Sleep and Tracking Effects in Pregnancy Study
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- High Risk Pregnancy
- Pregnancy Complications
- Pregnancy Related
- Stress, Emotional
- Weight Change Trajectory
- Weight Gain
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Randomized Controlled TrialMasking: Single (Outcomes Assessor)Primary Purpose: Prevention
Participation Requirements
- Age
- Between 18 years and 51 years
- Gender
- Only males
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, ...
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.
Tracking Information
- NCT #
- NCT04173559
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Tracy A Manuck, MD University of North Carolina, Chapel Hill