Sleep and Tracking Effects in Pregnancy Study

Not Applicable

Not yet recruiting

• Conditions: Pregnancy Related; High Risk Pregnancy; Weight Gain; Pregnancy Complications; Weight Change Trajectory; Stress, Emotional
• Interventions: Behavioral: Activity Intervention

• Registration Number: NCT04173559
• Lead Sponsor: University of North Carolina, Chapel Hill

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2019-11-20
• Study First Submitted QC: 2019-11-20
• Study First Posted: 2019-11-22
• Status Verified: 2022-07
• Last Update Submitted: 2022-09-12
• Last Update Posted: 2022-09-13
• Study Start: 2023-05
• Primary Completion: 2025-05-14
• Study Completion: 2025-05-14

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 250

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Activity Intervention	Activity Intervention	Women randomized to this group will receive detailed information and reminders about physical activity and sleep in pregnancy. .

Primary Outcome Measures

Name	Time	Method
Reduction in Perceived Maternal Stress	through delivery, an average of 7 months per participant	Perceived stress score will be calculated using a validated 10-question stress scale; score = 14 indicates moderate stress
Proportion of women with adverse perinatal outcomes	outcome will be ascertained at delivery	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.

Secondary Outcome Measures

Name	Time	Method
Number of activity goals met by personalized activity level group	through delivery, an average of 7 months per participant	Proportion of weekly activity goals that were successfully met by women randomized to personalized activity group
Median Daily steps	through delivery, an average of 7 months per participant	median number of daily steps; amount will be compared between randomization groups.
Mean Daily steps	through delivery, an average of 7 months per participant	Mean number of daily steps; amount will be compared between randomization groups.
Proportion of women with hypertensive complications of pregnancy	through 6 weeks' postpartum, an average of 7 months per participant	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.
Median 'Moderate' or greater physical activity	through delivery, an average of 7 months per participant	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.
Mean Nightly sleep minutes	through delivery, an average of 7 months per participant	Mean number of sleep minutes per night; amount will be compared between randomization groups.
Median Nightly sleep minutes	through delivery, an average of 7 months per participant	median number of sleep minutes per night; amount will be compared between randomization groups.
Median Body composition change during study - total body water	through reassessment of body composition at 16 weeks after randomization, an average of 4 months per participant.	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.
Mean Body composition change during study - total body water	through reassessment of body composition at 16 weeks after randomization, an average of 4 months per participant.	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.
Mean 'Moderate' or greater physical activity	through delivery, an average of 7 months per participant	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.
Median resting heart rate parameters	through delivery, an average of 7 months per participant	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.
Mean Resting heart rate parameters	through delivery, an average of 7 months per participant	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.
Gestational weight gain, per week after study enrollment	through delivery, an average of 7 months per participant	The amount of weight gained per week by each participant, in pounds, between study enrollment and delivery. outcomes will be compared between randomization groups.
Median Body composition change during study - percent body fat	through reassessment of body composition at 16 weeks after randomization, an average of 4 months per participant.	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.
Gestational weight gain	through delivery, an average of 7 months per participant	The amount of weight gained by each participant during pregnancy, in pounds. outcomes will be compared between randomization groups.
Proportion of women with gestational diabetes mellitus	through delivery, an average of 7 months per participant.	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.
Mean Body composition change during study - percent body fat	through reassessment of body composition at 16 weeks after randomization, an average of 4 months per participant.	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.

Trial Locations

Locations (1)

University of North Carolina; 🇺🇸 Chapel Hill, North Carolina, United States