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

NCT05225376 | Completed

• 2 other identifiers: RBHP 2021 VENDITTELLI2021-A01683-38
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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 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. 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.

Conditions

Sedentary Behavior; Pregnancy Related; Perinatal Problems; Sedentary Time; Morbidity;Perinatal

Keywords

pregancy; exercice; sedentary; maternal morbidity

Outcome Measures

Primary Outcomes (5)

• Establishing Adherence of PA sessions during pregnancy

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

  through study completion, an average of 1 year

• 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.

  through study completion, an average of 1 year

• 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.

  day1

• 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.

  day 70

• 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.

  day 133

Secondary Outcomes (4)

• Pregnant women's PA level and sedentary behavior

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

• Changes in these pregnant women's quality of life

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

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

  at the end of all the sessions (9 months)

• Willingness to pay

  at the end of all the sessions (9 months)

Study Arms (1)

Establishment of physical activity sessions for pregnant women

EXPERIMENTAL

All the women will receive the studied intervention

Other: Physical activity sessions for pregnant women

Interventions

Physical activity sessions for pregnant women OTHER

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.

Establishment of physical activity sessions for pregnant women

Eligibility Criteria

• Age: 19 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU clermont-ferrand

Clermont-Ferrand, France

Location

Related Publications (22)

• 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

  BACKGROUND

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

  BACKGROUND

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

  BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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.

  BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 31434697 RESULT

• 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.

  PMID: 28298219 RESULT

• 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.

  PMID: 30651106 RESULT

• 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.

  PMID: 32046663 RESULT

• 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.

  PMID: 30763624 RESULT

• 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.

  PMID: 16445309 RESULT

• Chan CWH, Au Yeung E, Law BMH. Effectiveness of Physical Activity Interventions on Pregnancy-Related Outcomes among Pregnant Women: A Systematic Review. Int J Environ Res Public Health. 2019 May 23;16(10):1840. doi: 10.3390/ijerph16101840.

  PMID: 31126153 RESULT

• Sekhon M, Cartwright M, Francis JJ. Acceptability of healthcare interventions: an overview of reviews and development of a theoretical framework. BMC Health Serv Res. 2017 Jan 26;17(1):88. doi: 10.1186/s12913-017-2031-8.

  PMID: 28126032 RESULT

• Teychenne M, Abbott G, Stephens LD, Opie RS, Olander EK, Brennan L, van der Pligt P, Apostolopoulos M, Ball K. Mums on the Move: A pilot randomised controlled trial of a home-based physical activity intervention for mothers at risk of postnatal depression. Midwifery. 2021 Feb;93:102898. doi: 10.1016/j.midw.2020.102898. Epub 2020 Nov 27.

  PMID: 33290891 RESULT

• Chandonnet N, Saey D, Almeras N, Marc I. French Pregnancy Physical Activity Questionnaire compared with an accelerometer cut point to classify physical activity among pregnant obese women. PLoS One. 2012;7(6):e38818. doi: 10.1371/journal.pone.0038818. Epub 2012 Jun 11.

  PMID: 22701717 RESULT

• ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available.

  PMID: 12091180 RESULT

• Arcuri JF, Borghi-Silva A, Labadessa IG, Sentanin AC, Candolo C, Pires Di Lorenzo VA. Validity and Reliability of the 6-Minute Step Test in Healthy Individuals: A Cross-sectional Study. Clin J Sport Med. 2016 Jan;26(1):69-75. doi: 10.1097/JSM.0000000000000190.

  PMID: 25706661 RESULT

• Baumann C, Erpelding ML, Regat S, Collin JF, Briancon S. The WHOQOL-BREF questionnaire: French adult population norms for the physical health, psychological health and social relationship dimensions. Rev Epidemiol Sante Publique. 2010 Feb;58(1):33-9. doi: 10.1016/j.respe.2009.10.009. Epub 2010 Jan 21.

  PMID: 20096515 RESULT

MeSH Terms

Conditions

Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Françoise Vendittelli

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: all participants will receive the same intervention

Study Record Dates

• First Submitted: January 12, 2022
• First Posted: February 4, 2022
• Study Start: April 28, 2022
• Primary Completion: February 27, 2023
• Study Completion: February 27, 2023
• Last Updated: April 26, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)