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Sleep disruptions are common during pregnancy and associated with increased risk of adverse maternal outcomes such as preeclampsia, gestational diabetes, prolonged labor, and cesarean birth. Given the morbidity associated with poor sleep, cost-effective approaches to improving sleep that can be disseminated in community or clinical settings are needed. Personal health monitor (PHM) devices offer an opportunity to promote behavior change, but their acceptability and efficacy at improving sleep in pregnant women are unknown.
The goal of the paper is to describe the protocol for an ongoing pilot randomized controlled trial that aims to establish the feasibility, acceptability, and preliminary efficacy of using a PHM device (Shine 2, Misfit) to promote sleep during pregnancy.
The proposed pilot study is a 12-week, parallel arm, randomized controlled trial. Pregnant women, at 24 weeks gestation, will be randomized at a 1:1 ratio to a 12-week sleep education plus PHM device group or a sleep education alone comparison group. The primary outcomes will be measures of feasibility (ie, recruitment, enrollment, adherence) and acceptability (ie, participant satisfaction). The secondary outcomes will be self-reported sleep quality and duration, excessive daytime sleepiness, fatigue, and depressive symptoms.
Recruitment for this study began in September 2017 and ended in March 2018. Data collection for the primary and secondary aims was completed in August 2018. We anticipate that the data analysis for primary and secondary aims will be completed by December 2019. The results from this trial will inform the development of a larger National Institutes of Health grant application to test the efficacy of an enhanced version of the sleep intervention that we plan to submit in the year 2020.
This study will be the first to apply a PHM device as a tool for promoting self-management of sleep among pregnant women. PHM devices have the potential to facilitate behavioral interventions because they include theory-driven, self-regulatory techniques such as behavioral self-monitoring. The results of the study will inform the development of a sleep health intervention for pregnant women.
ClinicalTrials.gov NCT03783663; https://clinicaltrials.gov/ct2/show/NCT03783663 (Archived by WebCite at http://www.webcitation.org/779Ou8hon)
DERR1-10.2196/12455
Sleep disruptions are common during pregnancy [
While sleep disruptions among pregnant women are often due to physical (eg, pain, nocturia, growing fetus) and hormonal changes [
Personal health monitors (PHMs) have grown in popularity, with an estimated 1 in 8 consumers now owning a PHM [
Here we describe the protocol for an ongoing pilot randomized controlled trial [NCT03783663] that aims to establish the feasibility, acceptability, and preliminary efficacy of using a PHM device (Shine 2, Misfit) to promote sleep during pregnancy. Specifically, the primary aim of the study will be to (1) establish the feasibility and acceptability of conducting a 12-week intervention for sleep self-management among pregnant women using a PHM device and (2) determine the feasibility of collecting data on sleep and physical activity using a PHM device. The secondary aim will be to determine the preliminary efficacy of the trial on improving self-reported sleep quality and nocturnal sleep duration and decreasing sleep disturbances, excessive daytime sleepiness, fatigue, and depressive symptoms.
This pilot study is a 12-week, parallel arm, randomized controlled trial. Participants will be randomized at a 1:1 ratio to a 12-week sleep education plus PHM device group or a sleep education alone comparison group at approximately 24 weeks gestation of pregnancy (
Participant flowchart.
At the time of recruitment (t0) (14 to 24 weeks gestation), participants will complete a screening survey to determine their eligibility. At 24 weeks gestation (t1), eligible participants will enroll in the study and complete a baseline survey to assess demographic characteristics and secondary outcome measures. Both researchers and participants will be blinded to group assignment at the baseline assessment and during the educational intervention. All participants will receive an individual 30-minute educational intervention on sleep hygiene during pregnancy delivered by a study registered nurse at enrollment. The focus on the sleep education will be to provide tips on how to achieve a better night’s sleep during pregnancy such as managing pregnancy weight gain with aerobic activity and keeping a consistent schedule. Participants will also receive a sleep hygiene brochure, adapted from a Massachusetts Lung and Allergy sleep clinic sleep hygiene brochure to include information specific to pregnancy. We piloted the development of the brochure through an online survey that asked about the usefulness of the information and overall aesthetics. We used similar recruitment approaches (ie, Facebook) and eligibility criteria to identify women in the brochure development pilot as will be used for the pilot intervention to ensure the feedback is appropriate for the target population. Based on the participant feedback, we made modifications to the brochure’s graphical design; the information content was deemed useful. After completing the baseline survey and sleep hygiene education, participants and researchers will be unblinded to the group assignment (t2). Assignments will be made prior to the start of recruitment by randomizing study identification (ID) numbers into intervention or control group using Web-based randomization software [
At 36 weeks gestation (t3), all participants will complete an in-person follow-up survey to assess the same secondary outcome measures as at t1. Participants will also complete a brief qualitative interview to determine their satisfaction with the sleep hygiene education and, for those in the intervention group, the self-monitoring intervention. Participants will complete a final follow-up phone survey approximately 2 to 4 weeks after delivery (t4).
We will recruit pregnant women who reside within approximately 50 miles of the University of Massachusetts Amherst campus. To be eligible to participate in the study, at the time of recruitment (t0) women must (1) be aged 18 years or older, (2) be 14 to <24 completed weeks gestation, (3) have no known maternal or fetal complications, (4) have a mobile phone compatible with the study PHM device, (5) have internet access, (6) be English speaking, and (7) be receiving prenatal care. We will exclude women with preexisting diabetes mellitus, hypertension, or a diagnosed sleep disorder, as some research demonstrated that associations between gestational diabetes and hypertension and a preexisting diagnosed sleep disorder would bias study results [
Recruitment will be conducted through advertisements posted (1) at local commercial and community centers frequented by pregnant women in western MA, (2) at a women’s health clinic in western MA, (3) at community centers with diverse memberships such as churches, and (4) on Facebook and Craigslist. The study nurse will also recruit participants in person in the waiting room of the women’s health clinics at the University of Massachusetts Medical Center. During screening/enrollment, we will document the source of recruitment for each participant.
The conceptual framework for the intervention is based on a meta-regression of lifestyle (ie, healthy eating and physical activity) interventions among adults by Michie et al [
The intervention group will be given a Shine 2 to monitor sleep throughout the 12-week intervention period. The Shine 2 is a triaxial accelerometer that can be worn on the wrist, waist, neck, pocket, or shoe. The Shine 2 measures steps, intensity, energy expenditure, distance traveled, and sleep duration using a proprietary algorithm. The Shine 2 was selected because it can be worn continuously (even during water-based activities), does not require charging (approximate 6-month battery life), and does not require participants to set the device to sleep mode in order to capture sleep patterns, features that may improve adherence to the intervention. The Shine 2 has been shown to provide equivalent estimates of total sleep time as in-lab polysomnography (
Participants will be instructed to wear the device on the wrist, which is better for capturing sleep than the other wear locations. Participants will be instructed on how to self-monitor total sleep time and select a goal for that behavior.
Misfit Shine 2 dashboard displaying the previous night’s sleep duration and self-selected sleep goal.
Misfit Shine 2 dashboard displaying weekly trend of sleep duration and self-selected sleep goal.
The sleep hygiene education session will be provided to both groups by the study nurse. To increase fidelity, a specific protocol for delivering the education to each group will be developed by the principal investigator, and the study nurse will be trained by the principal investigator on the protocol. The delivery of education to study participants will be audio recorded with a digital recorder. The principal investigator will listen to each recording to ensure that participants are receiving the same information per the protocol. In the event that deviation from the protocol is noted, the principal investigator and study nurse will meet to review and retrain on the protocol.
At t0, participants will be asked how they learned about the study (eg, Facebook, community center), with follow-up questions to gather specific details as necessary. The frequency and percentage of participants recruited by each recruitment method will be calculated. We will present descriptive data on the number screened, eligible, and randomized from each source.
Retention may be a challenge due to the longitudinal nature of the study. Each participant will be asked to provide multiple contact methods. Increasing incentives will be built into the study at each data collection time point ($20, $30, and $40 gift cards) to encourage retention for both the intervention and control groups. Participants in the intervention arm will keep the Shine 2 device at the study end. Participants in the control arm will be offered a Shine 2 at the study end. The ability to successfully contact participants, deliver the intervention, and collect data at each time point will be recorded to calculate the percentage of participants retained.
To evaluate participant retention with the intervention protocol, the study team will take two actions. First, we will track sleep data weekly for each participant by viewing their sleep log in the study Gmail account. Then, if a lack of data in the sleep log suggests that the participants are not wearing the monitor daily, we will call the participants to find out why they are not using the device, help them problem solve any issues, and encourage them to continue with study adherence.
Schedule of study assessments for primary and secondary outcomes.
Characteristics | Assessment | |||||
Screening/enrollment | Baseline | Active intervention | ||||
t0 | t1 | t2 | t3 | |||
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Eligibility screen | X |
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Informed consent | X |
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Allocation |
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X |
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Retention |
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X | ||
Participant satisfaction |
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X | ||
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Sleep quality and duration |
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X |
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X | ||
Sleep disturbances |
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X |
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X | ||
Excessive daytime sleepiness |
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X |
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X | ||
Fatigue |
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X |
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X | ||
Depressive symptoms |
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X |
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X |
Participants in both groups will be asked to complete a semistructured interview at the 12-week follow-up data collection meeting (t3). The interview questions will ask participants about their sleep, barriers and facilitators of sleep, and whether the brief sleep counseling was helpful. Women in the intervention group will additionally be asked about their experience wearing the Shine 2, their likes, dislikes, and whether they believe it would be helpful to other pregnant women.
The Pittsburgh Sleep Quality Index (PSQI) will be used to measure sleep quality and duration [
The PROMIS Short Form v1.0–Sleep Disturbance 6a will be used to measure sleep disturbances [
The Epworth Sleepiness Scale is an 8-item measure of daytime sleepiness [
The PROMIS Fatigue Short Form 4a will be used to measure fatigue. This 4-item scale measures fatigue in the past seven days with a 5-point Likert scale [
Two scales will be used to measure depressive symptoms in the past seven days. The PROMIS Depression Short Form 6a is a 6-item scale scored by summing responses for all items, with higher scores indicating higher depressive symptoms. It has been validated for use with several chronic illnesses [
We will collect information on demographic characteristics and eating habits. Demographic characteristics will include age, ethnic background, racial background, relationship status, level of education, employment status, hours worked per week, and income level. Eating habits will be measured using the Dietary Targets Monitor, a 9-item self-report questionnaire assessing consumption of fruits, vegetables, starchy foods, and other types of foods such as meat and fish [
We will use descriptive statistics to determine the feasibility and acceptability of the pilot intervention. Specifically, we describe recruitment and dropout rates in each group and noncompliance with the intervention among the intervention group only. To assess noncompliance we will use data from the IFTTT applet to determine the proportion of days the monitor was worn during the study period. High compliance will be defined as wearing the monitor at least 80% of days during the study period.
Qualitative methods will be used to determine the acceptability of the intervention, using a qualitative descriptive design [
To examine the preliminary efficacy of the intervention, all secondary outcome variables will be modeled as continuous outcomes. We will compare baseline characteristics of the intervention groups to ensure randomization was successful. We will present the mean and standard deviation or median and interquartile range for each secondary outcome at baseline and postintervention. A paired
Recruitment for this study began in September 2017 and ended in March 2018. Data collection for the primary and secondary aims was completed in August 2018. We anticipate that the data analysis for primary aims, evaluating the feasibility and acceptability of the intervention, will be completed by July 2019. We anticipate that the data analysis on the secondary aims, examining the preliminary efficacy of the trial on sleep quality and duration, sleep disturbance, excessive daytime sleepiness, fatigue, and depressive symptoms, will be completed by December 2019. The results from this trial will inform the development of a larger National Institutes of Health grant application to test the efficacy of an enhanced version of the sleep intervention that we plan to submit in the year 2020.
This 12-week, parallel arm, pilot randomized controlled trial proposes to establish the feasibility and acceptability of conducting a 12-week intervention for sleep self-management among pregnant women using a PHM device and determine the feasibility of collecting data on sleep and physical activity using a PHM device. Secondarily, the trial will determine the preliminary efficacy of the trial on improving self-reported sleep quality and nocturnal sleep duration and decreasing sleep disturbances, excessive daytime sleepiness, fatigue, and depressive symptoms. This study is novel because it will be the first to apply a PHM device as a tool for promoting self-management of sleep among pregnant women. We anticipate that at least 80% of participants will wear the PHM device daily throughout the study period and report high satisfaction with the intervention. Further, we anticipate that participant feedback will inform the design of a larger randomized controlled trial aiming to improve sleep quality and duration during pregnancy using a PHM device.
Specifically, findings from the pilot study will inform the recruitment and intervention implementation, including strategies to increase adherence. As far as refining our recruitment plan, we will learn important information about the demographic characteristics (eg, race and ethnicity, socioeconomic status, baseline sleep characteristics) of the sample population. Our recruitment goal is for at least 20% of the sample to come from racial and ethnic minority groups. If we fail to recruit a racial and ethnically diverse sample, we will identify specific recruitment barriers and refine our recruitment strategy. Second, we will identify which recruitment approach (eg, Facebook, flyering at local clinics) is the most cost effective. Third, identifying weekly and monthly recruitment yields will allow us to determine if our recruitment strategy could feasibly enroll participants for an adequately powered study. We will need to consider the length of the recruitment period, adding clinical sites, and budgetary considerations for the larger trial.
In addition to recruitment, participant adherence is another critical challenge this feasibility study will help inform. Since previous studies did not use a PHM device specifically to monitor sleep, we would like to first address if pregnant women will wear them for this purpose. Through the IFTTT app, we will be able to identify when the monitor is not worn and elicit feedback from participants on any barriers to wearing the device. If specific benchmarks for retention are not met (>80%), we will refine our current approach (eg, incentive, engagement strategies) to address any challenges that exist.
Last, this feasibility trial will provide important information about the implementation of the intervention. The intervention was meant to be a low-contact intervention to be consistent with the limited time resources in a clinic setting. Through the participant satisfaction interview, we will determine whether the initial counseling session and sleep brochure address challenges specific to pregnant women. Concerning the instruments for the intervention (Shine 2), we will learn if there are specific features participants liked or did not like about the device and the extent to which participants used the device to self-monitor their sleep. Identifying specific features will allow us to be responsive to rapid changes in technology, steering us to select a device that contains features participants find particularly helpful. More generally, we will learn if wearing the PMH device serves as a motivator to participants to monitor their sleep more closely and identify behaviors affecting their sleep.
Given the prevalence and morbidity of sleep disturbances during pregnancy, it is essential to identify cost-effective approaches to promote better sleep in this group. Wearable devices have the potential to facilitate behavioral interventions as they include theory-driven self-regulatory techniques such as behavioral self-monitoring. There has been increasing interest in incorporating PMH devices into clinical settings. For example, PHM devices have been used to monitor inpatient recovery [
This study will, however, have important limitations that warrant discussion. First, the study requires that participants have access to mobile phones compatible with the study monitor; therefore, individuals of low socioeconomic status may potentially be excluded from the study [
This pilot feasibility study will provide the foundation for a larger trial that aims to improve sleep during pregnancy using a PHM device. The findings from this feasibility and acceptability pilot will provide valuable feedback on the design and implementation of the intervention.
identification
personal health monitor
Pittsburgh Sleep Quality Index
Rebecca Spencer provided feedback on the PHM device selection and sleep assessment methods. The study was funded by the National Institute of Nursing Research (P20NR016599).
All the authors contributed to the various stages of this study. MP conceived of the study design, researched the literature, and provided feedback on all drafts of the manuscript. MH participated in the design of the study, researched the literature, and drafted the manuscript. FI contributed to study design and brochure development. All the authors read and commented on the drafts and approved of the final version of the manuscript for submission.
None declared.