Sleep and Tracking Effects in Pregnancy Study

Pregnancy Related Clinical Trial

— STEP  

Official title:

Improving Perinatal Outcomes Through Activity and Sleep Tracking

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04173559
• Other study ID #: 18-2434
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2023
• Est. completion date: May 14, 2025

Study information

• Verified date: July 2022
• Source: University of North Carolina, Chapel Hill
• Contact: Tracy A Manuck, MD
• Phone: 919-966-1601
• Email: tmanuck[@]med.unc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Purpose: The investigators hypothesize that a simple, personalized, smartphone-based activity intervention using a wrist-based activity tracker will help high risk pregnant women reduce their stress during pregnancy. Participants: Pregnant women enrolled in prenatal care at the University of North Carolina who have a documented moderate or high level of perceived stress ( ≥ 14) and are at high risk for adverse pregnancy outcomes due to body mass index of ≥ 30 kg/m2 or history of gestational hypertension, preeclampsia, intrauterine growth restriction, or preterm birth <37 weeks' in a prior pregnancy. Procedures: Women meeting inclusion criteria will be recruited through the University of North Carolina prenatal care clinics. They will be contacted for possible participation at regularly scheduled prenatal visits and/or ultrasound. They may also be contacted for possible participation by remote methods (e.g., Telehealth). Women who are enrolled will complete validated dietary, stress, sleep, and body image questionnaires. Enrolled women will then be randomized to receive standard obstetrical care or enhanced counseling. All participants will receive a wrist-based activity tracker. Maternal blood sample for biochemical markers of stress and gene expression will be obtained at the initial visit; a followup blood sample will be obtained later in pregnancy, and a small portion of the placenta saved at delivery. Maternal and neonatal outcomes will be compared between groups.

Description:

During pregnancy, women regularly interact with healthcare professionals, an often untapped resource and opportune time to minimize stress and optimize weight gain, nutrition, and activity, positively impacting outcomes and lifelong health. The overarching hypothesis of this study is that a simple, personalized, smartphone-based activity intervention using a wrist-based activity tracker will help high risk pregnant women increase their activity level during pregnancy, reduce stress, and optimize gestational weight gain and biometric parameters. Importantly, the investigators propose that women can be engaged in care via a simple, personalized text-message based intervention. Women will be enrolled early in pregnancy and followed prospectively. All women will receive a wrist-based activity tracker. Some women (those randomized to receive individualized counseling) will receive weekly text messages based on their activity and sleep in the prior week. Other women will not receive any specific instructions regarding activity level. The investigators will follow their outcomes prospectively. Biologic samples (including blood, urine, vaginal swabs, placental tissue) will be collected at enrollment and at delivery.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 250
• Est. completion date: May 14, 2025
• Est. primary completion date: May 14, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 51 Years

Eligibility

Inclusion Criteria:

• At high risk for adverse pregnancy outcomes, due to either body mass index = 30 kg/m^2, or a prior history of preeclampsia, intrauterine growth restriction or preterm birth prior to 37 weeks' gestation in a previous pregnancy and a perceived stress score of >/= 14 (10-question scale)
• Gestational age of 8.0 to 19.9 weeks' gestation using American College of Obstetricians and Gynecologists dating criteria (combination of ultrasound and menstrual dating, as available)
• Current singleton viable intrauterine pregnancy. Spontaneous reduction of twin to singleton gestation is allowable provided it occurred prior to 14 weeks' gestation.
• No structural abnormalities or aneuploidy
• Ability to communicate in and provide consent in English
• Maternal age 18 to 51 years of age
• Owns smartphone compatible with wrist-based activity tracker (over 200 devices supported)

Exclusion Criteria:

• Women pregnant with multifetal gestations
• Women who have a medical condition where a modest increase in low-impact activity is contraindicated (at the discretion of the woman's treating physician)
• Planned delivery prior to 36 weeks' of gestation
• Unwilling to wear wrist-based activity tracker for at least 6 out of 7 days per week

Related Conditions & MeSH terms

• Body Weight
• High Risk Pregnancy
• Pregnancy Complications
• Pregnancy Related
• Stress, Emotional
• Weight Change Trajectory
• Weight Gain

Intervention

Behavioral:
• Activity Intervention
After 1 week of baseline activity is obtained, participants will be contacted with personalized activity goals that are 10% higher than their previous weeks' activity levels. They will also receive feedback regarding sleep if they are not averaging at least 6 hours per night or if they are waking more than twice per night. Participants will also receive weekly text reminders and encouraging feedback, and will receive additional counseling in person at regularly scheduled prenatal visits until delivery.

Locations

Country	Name	City	State
United States	University of North Carolina	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

References & Publications (5)

Muktabhant B, Lawrie TA, Lumbiganon P, Laopaiboon M. Diet or exercise, or both, for preventing excessive weight gain in pregnancy. Cochrane Database Syst Rev. 2015 Jun 15;(6):CD007145. doi: 10.1002/14651858.CD007145.pub3. Review. — View Citation

Muktabhant B, Lumbiganon P, Ngamjarus C, Dowswell T. Interventions for preventing excessive weight gain during pregnancy. Cochrane Database Syst Rev. 2012 Apr 18;(4):CD007145. doi: 10.1002/14651858.CD007145.pub2. Review. Update in: Cochrane Database Syst Rev. 2015;(6):CD007145. — View Citation

Olson CM, Strawderman MS, Reed RG. Efficacy of an intervention to prevent excessive gestational weight gain. Am J Obstet Gynecol. 2004 Aug;191(2):530-6. — View Citation

Sorensen TK, Williams MA, Lee IM, Dashow EE, Thompson ML, Luthy DA. Recreational physical activity during pregnancy and risk of preeclampsia. Hypertension. 2003 Jun;41(6):1273-80. Epub 2003 Apr 28. — View Citation

Wolf HT, Owe KM, Juhl M, Hegaard HK. Leisure time physical activity and the risk of pre-eclampsia: a systematic review. Matern Child Health J. 2014 May;18(4):899-910. doi: 10.1007/s10995-013-1316-8. Review. Erratum in: Matern Child Health J. 2014 Oct;18(8):2020-3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in Perceived Maternal Stress	Perceived stress score will be calculated using a validated 10-question stress scale; score = 14 indicates moderate stress	through delivery, an average of 7 months per participant
Primary	Proportion of women with adverse perinatal outcomes	The investigators will define adverse pregnancy outcomes as a composite of preterm birth <37 weeks, intrauterine growth restriction, preeclampsia, and placental abruption; outcomes will be compared between randomization groups.	outcome will be ascertained at delivery
Secondary	Number of activity goals met by personalized activity level group	Proportion of weekly activity goals that were successfully met by women randomized to personalized activity group	through delivery, an average of 7 months per participant
Secondary	Mean Daily steps	Mean number of daily steps; amount will be compared between randomization groups.	through delivery, an average of 7 months per participant
Secondary	Median Daily steps	median number of daily steps; amount will be compared between randomization groups.	through delivery, an average of 7 months per participant
Secondary	Mean 'Moderate' or greater physical activity	Mean number of weekly minutes of 'moderate' or 'intense' physical activity as registered by the wrist-based activity monitor; amount will be compared between randomization groups.	through delivery, an average of 7 months per participant
Secondary	Median 'Moderate' or greater physical activity	median number of weekly minutes of 'moderate' or 'intense' physical activity as registered by the wrist-based activity monitor; amount will be compared between randomization groups.	through delivery, an average of 7 months per participant
Secondary	Mean Nightly sleep minutes	Mean number of sleep minutes per night; amount will be compared between randomization groups.	through delivery, an average of 7 months per participant
Secondary	Median Nightly sleep minutes	median number of sleep minutes per night; amount will be compared between randomization groups.	through delivery, an average of 7 months per participant
Secondary	Median resting heart rate parameters	The change in the median resting heart rate level and nadir of the resting heart rate (in beats per minute), between enrollment and delivery ; amount will be compared between randomization groups.	through delivery, an average of 7 months per participant
Secondary	Mean Resting heart rate parameters	The change in the mean resting heart rate level and nadir of the resting heart rate (in beats per minute), between enrollment and delivery ; amount will be compared between randomization groups.	through delivery, an average of 7 months per participant
Secondary	Median Body composition change during study - total body water	The change in median total body water measurements between enrollment and re-assessment at 8 and 16 weeks (as applicable, if still pregnant) after enrollment will be compared between randomization groups.	through reassessment of body composition at 16 weeks after randomization, an average of 4 months per participant.
Secondary	Mean Body composition change during study - total body water	The change in mean total body water measurements between enrollment and re-assessment at 8 and 16 weeks (as applicable, if still pregnant) after enrollment will be compared between randomization groups.	through reassessment of body composition at 16 weeks after randomization, an average of 4 months per participant.
Secondary	Median Body composition change during study - percent body fat	The change in median percent body fat measurements between enrollment and re-assessment at 8 and 16 weeks (as applicable, if still pregnant) after enrollment will be compared between randomization groups.	through reassessment of body composition at 16 weeks after randomization, an average of 4 months per participant.
Secondary	Mean Body composition change during study - percent body fat	The change in mean percent body fat measurements between enrollment and re-assessment at 8 and 16 weeks (as applicable, if still pregnant) after enrollment will be compared between randomization groups.	through reassessment of body composition at 16 weeks after randomization, an average of 4 months per participant.
Secondary	Gestational weight gain	The amount of weight gained by each participant during pregnancy, in pounds. outcomes will be compared between randomization groups.	through delivery, an average of 7 months per participant
Secondary	Gestational weight gain, per week after study enrollment	The amount of weight gained per week by each participant, in pounds, between study enrollment and delivery. outcomes will be compared between randomization groups.	through delivery, an average of 7 months per participant
Secondary	Proportion of women with gestational diabetes mellitus	The diagnosis of gestational diabetes mellitus during pregnancy, using standard criteria as set forth by American College of Obstetricians and Gynecologists. outcomes will be compared between randomization groups.	through delivery, an average of 7 months per participant.
Secondary	Proportion of women with hypertensive complications of pregnancy	The diagnosis of gestational hypertension, preeclampsia, or eclampsia, using standard American College of Obstetricians and Gynecologists diagnostic criteria. outcomes will be compared between randomization groups.	through 6 weeks' postpartum, an average of 7 months per participant