Clinical trial NCT04173559: Sleep and Tracking Effects in Pregnancy Study
Official title: Improving Perinatal Outcomes Through Activity and Sleep Tracking
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Pregnancy Complications
Pregnancy Related
Weight Gain
Weight Change Trajectory
High Risk Pregnancy
Stress, Emotional
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2019-11-22
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 51
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Reduction in Perceived Maternal Stress
timeFrame: through delivery, an average of 7 months per participant
measure: Proportion of women with adverse perinatal outcomes
timeFrame: outcome will be ascertained at delivery
Secondary outcomes:
measure: Number of activity goals met by personalized activity level group
timeFrame: through delivery, an average of 7 months per participant
measure: Mean Daily steps
timeFrame: through delivery, an average of 7 months per participant
measure: Median Daily steps
timeFrame: through delivery, an average of 7 months per participant
measure: Mean 'Moderate' or greater physical activity
timeFrame: through delivery, an average of 7 months per participant
measure: Median 'Moderate' or greater physical activity
timeFrame: through delivery, an average of 7 months per participant
measure: Mean Nightly sleep minutes
timeFrame: through delivery, an average of 7 months per participant
measure: Median Nightly sleep minutes
timeFrame: through delivery, an average of 7 months per participant
measure: Median resting heart rate parameters
timeFrame: through delivery, an average of 7 months per participant
measure: Mean Resting heart rate parameters
timeFrame: through delivery, an average of 7 months per participant
measure: Median Body composition change during study - total body water
timeFrame: through reassessment of body composition at 16 weeks after randomization, an average of 4 months per participant.
measure: Mean Body composition change during study - total body water
timeFrame: through reassessment of body composition at 16 weeks after randomization, an average of 4 months per participant.
measure: Median Body composition change during study - percent body fat
timeFrame: through reassessment of body composition at 16 weeks after randomization, an average of 4 months per participant.
measure: Mean Body composition change during study - percent body fat
timeFrame: through reassessment of body composition at 16 weeks after randomization, an average of 4 months per participant.
measure: Gestational weight gain
timeFrame: through delivery, an average of 7 months per participant
measure: Gestational weight gain, per week after study enrollment
timeFrame: through delivery, an average of 7 months per participant
measure: Proportion of women with gestational diabetes mellitus
timeFrame: through delivery, an average of 7 months per participant.
measure: Proportion of women with hypertensive complications of pregnancy
timeFrame: through 6 weeks' postpartum, an average of 7 months per participant
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Tracy A Manuck, MD
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1016/j.ajog.2004.01.027.
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(4):CD007145. doi: 10.1002/14651858.CD007145.pub2.
citation: 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;2015(6):CD007145. doi: 10.1002/14651858.CD007145.pub3.
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.
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. doi: 10.1161/01.HYP.0000072270.82815.91. Epub 2003 Apr 28.