Physical Activity and Sedentary Lifestyle During Pregnancy: Feasibility and Impact Study on Sedentary Behavior
Condition: Sedentary Behavior; Pregnancy Related; Perinatal Problems; Sedentary Time; Morbidity;Perinatal
Study type: Interventional

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.
    

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.
    

Intervention name(s): Physical activity sessions for pregnant women
Intervention type(s): Other
Intervention description(s): 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.
Intervention model: Single Group Assignment
Intervention model description: all participants will receive the same intervention
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: pregancy; exercice; sedentary; maternal morbidity