Physical Activity, Fertility, and Spontaneous Abortion in Danish Couples Trying to Conceive

NCT ID: NCT06705712

Last Updated: 2025-01-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 530 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-01
• Study Completion Date: 2026-12-31

Brief Summary

Physical activity in both the preconception period and during pregnancy may enhance the probability of getting pregnant and reduce the risks of complications during pregnancy. Adults, including pregnant women without complications, are recommended to be physically active for at least 30 minutes per day to maintain physical and mental health. Nonetheless, many women reduce their level of exercise during early pregnancy.

With this project, we will test the effectiveness of receiving motivational counseling on physical activity (PA) among women trying to conceive and during the first trimester of the pregnancy if they conceive. We will further investigate whether PA is associated with fecundability, spontaneous abortion (SAB) and other birth outcomes, i.e., gestational diabetes, preeclampsia, and birth weight.

Detailed Description

Infertility, defined as the failure to achieve pregnancy after 12 months of regular unprotected sexual intercourse, and spontaneous abortion (SAB) are significant public health problems, affecting up to 20% of reproductive age couples in the Western World. A large proportion of couples seek fertility treatment, which is not only an economic burden for the society, but also associated with adverse health effects among infertile couples. The causes of both infertility and SAB are multifactorial and identification of modifiable risk factors is an important public health goal.

According to the Danish Health Authority, adults are recommended to be physically active for at least 30 minutes per day, to undertake muscle-strengthening activities on two or more days per week and to reduce sedentary time. The same applies for pregnant women without complications. However, only 15-38% of pregnant women adhere to the recommendations for PA and many women reduce their level of exercise during early pregnancy compared with pre-pregnancy. Yet, maternal health in both the preconception period and during pregnancy is critical to avoid complications during pregnancy and for the long-term health of mother and child.

We therefore aim to investigate the association between PA, fecundability (i.e., the average per-cycle probability of conception), and SAB. An efficient web-based infrastructure to recruit, follow, and collect comprehensive data has already been developed. In the ongoing prospective cohort study, SnartForældre.dk (SF), we investigate fecundability and SAB according to demographic, behavioral, environmental, and medical factors and have enrolled more than 10,000 women and 1,700 of their male partners who are trying to conceive without fertility treatment.

In the present SF sub-study, SnartForældre.dk/Aktivitet, we aim to conduct a two-armed randomized controlled trial with 500 women included, to investigate the effectiveness of receiving motivational counseling on physical activity (PA) among women trying to conceive and during the first trimester of the pregnancy if they conceive. We will further investigate whether PA is associated with fecundability, spontaneous abortion (SAB) and other birth outcomes, i.e., gestational diabetes, preeclampsia, and birth weight. As we will be able to combine self-reported data, objectively measured data on PA, and high-quality Danish registry data, we have a unique possibility to evaluate the impact of PA on fecundability and SAB, as well as other pregnancy complications and birth outcomes, in a way that is hardly possible in any other country.

The study will provide important knowledge that will be of interest for the scientific world, health professionals, and for couples who suffer from infertility or experience SABs.

Conditions

Fertility; Fecundability; Time-to-Pregnancy; Spontaneous Abortion; Pregnancy Outcome; Pregnancy Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Control group: Usual physical activity habits

The participants will receive a wrist-worn activity tracker (Garmin VívoSmart 5) including clear instructions on how to use the tracker and how to connect to a software (Fitrockr). We ask the participants to wear the tracker 24/7 during the period they are trying to conceive and during the first trimester of their pregnancy if they conceive within 12 months to measure physical activity. Participants in the control group will not receive any PA feedback.

Participants are advised to maintain their usual activity habits.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention group: Changing physical activity habits

The participants will receive a wrist-worn activity tracker (Garmin VívoSmart 5) including clear instructions on how to use it. They will be asked to wear the tracker 24/7 during the period they are trying to conceive plus the first trimester of their pregnancy. They will receive information material on the Danish national guidelines on PA, health benefits from PA, and suggestions on how to reduce sedentary behavior and increase daily activity. Based on the current PA level, they are asked to set personal goals to meet the PA recommendations and to split up sedentary behavior. They will receive a phone call two and five weeks after they received the activity tracker, to stimulate the participant's motivation to be physically active, to set goals for maintaining or increasing PA and to facilitate a revision of the goals if needed.

The conversations will be inspired by motivational interviewing and the principles of this motivational technique.

Group Type: EXPERIMENTAL

Use of activity trackers and motivational conversations to enhance focus on physical activity among women trying to conceive.

Intervention Type: BEHAVIORAL

All participants will receive a wrist-worn activity tracker (Garmin VívoSmart 5) which will be connected with an application, Fitrockr. Data from the devices will be linked to data from the Snartforældre-questionnaires. The participants are asked to wear the tracker 24/7 during preconception and during the first trimester of their pregnancy if they conceive within 12 months.

Participants will receive information material and be asked to set goals for their PA level. To follow-up on the goal setting, they will receive two phone calls, where the conversations will be inspired by motivational interviewing.

Interventions

Use of activity trackers and motivational conversations to enhance focus on physical activity among women trying to conceive.

All participants will receive a wrist-worn activity tracker (Garmin VívoSmart 5) which will be connected with an application, Fitrockr. Data from the devices will be linked to data from the Snartforældre-questionnaires. The participants are asked to wear the tracker 24/7 during preconception and during the first trimester of their pregnancy if they conceive within 12 months.

Participants will receive information material and be asked to set goals for their PA level. To follow-up on the goal setting, they will receive two phone calls, where the conversations will be inspired by motivational interviewing.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Female
• 18-49 years
• In a relationship with a male partner
• Trying to conceive

Exclusion Criteria

• Using birth control
• Receiving fertility treatment
• Have been trying to conceive for more than six months

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anne Sofie Dam Laursen, cand.scient, ph.d.,

Role: STUDY_CHAIR

Department of Clinical Epidemiology, Aarhus University

Locations

Department of Clinical Epidemiology

Aarhus, , Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Sissel Jessen Weissert, MD

Role: CONTACT

sw@clin.au.dk

+45 87 15 02 67

Marie Dahl Jørgensen, MSPH

Role: CONTACT

mariedahl@clin.au.dk

+45 8715 0151

Facility Contacts

Anne Sofie Dam Laursen, Assoc. Prof

Role: primary

asdl@clin.au.dk

+4587167237

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Related Links

https://snartforaeldre.dk/

Study website

Other Identifiers

1-10-72-174-23

Identifier Type: -

Identifier Source: org_study_id