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

NCT06705712 | Recruiting

• 1 other identifier: 1-10-72-174-23
• Study Type: interventional
• Target: 530
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Exercise; Physical activity; Sedentary behaviour; Fertility; Spontaneous abortion; Preconception care; Fecundability; Time to pregnancy

Outcome Measures

Primary Outcomes (3)

• Physical activity

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

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

• 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.

  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

• 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.

  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

Other Outcomes (1)

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

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

Study Arms (2)

Control group: Usual physical activity habits

NO INTERVENTION

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.

Intervention group: Changing physical activity habits

EXPERIMENTAL

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.

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

Interventions

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.

Intervention group: Changing physical activity habits

Eligibility Criteria

• Age: 18 Years - 49 Years
• Gender Eligibility Details: To participate in the study, the participants must be females and registered with a Danish Civil Registration Number as a female. Participants must be trying to conceive with a male partner without fertility help.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Department of Clinical Epidemiology

Aarhus, 8200, Denmark

RECRUITING

Related Links

• Study website

MeSH Terms

Conditions

Abortion, Spontaneous; Pregnancy Complications; Motor Activity

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Behavior

Study Officials

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

  Department of Clinical Epidemiology, Aarhus University

  STUDY CHAIR

Central Study Contacts

Sissel Jessen Weissert, MD

CONTACT

+45 87 15 02 67; sw@clin.au.dk

Marie Dahl Jørgensen, MSPH

CONTACT

+45 8715 0151; mariedahl@clin.au.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: SnartForældre/Activity is designed as a two-armed randomized controlled trial, including 530 women, who are trying to conceive. Included participants will be randomized in a 1:1 ratio to an intervention group or a control group. The participates are followed during preconception for up to a year or until they conceive. The participants who conceive during the study period are followed during their first trimester of the pregnancy or until they experience a pregnancy loss. Collection of data for assessment of the outcomes was through bimonthly follow-up questionnaires linked with registry data. Time frames and methods for assessment of outcomes are specified elsewhere.

Study Record Dates

• First Submitted: October 29, 2024
• First Posted: November 26, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 28, 2025

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)