Clinical Trial

Sleep-MOMagement: Improving Postpartum Sleep in First-time Mothers Through Tailored Behavioral Approaches.

Study acronym: SleepMOM
Recruiting
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Summary
The goal of this clinical trial is to find out if person-centered behavioral interventions can help first-time mothers sleep better after childbirth. The study compares two approaches-a behavioral sleep management program and a behavioral aerobic exercise program-to usual postpartum care for women experiencing insomnia symptoms. The main clinical outcome is insomnia severity. The study also evaluates economic outcomes, including healthcare use, work absenteeism, overall health utility. Participants will: * Receive one of the interventions or continue with usual care. * Keep a sleep diary, a diary on physical activity, and complete questionnaires about sleep, mood, daily functioning, psychosocial factors, and economic outcomes. * Follow the program instructions, which may include sleep strategies or guided aerobic training, depending on the group.
Protocol Amendment History 1 change
critical Recruitment opened 2026-04-07
Trial Details
NCT Number NCT07345065
Lead Sponsor De deyne Manon
Collaborators: Vrije Universiteit Brussel, KU Leuven
Conditions Insomnia
Enrollment 135 participants
Start Date 2026-01-01
Primary Completion 2028-04-01 (estimated)
Study Completion 2028-11-01 (estimated)
Updated on ClinicalTrials.gov 2026-04-06