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

Pregnancy Related Clinical Trial

— PregMouv  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05225376
• Other study ID #: RBHP 2021 VENDITTELLI
• Secondary ID: 2021-A01683-38
• Status: Completed
• Phase: N/A
• Start date: April 28, 2022
• Est. completion date: February 27, 2023

Study information

• Verified date: April 2023
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: February 27, 2023
• Est. primary completion date: February 27, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years to 50 Years

Eligibility

Inclusion Criteria:

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).

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

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

Intervention

Other:
• Physical activity sessions for pregnant women
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.

Locations

Country	Name	City	State
France	CHU clermont-ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

References & Publications (22)

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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: — View Citation

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. — View Citation

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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. Epu — View Citation

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

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 associ — View Citation

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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. — View Citation

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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

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

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.

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. — View Citation

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. — View Citation

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 — View Citation

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 c — View Citation

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* Note: There are 22 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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.	before the first PA session, at the end of the sixth month of gestation, and at the end of all the sessions (9 months)
Secondary	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.	Before the first PA session, at 6 months of gestation, and at the end of all the sessions (9 months)
Secondary	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.	at the end of all the sessions (9 months)
Secondary	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.	at the end of all the sessions (9 months)