Physical Activity and Sedentary Behavior During Pregnancy (PREGMOUV)

University Hospital, Clermont-Ferrand

Status: Enrolling

Conditions: Pregnant Woman

Treatments: Behavioral: In person and by videoconference (mixed format) PA sessions.; Behavioral: In person PA sessions; Behavioral: Interactive videoconference PA sessions

Study type: Interventional

Funder types: Other

Identifiers

NCT06585085

RBHP 2024 BARASINSKI

2024-A00459-38 (Other Identifier)

Details and patient eligibility

About

Our main objective is to evaluate the intervention that best enables women's adherence to physical activity (PA).

Our hypothesis is that identifying types of interventions suitable for pregnant women (in-person PA sessions, videoconferences or mixed format) could help improve their PA level and simultaneously reduce their sedentary behavior (SB).

Full description

PA has beneficial effects on physical, psychological, and social health, and its regular practice helps to prevent numerous chronic diseases. During pregnancy, PA also has many benefits for women's physical condition, weight gain, gestational hypertension, lower back and pelvic pain, and postpartum depressive symptoms and may also reduce fetal macrosomia and positively affect neurogenesis, language development, memory, and other learning-associated cognitive functions. (CNSF 2021). PA is thus recommended to all pregnant women for 150 to 180 minutes a week, adapted to their health status, physical condition, and course of pregnancy. It is also recommended that women limit their Sedentary Behaviour (SB) (to ≤7 waking h/day) during pregnancy.

No French study has assessed the impact of a PA program during pregnancy, and no published study has proposed videoconference PA sessions during pregnancy. Pregnant women's adherence to PA is a limiting factor found in many interventional studies. Possible changes in maternal behavior in practicing PA and reducing SB during pregnancy could also favorably affect the health of mother and child and thus subsequent PA. Given PA's many benefits and SB's harmful effects during pregnancy, assessing programs that enable pregnant women to both increase PA levels and reduce SB seems pertinent and valuable.

Enrollment: 630 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Pregnant women of more of 18 years and who are being monitored for pregnancy in the Clermont-Ferrand metropolitan area,
• Planned to give birth in a maternity unit localized in Clermont-Ferrand metropolitan area (CHU Estaing or Clinique de la Chataigneraie),
• Agreeing to be randomized, to follow the physical activity program offered in the Clermont-Ferrand metropolitan area, and to follow up as part of the study,
• Able to give informed consent to participate in the research,
• Affiliated to a social security scheme
• And between 14+0d and 21+6d weeks of gestation.

Non inclusion Criteria:

• Women under guardianship, curators, deprived of liberty or under court protection,
• With a history of recurrent miscarriage,
• Presenting a multiple pregnancy,
• Hemoglobinemia <9g/dL or symptomatic anemia,
• Presenting eating disorders or a BMI ≤ 18.5 or a BMI ≥ 40,
• With orthopedic limitations,
• Presenting cardiovascular or pulmonary disease,
• Uncontrolled thyroid disease,
• Presenting a high level of smoking,
• With significant health problems,
• Premature rupture of membranes,
• Premature labor during this pregnancy or a history of at least 2 premature births,
• Persistent vaginal bleeding,
• Cervical incompetence,
• Evidence of intrauterine growth restriction,
• Uncontrolled epilepsy,
• Diabetes (previous or gestational, diagnosed in the 1st trimester) or chronic hypertension,
• Or having a planned home birth.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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630 participants in 4 patient groups

A - Free PA practice

No Intervention group

Description:

The women in group A (control group) will receive the usual care provided for any pregnancy, i.e. personalised information on physical activity and sedentary behaviour, with the provision of information booklets. They will be free to exercise during their pregnancy

B

Experimental group

Description:

In-person supervised PA sessions

Treatment:

Behavioral: In person PA sessions

C

Experimental group

Description:

Interactive videoconference PA sessions

Treatment:

Behavioral: Interactive videoconference PA sessions

D

Experimental group

Description:

In person and by videoconference (mixed format) PA sessions

Treatment:

Behavioral: In person and by videoconference (mixed format) PA sessions.