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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-49
SponsorUniversity of Aarhus

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Female

18-49 years

In a relationship with a male partner

Trying to conceive

Disqualifiers

Using birth control

Receiving fertility treatment

Have been trying to conceive for more than six months

Trial design

Design model

Parallel

Treatments tested in this trial

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

    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.

Treatment groups

530 Participants
are divided into 2 treatment groups
Group A: Control group: Usual physical activity habitsNo intervention 0 interventions
Group B: Intervention group: Changing physical activity habitsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Physical activity

Physical activity will be objectively measured continuously (24/7) using wrist-worn activity trackers with triaxial accelerometry.

Time frame
From randomization to end of study or censoring event, no more than 15 months
2

Time to pregnancy (TTP)

TTP will be estimated by using variables from baseline and follow-up questionnaires. In each follow-up questionnaire, women report the date of the first day of their last menstrual period (LMP), whether they are currently pregnant, and whether they experienced any other pregnancies (SAB, induced abortion, or ectopic pregnancy) since their last questionnaire. For irregularly cycling women, we estimate cycle length based on baseline LMP date, expected date of next menses, and LMP recorded during follow-up.

Time frame
From baseline until they report a pregnancy or a censoring event (12 cycles of follow-up, cessation of pregnancy attempt, initiation of fertility treatment, withdrawal or loss to follow-up), no more than 12 months
3

Spontaneous abortion

Spontaneous abortion (SAB), defined as an intrauterine pregnancy loss before week 22 of gestation, will be identified from both bimonthly follow-up questionnaires and registries. In follow-up questionnaires, women report if they have had a pregnancy loss since the date of the most recent completed questionnaire as well as the date of loss and the gestational age at loss. Using the civil registration number (CPR), we will retrieve data from the Danish National Patient Registry (DNPR) and the Danish Medical Birth Registry (DMBR) to identify SABs and induced abortions occurring after the baseline enrollment date. For SABs identified from both registry and questionnaire data, we will use data from the DNPR (based on early ultrasound fetometry or LMP) to ascertain the time of SAB.

Time frame
From reported pregnancy until spontaneous abortion or censoring event (≥22 weeks' gestation, emigration, medically induced abortion or ectopic pregnancy), no more than 22 weeks from study entry

Secondary outcomes

Other outcomes

1

A process evaluation assessing the implementation and mechanisms of impact of the SnartForældre.dk/Activity intervention

A mixed methods process evaluation using the UK Medical Research Council's process evaluation framework to assess implementation (reach, fidelity, and dose) and mechanisms of impact of the intervention. We will collect data through motivational conversations and activity trackers, which provide both qualitative and quantitative insights. Through motivational conversations with participants, we will capture their experiences, challenges, and suggestions regarding the intervention. This qualitative feedback helps us understand context-specific issues. Data from activity trackers will offer objective measures of participant behavior and engagement with the intervention, allowing us to identify trends, such as compliance and changes in activity levels, that may indicate whether the intervention is being followed as intended.

Time frame
From inclusion to end of study or censoring event, no longer than 2 years

Sponsors and contacts

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