Sleep and Tracking Effects in Pregnancy Study

NCT ID: NCT04173559

Last Updated: 2025-02-10

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-31
• Study Completion Date: 2025-05-14

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Usual care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Activity Intervention

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

Group Type: EXPERIMENTAL

Activity Intervention

Intervention Type: 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.

Interventions

Activity Intervention

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 51 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tracy A Manuck, MD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

University of North Carolina

Chapel Hill, North Carolina, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 15343232 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22513947 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26068707 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23836014 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12719446 (View on PubMed)

Other Identifiers

18-2434

Identifier Type: -

Identifier Source: org_study_id