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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
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.
University of North Carolina
Chapel Hill, North Carolina, United States
Reduction in Perceived Maternal Stress
Perceived stress score will be calculated using a validated 10-question stress scale; score = 14 indicates moderate stress
Time frame: through delivery, an average of 7 months per participant
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.
Time frame: outcome will be ascertained at delivery
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
Time frame: through delivery, an average of 7 months per participant
Mean Daily steps
Mean number of daily steps; amount will be compared between randomization groups.
Time frame: through delivery, an average of 7 months per participant
Median Daily steps
median number of daily steps; amount will be compared between randomization groups.
Time frame: through delivery, an average of 7 months per participant
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.
Time frame: through delivery, an average of 7 months per participant
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.
Time frame: through delivery, an average of 7 months per participant
Mean Nightly sleep minutes
Mean number of sleep minutes per night; amount will be compared between randomization groups.
Time frame: through delivery, an average of 7 months per participant
Median Nightly sleep minutes
median number of sleep minutes per night; amount will be compared between randomization groups.
Time frame: through delivery, an average of 7 months per participant
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.
Time frame: through delivery, an average of 7 months per participant
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.
Time frame: through delivery, an average of 7 months per participant
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.
Time frame: through reassessment of body composition at 16 weeks after randomization, an average of 4 months per participant.
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.
Time frame: through reassessment of body composition at 16 weeks after randomization, an average of 4 months per participant.
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.
Time frame: through reassessment of body composition at 16 weeks after randomization, an average of 4 months per participant.
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.
Time frame: through reassessment of body composition at 16 weeks after randomization, an average of 4 months per participant.
Gestational weight gain
The amount of weight gained by each participant during pregnancy, in pounds. outcomes will be compared between randomization groups.
Time frame: through delivery, an average of 7 months per participant
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.
Time frame: through delivery, an average of 7 months per participant
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.
Time frame: through delivery, an average of 7 months per participant.
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.
Time frame: through 6 weeks' postpartum, an average of 7 months per participant
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