Sleep and Tracking Effects in Pregnancy Study

NCT04173559 | Withdrawn

• 1 other identifier: 18-2434
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (17)

• Number of activity goals met by personalized activity level group

  through delivery, an average of 7 months per participant

• Mean Daily steps

  through delivery, an average of 7 months per participant

• Median Daily steps

  through delivery, an average of 7 months per participant

• Mean 'Moderate' or greater physical activity

  through delivery, an average of 7 months per participant

• Median 'Moderate' or greater physical activity

  through delivery, an average of 7 months per participant

Study Arms (2)

Usual care

NO INTERVENTION

Women randomized to this group will receive no guidance regarding exercise / activity / sleep during pregnancy.

Activity Intervention

EXPERIMENTAL

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

Behavioral: Activity Intervention

Interventions

Activity Intervention BEHAVIORAL

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.

Activity Intervention

Eligibility Criteria

• Age: 18 Years - 51 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (5)

• 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.

  PMID: 15343232 BACKGROUND

• 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.

  PMID: 22513947 BACKGROUND

• 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.

  PMID: 26068707 BACKGROUND

• 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.

  PMID: 23836014 BACKGROUND

• 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.

  PMID: 12719446 BACKGROUND

MeSH Terms

Conditions

Pregnancy Complications; Weight Gain; Body-Weight Trajectory; Stress, Psychological

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Study Officials

• Tracy A Manuck, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: November 20, 2019
• First Posted: November 22, 2019
• Study Start: May 1, 2023
• Primary Completion: May 14, 2025
• Study Completion: May 14, 2025
• Last Updated: February 10, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 12 to 36 months after initial publication
• Access Criteria: Access will be given provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.

Locations

US (1)