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

April 25, 2023 updated by: University Hospital, Clermont-Ferrand

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France
        • Chu Clermont-Ferrand

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Establishment of physical activity sessions for pregnant women
All the women will receive the studied 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Establishing Adherence of PA sessions during pregnancy
Time Frame: through study completion, an average of 1 year
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
Time Frame: through study completion, an average of 1 year
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
Time Frame: day1
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
Time Frame: day 70
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
Time Frame: day 133
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pregnant women's PA level and sedentary behavior
Time Frame: before the first PA session, at the end of the sixth month of gestation, and at the end of all the sessions (9 months)
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)
Changes in these pregnant women's quality of life
Time Frame: Before the first PA session, at 6 months of gestation, and at the end of all the sessions (9 months)
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)
The facilitators of and obstacles to the sessions' acceptability will be assessed in semi-directive interviews conducted by a midwife.
Time Frame: at the end of all the sessions (9 months)
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)
Willingness to pay
Time Frame: at the end of all the sessions (9 months)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 28, 2022

Primary Completion (Actual)

February 27, 2023

Study Completion (Actual)

February 27, 2023

Study Registration Dates

First Submitted

January 12, 2022

First Submitted That Met QC Criteria

January 26, 2022

First Posted (Actual)

February 4, 2022

Study Record Updates

Last Update Posted (Actual)

April 26, 2023

Last Update Submitted That Met QC Criteria

April 25, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RBHP 2021 VENDITTELLI
  • 2021-A01683-38 (Other Identifier: 2021-A01683-38)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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