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Sleep Self-management in Pregnancy Using a Personalized Health Monitoring Device

NCT03783663 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2018-12-21

No results posted yet for this study

Summary

Pregnancy-associated sleep disorders are a common acute experience in pregnancy experienced by up to 82% of women. Sleep disorders are associated with increased risk for pre-eclampsia, gestational diabetes, longer labor, cesarean birth, and postpartum depression, and are higher among pregnant women of lower socioeconomic status. Traditional clinical management of sleep disorders in pregnancy includes education and counseling on sleep hygiene and sleep positioning, dietary modifications, relaxation, iron supplementation, weight management, and physical activity, yet education-based behavioral interventions show minimal effectiveness for improving sleep among pregnant women. These methods typically do not incorporate objective self-monitoring, which is an important behavior change technique. In pregnancy, objective self-monitoring on a day-to-day basis is particularly important as sleep disorders may worsen as pregnancy progresses.

Computer-based personalized health monitoring (PHM) devices may serve as an effective tool with which pregnant women can self-manage sleep through incorporation of regular feedback. This strategy may be beneficial not only for women with pregnancy-associated sleep disorders but also for pregnant women with less severe sleep disruptions that experience daytime sleepiness, fatigue, and decreased quality of life. PHM devices have been used to promote weight loss, diet, and physical activity changes but no studies have specifically targeted sleep among pregnant women. The purpose of this pilot study is to establish the feasibility and acceptability of conducting a 12-week intervention for sleep self-management with pregnant women using a PHM device, in order to refine the intervention for a larger, randomized trial.

Conditions

  • Pregnancy
  • Sleep

Interventions

BEHAVIORAL

Misfit Shine 2

The intervention group was given a Misfit Shine 2 to monitor sleep throughout the 12-week intervention period. Participants were instructed to wear the device on the wrist, which is better for capturing sleep than the other wear locations. Participants were instructed on how to self-monitor total sleep time and select a goal for that behavior. Further, participants were asked to view feedback on their sleep time daily on the Misfit smartphone app, which they used to monitor their progress toward achieving their behavioral goals.

Sponsors & Collaborators

  • University of Pittsburgh

    collaborator OTHER

  • University of Massachusetts, Amherst

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-09-01
Primary Completion
2018-07-18
Completion
2018-08-27

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03783663 on ClinicalTrials.gov