The Pregnancy 24/7 Cohort Study

Healthy Clinical Trial

Official title:

Sedentary Behavior, Physical Activity, Sleep, and Cardiovascular Risk in Pregnancy: the Pregnancy 24/7 Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04749849
• Other study ID #: 202002630
• Secondary ID: R01HL153095
• Status: Recruiting
• Start date: February 1, 2021
• Est. completion date: November 2025

Study information

• Verified date: March 2024
• Source: University of Iowa
• Contact: Karina Smith, MSN
• Phone: 319-335-7315
• Email: karina-smith[@]uiowa.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Moderate to vigorous intensity physical activity is known to reduce the risk of hypertensive disorders of pregnancy and other adverse pregnancy outcomes that increase future maternal cardiovascular disease risk (2018 Physical Activity Guidelines Advisory Committee, 2018; Davenport et al., 2018), yet less than 25% of pregnant women meet public health physical activity guidelines (Hesketh & Evenson, 2016). More than 95% of the 24-hour day is spent in sedentary behavior, sleep, or light-intensity activity; however, the impacts of these lower intensity activities on adverse pregnancy outcomes are unknown. This multi-site observational cohort study (N=500) will leverage state-of-the-art, 24-hour behavior assessment in each trimester of pregnancy and examine associations with adverse pregnancy outcomes to inform guidelines and future interventions designed to improve women's pregnancy and long-term cardiovascular health.

Description:

The overall goal of this study is to use state-of-the-art monitors to objectively measure the 24-hour behavioral cycle (sedentary behavior, sleep, and physical activity) in each trimester of pregnancy, and to examine associations of these behaviors with hypertensive disorders of pregnancy and other adverse pregnancy outcomes linked with future cardiovascular disease (CVD) risk. For this, 500 women in early pregnancy will be recruited to take part in a multi-site (Universities of Iowa and Pittsburgh) cohort study. Women will wear two state-of-the-art devices for seven days in each trimester of pregnancy to assess sedentary behavior and physical activity (activPAL micro 3) as well as sleep (ActiWatch Spectrum Plus). Hypertensive disorders of pregnancy and other adverse outcomes will be obtained through medical chart abstraction. This project will inform guidelines on optimal 24-hour behavioral patterns in pregnancy, as well as lay the foundation for future studies testing behavioral interventions in pregnancy to achieve optimal outcomes and improve women's long-term cardiovascular health.

Specific Aims:

AIM 1: Examine associations of sedentary behavior patterns with hypertensive disorders of pregnancy. Hypothesis: Women with a consistently high sedentary behavior pattern across trimesters will have higher incidence of gestational hypertension/preeclampsia, after adjustment for MVPA.

AIM 2: Examine associations of sleep patterns with hypertensive disorders of pregnancy. Hypothesis: Women with short sleep duration or poor sleep quality patterns across trimesters will have higher incidence of gestational hypertension/preeclampsia, after adjustment for MVPA.

AIM 3: Determine optimal 24-hour behavioral patterns during pregnancy to reduce the risk of hypertensive disorders of pregnancy. Hypothesis: Statistically reallocating time in sedentary behavior for LPA or MVPA, but not sleep (among adequate duration sleepers), will be associated with lower incidence of gestational hypertension/preeclampsia.

Significance: Pregnancy is a critical period for future cardiovascular health where unmasked cardiovascular disease (CVD) risk factors contribute to the development of maternal CVD later in life (Catov, 2015). The American Heart Association (AHA) now recognizes adverse pregnancy outcomes, including gestational hypertension and preeclampsia as key risk factors for CVD (Mosca et al., 2011). CVD remains the leading cause of mortality among women in the United States, accounting for one-third of all deaths (Benjamin et al., 2018). Stagnant CVD rates in young women are a particular public health problem. While overall CVD mortality rates have decreased over the last 20 years, mortality rates in women younger than 55 years have plateaued (Benjamin et al., 2018; Wilmot, O'Flaherty, Capewell, Ford, & Vaccarino, 2015). In order to reduce the burden of CVD, it is essential to focus on populations who are more likely to develop CVD risk factors, including women of reproductive age. Identifying modifiable behavioral factors that are associated with adverse pregnancy outcomes could help prevent these conditions and the long-term risk they bring to women.

Based on guidelines, women during pregnancy should generally 'move more and sit less' throughout the day (2018 Physical Activity Guidelines Advisory Committee, 2018). While there is currently insufficient evidence to define specific quantitative targets for limiting sedentary behavior in the general population or pregnant women, the 2018 Physical Activity Guidelines Advisory Committee highlighted sedentary behavior and pregnancy as two key topics in need of further research. The American College of Obstetricians and Gynecologists (ACOG) also does not have sedentary behavior guidelines during pregnancy, although growing evidence suggests prescribed bed rest may actually increase the risk of adverse pregnancy outcomes, rather than decreasing risk as previously thought (Matenchuk et al., 2019). Guidelines also suggest that pregnant women should sleep 7 to 9 hours per night on a regular basis (Watson et al., 2015). Yet, uncertainty remains about the health effects of short or long sleep duration during pregnancy, as well as how sleep quality influences pregnancy outcomes.

In Aim 1, the proposed research will inform quantitative guidelines for sedentary behavior patterns and the development of cardiovascular risk during pregnancy. Aim 2 will address existing gaps by evaluating objectively-measured sleep quantity and quality to understand nuances in sleep across pregnancy and implications for health outcomes. As established guidelines recommend pregnant women get 150 minutes of aerobic MVPA per week or approximately 20-30 minutes per day, this is not the focus of the current study. However, MVPA is an important component of the 24-hour behavioral cycle and must be assessed to understand which 24-hour behavioral patterns are most associated with optimal cardiovascular health during pregnancy, as proposed in Aim 3. Our primary outcome of interest is hypertensive disorders that develop during pregnancy (gestational hypertension and preeclampsia) given the high and rising prevalence of these conditions, strong association with future maternal CVD, and promising pilot data indicating that sedentary behavior may be associated with these conditions, even after adjustment for MVPA.

Examining the dynamic interplay of sedentary behavior, sleep, and physical activity (conceptualized as a 24-hour behavioral cycle) is critical to determine optimal patterns for pregnancy health. Given that there is a finite amount of time in a day, increasing time in one behavior requires decreasing time in another behavior. The effects of sedentary behavior, sleep, and physical activity on health outcomes are not only dependent on each behavior, but also on the behavior that they displace (Mekary, Willett, Hu, & Ding, 2009). While these behaviors are often studied in isolation, this new paradigm considers the importance of examining the combined role of sedentary behavior, sleep, and physical activity on health outcomes (Buman et al., 2014). Emerging statistical methods to test hypotheses within finite time constraints will allow us to better understand the full 24-hour behavioral cycle and how these activity domains can be coupled and leveraged for health promotion and disease prevention. This study will address a critical gap in knowledge by examining how the 24-hour behavioral cycle is related to hypertensive disorders of pregnancy or other adverse outcomes that increase CVD risk.

In summary, preventing hypertensive disorders of pregnancy and other adverse outcomes is a potentially potent public health approach to reduce the burden of CVD in women. In the context of increasing incidence and limited treatment options, there is a critical need to identify novel, modifiable intervention targets that could prevent adverse pregnancy outcomes and improve women's cardiovascular health.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: November 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion:

Adult subjects inclusion criteria:

• Pregnant, <13 weeks gestation

• 18-45 years of age

Exclusion:

Adult subjects exclusion criteria:

• Taking medications for hypertension or diabetes

• Medical condition that severely limits physical activity (cannot walk ½ mile or climb 2 flights of stairs)

• Undergoing treatment for sleep disorders (medication, behavioral treatment, or mechanical therapies)

• Other serious medical condition (such as systemic lupus, chronic renal disease, hepatitis)

Minor subjects inclusion criteria:

• Mother took part in the Pregnancy 24/7 Study and consented to medical chart abstraction of child

Related Conditions & MeSH terms

• Healthy

Locations

Country	Name	City	State
United States	University of Iowa	Iowa City	Iowa
United States	Bethany Barone Gibbs	Morgantown	West Virginia
United States	University of Pittsburg	Pittsburgh	Pennsylvania

Sponsors (4)

Lead Sponsor	Collaborator
Kara Whitaker	National Heart, Lung, and Blood Institute (NHLBI), University of Pittsburgh, West Virginia University

Country where clinical trial is conducted

United States, 

References & Publications (11)

2018 Physical Activity Guidelines Advisory Committee. (2018). Physical Activity Guidelines Advisory Committee Scientific Report. Washington DC: Department of Health and Human Services.

Benjamin EJ, Virani SS, Callaway CW, Chamberlain AM, Chang AR, Cheng S, Chiuve SE, Cushman M, Delling FN, Deo R, de Ferranti SD, Ferguson JF, Fornage M, Gillespie C, Isasi CR, Jimenez MC, Jordan LC, Judd SE, Lackland D, Lichtman JH, Lisabeth L, Liu S, Longenecker CT, Lutsey PL, Mackey JS, Matchar DB, Matsushita K, Mussolino ME, Nasir K, O'Flaherty M, Palaniappan LP, Pandey A, Pandey DK, Reeves MJ, Ritchey MD, Rodriguez CJ, Roth GA, Rosamond WD, Sampson UKA, Satou GM, Shah SH, Spartano NL, Tirschwell DL, Tsao CW, Voeks JH, Willey JZ, Wilkins JT, Wu JH, Alger HM, Wong SS, Muntner P; American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2018 Update: A Report From the American Heart Association. Circulation. 2018 Mar 20;137(12):e67-e492. doi: 10.1161/CIR.0000000000000558. Epub 2018 Jan 31. No abstract available. Erratum In: Circulation. 2018 Mar 20;137(12 ):e493. — View Citation

Buman MP, Winkler EA, Kurka JM, Hekler EB, Baldwin CM, Owen N, Ainsworth BE, Healy GN, Gardiner PA. Reallocating time to sleep, sedentary behaviors, or active behaviors: associations with cardiovascular disease risk biomarkers, NHANES 2005-2006. Am J Epidemiol. 2014 Feb 1;179(3):323-34. doi: 10.1093/aje/kwt292. Epub 2013 Dec 6. — View Citation

Catov JM. Pregnancy as a Window to Cardiovascular Disease Risk: How Will We Know? J Womens Health (Larchmt). 2015 Sep;24(9):691-2. doi: 10.1089/jwh.2015.5363. Epub 2015 Jun 30. No abstract available. — View Citation

Davenport MH, Ruchat SM, Poitras VJ, Jaramillo Garcia A, Gray CE, Barrowman N, Skow RJ, Meah VL, Riske L, Sobierajski F, James M, Kathol AJ, Nuspl M, Marchand AA, Nagpal TS, Slater LG, Weeks A, Adamo KB, Davies GA, Barakat R, Mottola MF. Prenatal exercise for the prevention of gestational diabetes mellitus and hypertensive disorders of pregnancy: a systematic review and meta-analysis. Br J Sports Med. 2018 Nov;52(21):1367-1375. doi: 10.1136/bjsports-2018-099355. — View Citation

Hesketh KR, Evenson KR. Prevalence of U.S. Pregnant Women Meeting 2015 ACOG Physical Activity Guidelines. Am J Prev Med. 2016 Sep;51(3):e87-9. doi: 10.1016/j.amepre.2016.05.023. No abstract available. — View Citation

Matenchuk B, Khurana R, Cai C, Boule NG, Slater L, Davenport MH. Prenatal bed rest in developed and developing regions: a systematic review and meta-analysis. CMAJ Open. 2019 Jul 9;7(3):E435-E445. doi: 10.9778/cmajo.20190014. Print 2019 Jul-Sep. — View Citation

Mekary RA, Willett WC, Hu FB, Ding EL. Isotemporal substitution paradigm for physical activity epidemiology and weight change. Am J Epidemiol. 2009 Aug 15;170(4):519-27. doi: 10.1093/aje/kwp163. Epub 2009 Jul 7. — View Citation

Mosca L, Benjamin EJ, Berra K, Bezanson JL, Dolor RJ, Lloyd-Jones DM, Newby LK, Pina IL, Roger VL, Shaw LJ, Zhao D, Beckie TM, Bushnell C, D'Armiento J, Kris-Etherton PM, Fang J, Ganiats TG, Gomes AS, Gracia CR, Haan CK, Jackson EA, Judelson DR, Kelepouris E, Lavie CJ, Moore A, Nussmeier NA, Ofili E, Oparil S, Ouyang P, Pinn VW, Sherif K, Smith SC Jr, Sopko G, Chandra-Strobos N, Urbina EM, Vaccarino V, Wenger NK. Effectiveness-based guidelines for the prevention of cardiovascular disease in women--2011 update: a guideline from the american heart association. Circulation. 2011 Mar 22;123(11):1243-62. doi: 10.1161/CIR.0b013e31820faaf8. Epub 2011 Feb 14. No abstract available. Erratum In: Circulation. 2011 Jun 7;123(22):e624. Circulation. 2011 Oct 18;124(16):e427. — View Citation

Watson NF, Badr MS, Belenky G, Bliwise DL, Buxton OM, Buysse D, Dinges DF, Gangwisch J, Grandner MA, Kushida C, Malhotra RK, Martin JL, Patel SR, Quan SF, Tasali E. Recommended Amount of Sleep for a Healthy Adult: A Joint Consensus Statement of the American Academy of Sleep Medicine and Sleep Research Society. Sleep. 2015 Jun 1;38(6):843-4. doi: 10.5665/sleep.4716. — View Citation

Wilmot KA, O'Flaherty M, Capewell S, Ford ES, Vaccarino V. Coronary Heart Disease Mortality Declines in the United States From 1979 Through 2011: Evidence for Stagnation in Young Adults, Especially Women. Circulation. 2015 Sep 15;132(11):997-1002. doi: 10.1161/CIRCULATIONAHA.115.015293. Epub 2015 Aug 24. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hypertensive disorders of pregnancy	Gestational hypertension and preeclampsia, assessed through medical chart review	Through study completion for each participant, an average of 7.5 months after enrollment
Secondary	Gestational diabetes	Assessed through medical chart review	Through study completion for each participant, an average of 7.5 months after enrollment
Secondary	Preterm delivery	Defined as delivery <37 weeks gestation, assessed through medical chart review	At study completion for each participant (delivery), an average of 7.5 months after enrollment
Secondary	Low birth weight	Defined as birthweight<10th percentile for gestational age, assessed through medical chart review	At study completion for each participant (delivery), an average of 7.5 months after enrollment
Secondary	All adverse pregnancy outcomes (composite)	Composite measure including gestational hypertension, preeclampsia, gestational diabetes, preterm delivery, and low birth weight, assessed through medical chart review	Through study completion for each participant, an average of 7.5 months after enrollment
Secondary	Blood pressure	Assessed during the first trimester study visit and through medical chart review	Through study completion for each participant, an average of 7.5 months after enrollment
Secondary	Glycemic control	From glucose tolerance test, assessed through medical chart review	Through study completion for each participant, an average of 7.5 months after enrollment