Questionnaire) questionnaire. Their physical condition will also be assessed by physical ability tests (Cardiopulmonary endurance (6-minute walk test); Handgrip test with dynamometer) , all conducted by the APA instructors.

    Measured: before the first PA session, at the end of the sixth month of gestation, and at the end of all the sessions (9 months)

  2. Changes in these pregnant women's quality of life

    The pregnant women's QoL will be assessed with the self-administered WHOQOL-Brief questionnaire, which has been validated in French. It was chosen because it specifically evaluates comprehensive/overall QoL over the past 2 weeks. It is a generic, multidimensional questionnaire. It explores 6 dimensions (physical health, psychological well-being, satisfaction with life, social relationships, environment, and spirituality). A score is calculated from each item. A user manual is available, free of charge, from the WHO web site.

    Measured: Before the first PA session, at 6 months of gestation, and at the end of all the sessions (9 months)

  3. The facilitators of and obstacles to the sessions' acceptability will be assessed in semi-directive interviews conducted by a midwife.

    These interviews, based on a semi-directive interview guide, will focus on the following themes: (1) the perceived importance of PA during pregnancy; (2) the level of understanding and appropriation of the support procedures provided during the pregnancy; (3) satisfaction with the workshops proposed and their relation with daily QoL; (4) suggestions for improvement to better meet women's expectations. The estimated duration of these interviews is from 30 to 45 minutes.

    Measured: at the end of all the sessions (9 months)

  4. Willingness to pay

    This will be collected during the interview. The pregnant women will be asked how much they would be willing to pay to participate in such a program, outside of the study. If the willingness to pay is low, the interviewer can then organize the discussion around the financial obstacles: nonreimbursement by health insurance, economic situation, and nonadherence.

    Measured: at the end of all the sessions (9 months)

Timeline

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

  1. First posted4 Feb 2022
  2. Study start28 Apr 2022
  3. Primary completion27 Feb 2023
  4. Study completion27 Feb 2023

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
Not applicable
Intervention model
Single group
Model description
all participants will receive the same intervention
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05225376
Sponsor's protocol ID
RBHP 2021 VENDITTELLI
Other IDs
2021-A01683-38
Acronym
PregMouv
Status last verified
Apr 2023
First submitted
12 Jan 2022
Last updated
26 Apr 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Haute Autorité de Santé. Guide de promotion, consultation et prescription médicale d'activité physique et sportive pour la santé chez les adultes [Internet]. 2019. Disponible sur: https://www.has-sante.fr/upload/docs/application/pdf/2018-10/guide_aps_vf.pdf

  • Institut national de la santé et de la recherche médicale (France). Activité physique: prévention et traitement des maladies chroniques. 2019.

  • Organisation mondiale de la santé. Recommandations mondiales sur l'activité physique pour la santé. Genève: OMS; 2010.

  • Haute Autorité de Santé. Prescription d'activité physique et sportive Pendant la grossesse et en post-partum [Internet]. Saint-Denis: HAS; [cité 2 mars 2020] p. 14. Disponible sur: https://www.has-sante.fr/upload/docs/application/pdf/2019-07/app_329_ref_aps_grossesse_vf.pdf

  • Agence nationale de sécurité sanitaire, de l'alimentation, de l'environnement, et du travail. Actualisation des repères du PNNS - Révisions des repères relatifs à l'activité physique et à la sédentarité [Internet]. Maison-Alfort; 2016 [cité 15 juill 2020]. Disponible sur: https://www.anses.fr/fr/system/files/NUT2012SA0155Ra.pdf

  • Verdot C, Salanave B, Deschamps V. Activité physique et sédentarité dans la population française. Situation en 2014- 2016 et évolution depuis 2006-2007. Bull Epidémiol Hebd. 2020;15:296-304.

  • Équipe de surveillance et d'épidémiologie nutritionnelle (Esen). Étude de santé sur l'environnement, la biosurveillance, l'activité physique et la nutrition (Esteban), 2014-2016. Volet Nutrition. Chapitre Activité physique et sédentarité. 2e édition [Internet]. Saint-Maurice: Santé publique France; 2020 p. 58. Disponible sur: www.santepubliquefrance.fr

  • DIVISION OF MENTAL HEALTH AND PREVENTION OF SUBSTANCE ABUSE WORLD HEALTH ORGANIZATION. WHOQOL User Manual [Internet]. WHO; 2012 [cité 21 oct 2020] p. 106. Disponible sur: https://apps.who.int/iris/bitstream/handle/10665/77932/WHO_HIS_HSI_Rev.2012.03_eng.pdf?sequence=1&isAllowed=y

  • Inserm (dir.). Activité physique : contextes et effets sur la santé. Rapport. [Internet]. Les éditions Inserm. Paris; 2008 [cité 23 juill 2020]. 811 p. Disponible sur: http://www.ipubli.inserm.fr/bitstream/handle/10608/97/expcol_2008_activite.pdf?sequence=1

  • Ekelund U, Tarp J, Steene-Johannessen J, Hansen BH, Jefferis B, Fagerland MW, Whincup P, Diaz KM, Hooker SP, Chernofsky A, Larson MG, Spartano N, Vasan RS, Dohrn IM, Hagstromer M, Edwardson C, Yates T, Shiroma E, Anderssen SA, Lee IM. Dose-response associations between accelerometry measured physical activity and sedentary time and all cause mortality: systematic review and harmonised meta-analysis. BMJ. 2019 Aug 21;366:l4570. doi: 10.1136/bmj.l4570.

    PubMed 31434697

  • Fazzi C, Saunders DH, Linton K, Norman JE, Reynolds RM. Sedentary behaviours during pregnancy: a systematic review. Int J Behav Nutr Phys Act. 2017 Mar 16;14(1):32. doi: 10.1186/s12966-017-0485-z.

    PubMed 28298219

  • Brekke I, Richardsen KR, Jenum AK. Sickness absence in pregnancy and sedentary behavior: a population-based cohort study from Norway. BMC Public Health. 2019 Jan 16;19(1):71. doi: 10.1186/s12889-018-6379-4.

    PubMed 30651106

  • Barone Gibbs B, Paley JL, Jones MA, Whitaker KM, Connolly CP, Catov JM. Validity of self-reported and objectively measured sedentary behavior in pregnancy. BMC Pregnancy Childbirth. 2020 Feb 11;20(1):99. doi: 10.1186/s12884-020-2771-z.

    PubMed 32046663

  • van der Waerden J, Nakamura A, Pryor L, Charles MA, El-Khoury F, Dargent-Molina P; EDEN Mother-Child Cohort Study Group. Domain-specific physical activity and sedentary behavior during pregnancy and postpartum depression risk in the French EDEN and ELFE cohorts. Prev Med. 2019 Apr;121:33-39. doi: 10.1016/j.ypmed.2019.02.012. Epub 2019 Feb 11.

    PubMed 30763624

  • Poudevigne MS, O'Connor PJ. A review of physical activity patterns in pregnant women and their relationship to psychological health. Sports Med. 2006;36(1):19-38. doi: 10.2165/00007256-200636010-00003.

    PubMed 16445309

Questions about this trial

What is this clinical trial studying?

A study testing Physical activity sessions for pregnant women in people with Sedentary Behavior and Pregnancy Related, run by University Hospital, Clermont-Ferrand 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 5 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 26 Apr 2023. 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?

Establishing Adherence of PA sessions during pregnancy (time frame: through study completion, an average of 1 year). The study lists 5 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 NCT05225376, which also lists 22 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 26 Apr 2023.

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