RecruitingNAINTERVENTIONAL

Physical Activity and Sedentary Behavior During Pregnancy

This study is exploring the most effective ways to encourage pregnant women to be more physically active and reduce the amount of time they spend sitting down. We’re comparing three different approaches: physical activity classes held in person, online sessions using video calls, or a combination of both in-person and online activities. The main goal is to find out which method best helps women stick to their physical activity goals during pregnancy. Being active is very important for both the mother's and baby's health, offering benefits like better fitness, healthy weight gain, and even reducing certain pregnancy discomforts. By identifying successful programmes, we hope to help more pregnant women enjoy these benefits and improve their wellbeing.

At a glance

Status

Recruiting

Phase

Sponsor

University Hospital, Clermont-Ferrand

Enrolment target

630

Start

10 Sep 2024

Estimated completion

01 Oct 2027

Pregnant Woman

What is this study about?

Being active has lots of great benefits for everyone, and it's especially good for pregnant women. Regular activity can help with your physical fitness, manage weight gain during pregnancy, reduce problems like high blood pressure, and ease back or pelvic pain. It might even help with mood after the baby is born. For the baby, being active could lead to a healthier birth weight and even help with brain development.

Because exercise is so important, health experts recommend that pregnant women aim for 150 to 180 minutes of activity each week, as long as it's right for their health and stage of pregnancy. They also suggest limiting sitting time to less than 7 hours a day. However, we know it can be tricky to keep up with exercise during pregnancy.

This study wants to find the best way to support pregnant women in being active. We're looking at different types of support – some women will have in-person exercise sessions, others will join online classes through video calls, and a third group will have a mix of both. By comparing these, we hope to discover which approach makes it easiest for women to stay active and sit less during pregnancy. This will help us create better programmes in the future to keep mothers and babies healthy.

Key takeaways

This study helps pregnant women be more active and sit less.
It compares in-person, online, or mixed exercise sessions.
Being active during pregnancy is good for both mum and baby.
The study aims to find the best way to support pregnant women's activity.
You must be between 14 and almost 22 weeks pregnant to join.
You have the right to withdraw from the study at any time.

Who may be eligible?

To join this study, you need to be pregnant, at least 18 years old, and receiving your pregnancy care in the Clermont-Ferrand area in France. You should be planning to give birth at Estaing Hospital or Clinique de la Chataigneraie. Your pregnancy also needs to be between 14 and nearly 22 weeks along (specifically, 14 weeks and 0 days, up to 21 weeks and 6 days).

There are some reasons why you might not be able to take part. For example, if you are under special legal care or in prison, or if you've had several miscarriages before. You also couldn't join if you're expecting more than one baby (e.g., twins), have very low iron levels or symptoms from a lack of iron, or have certain eating disorders or a very low or very high body mass index (BMI under 18.5 or over 40).

Other reasons for not being able to join include significant physical limitations (like serious bone or joint problems), heart or lung conditions, uncontrolled thyroid problems, high levels of smoking, or other major health issues. If you have had early labour in this pregnancy or two or more previous early births, persistent vaginal bleeding, a weakened cervix, signs of the baby not growing well, uncontrolled epilepsy, certain types of diabetes (like gestational diabetes diagnosed early on), or high blood pressure, you wouldn't be eligible. Lastly, if you are planning a home birth, you would also not be able to join the study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Are you between 14 weeks and 6 days pregnant and 21 weeks and 6 days pregnant?
Are you receiving pregnancy care and planning to give birth in the Clermont-Ferrand area in France?
Do you have no major health conditions (like serious heart issues, uncontrolled diabetes, or certain high-risk pregnancy complications)?
Are you not expecting multiple babies (like twins or triplets)?
Are you willing to be randomly assigned to an exercise group and participate in follow-up appointments?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be assigned to one of three groups by chance: either in-person physical activity sessions, online video physical activity sessions, or a mix of both. You will then follow the physical activity programme offered to your group. The study will involve regular check-ups to see how well the programme is working for you, including measuring your physical activity levels and how much time you spend sitting. The total duration of your involvement in the study will depend on how long the physical activity programme lasts and the follow-up assessments, but it will be throughout your pregnancy.

Potential risks and benefits

Taking part in this study could potentially offer you the benefit of increased physical activity and reduced sitting time, which experts agree has many positive effects on your health and your baby's health during pregnancy. The physical activity programmes are designed to be safe and suitable for pregnant women. As with any exercise programme, there's always a small risk of discomfort or minor injury, but the sessions will be adapted to your health and stage of pregnancy. You are always in control and can stop participating in the study at any time, for any reason, without it affecting your medical care.

Locations (1)

CHU de Clermont-Ferrand
Verified postcode
Clermont-Ferrand, France· Recruiting

Common questions

What kind of physical activities will I be doing?

The study aims to help you meet recommended activity levels, which could include walking, swimming, or other gentle exercises tailored for pregnancy. You'll be in a group doing either in-person, online, or mixed sessions.

Will I have to pay to join the study or for the activity sessions?

The study information doesn't mention any costs for participants. Typically, clinical trials cover the costs related to participation in the study interventions.

How much time will I need to commit to the study each week?

You'll be encouraged to aim for 150 to 180 minutes of activity per week, plus time for any check-ups or sessions as part of your study group. The exact time commitment for sessions will depend on your assigned group.

What happens if I start the study but then decide I don't want to continue?

You are free to leave the study at any time, for any reason. Your decision will not affect your medical care beyond the study.

Will the study results affect my medical care or my baby's health information?

Your individual medical care won't be changed by whether you're in the study or not. The study aims to improve our understanding of maternal and child health generally, but your personal health information will be kept confidential.

How to find out more

Lise Laclautre

promo_interne_drci@chu-clermontferrand.fr +33473754963 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.