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

NCT ID: NCT03783663

Last Updated: 2018-12-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-01
• Study Completion Date: 2018-08-27

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Sleep education plus Misfit Shine 2

This arm receives sleep education from the study nurse and also receives a Misfit Shine 2 to wear for 12 weeks to self-monitor sleep.

Group Type: EXPERIMENTAL

Misfit Shine 2

Intervention Type: BEHAVIORAL

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.

sleep education only

This arm receives only sleep education from the study nurse.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. be age ≥ 18

2. 14 to <24 completed weeks gestation of pregnancy

2) have no known maternal or fetal complications 3) have a smartphone compatible with the study PHM device 4) have internet access 5) be English speaking 6) be receiving prenatal care.

Exclusion Criteria

1. pre-existing diabetes mellitus or hypertension

2. diagnosed sleep disorder

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

Sponsors

University of Pittsburgh

OTHER

Sponsor Role: collaborator

University of Massachusetts, Amherst

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Massachusetts Amherst

Amherst, Massachusetts, United States

Countries

United States

References

Hawkins M, Iradukunda F, Paterno M. Feasibility of a Sleep Self-Management Intervention in Pregnancy Using a Personalized Health Monitoring Device: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2019 May 29;8(5):e12455. doi: 10.2196/12455.

Reference Type: DERIVED

PMID: 31144670 (View on PubMed)

Other Identifiers

2017-3846

Identifier Type: -

Identifier Source: org_study_id