Clinical trial NCT05225376: Physical Activity and Sedentary Lifestyle During Pregnancy: Feasibility and Impact Study on Sedentary Behavior
Official title: Physical Activity and Sedentary Lifestyle During Pregnancy: Feasibility and Impact Study on Sedentary Behavior
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sedentary Behavior
Pregnancy Related
Perinatal Problems
Sedentary Time
Morbidity;Perinatal
Keywords: pregancy
exercice
sedentary
maternal morbidity
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2022-02-04
Enrollment: 25
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: all participants will receive the same intervention
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Establishing Adherence of PA sessions during pregnancy
timeFrame: through study completion, an average of 1 year
measure: Establishing perceived difficulty of PA sessions during pregnancy
timeFrame: through study completion, an average of 1 year
measure: Establishing women's satisfaction of PA sessions during pregnancy
timeFrame: day1
measure: Establishing women's satisfaction of PA sessions during pregnancy
timeFrame: day 70
measure: Establishing women's satisfaction of PA sessions during pregnancy
timeFrame: day 133
Secondary outcomes:
measure: Pregnant women's PA level and sedentary behavior
timeFrame: before the first PA session, at the end of the sixth month of gestation, and at the end of all the sessions (9 months)
measure: Changes in these pregnant women's quality of life
timeFrame: Before the first PA session, at 6 months of gestation, and at the end of all the sessions (9 months)
measure: The facilitators of and obstacles to the sessions' acceptability will be assessed in semi-directive interviews conducted by a midwife.
timeFrame: at the end of all the sessions (9 months)
measure: Willingness to pay
timeFrame: at the end of all the sessions (9 months)
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU clermont-ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Françoise Vendittelli
role: PRINCIPAL_INVESTIGATOR
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