Pregnancy RelatedMoM HealthNCT03084302
Monitoring Movement and Health Study
An observational study of Pregnancy Related and Obesity, run by University of Pittsburgh at 1 site in United States.
Trial summary
The investigators will study sedentary behavior (SED) across pregnancy in young women. We hypothesize that SED will increase across pregnancy and that higher SED will be related to worse cardiovascular health, specifically elevated blood pressure (BP) and excessive gestational weight gain (GWG). Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Pregnancy Related, Obesity, Hypertension
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2017to 30 Jun 2020
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Adult
Study population: We will recruit 120 women in their first trimester of pregnancy. Women must be 18-45 and must be seeing a UPMC provider for their prenatal care and delivery.
Who may be able to join
- 8-12 weeks pregnant
- 18-45 years old
- plan to receive prenatal care and deliver with University of Pittsburgh Medical Center providers
Who cannot join
- use of medication to treat diabetes or hypertension
- medical condition that severely limits physical activity (e.g., cannot walk 2 blocks)
- other serious medical condition that could affect outcomes (such as systemic lupus, chronic renal disease, or hepatitis)
Trial locations and contacts
1 site in 1 country.
United States1 site
Physical Activity and Weight Management Research Center
Pittsburgh, Pennsylvania, 15261
About this study
Official title: Sedentary Behavior in Pregnancy and Cardiovascular Health: the Monitoring Movement and Health (MoM Health) Study
The investigators will study sedentary behavior (SED) across pregnancy in young women. We hypothesize that SED will increase across pregnancy and that higher SED will be related to worse cardiovascular health, specifically elevated blood pressure (BP) and excessive gestational weight gain (GWG). Pregnancy is a biologically relevant period during which CVD risk factors may develop or worsen, contributing to future CVD. Pregnant women also spend most of their day sedentary, which is defined as too much sitting as distinct from too little exercise. SED has emerged as a risk factor, independent from moderate-to-vigorous physical activity (e.g., exercise), for elevated BP, obesity, diabetes, CVD, and mortality in general populations, but there are no recommendations for SED during pregnancy and few studies evaluate SED across pregnancy. These few studies are limited by small sample size, lack of repeated measures across trimesters, suboptimal SED assessment methodology, and a failure to link with clinical outcomes (e.g., BP, GWG). The investigators will address these gaps in a prospective study that will measure SED in 130 pregnant women across three trimesters using state-of-the-art objective activity monitors capable of measuring min-by-min activity by both intensity and posture. We will also measure BP and GWG during each trimester and, further, will link to and abstract all prenatal clinic weights and BPs, glucose screening results, gestational diabetes, preeclampsia, and adverse birth outcomes. Lastly, with the long-term goal of identifying women at high risk of SED during pregnancy and designing effective interventions, the investigators will efficiently evaluate correlates and determinants of SED which have never been studied during pregnancy.
Read the detailed description
Objective: The investigators aim to conduct a prospective cohort study using state-of-the-art, noninvasive measurement of sedentary behavior in n=130 pregnant women during each trimester of their first pregnancy. We will link sedentary behavior to gestational weight gain, blood pressure, and potential determinants such as demographics, health conditions and behaviors, psychosocial factors, perceptions/beliefs, and the environment.
Specific Aims:
Aim 1: Objectively measure sedentary behavior across pregnancy trimesters Aim 2: Relate objectively-measured sedentary behavior to blood pressure and gestational weight gain across pregnancy Aim 3: Characterize correlates and determinants of sedentary behavior during pregnancy
1.3 Background: Cardiovacular disease (CVD) remains the leading cause of death in women with minimal declines over the past 30 years among women <55 years old. Stagnant rates of CVD mortality in younger women have occurred alongside notable declines in men and older adults and are thought to be due, in part, to high rates of obesity and elevated blood pressure (BP). Related to this, the American Heart Association (AHA) recently identified primordial prevention, a population-level approach that targets preventing rather than treating CVD risk factors, as a necessary strategy to reduce the CVD burden. To achieve primordial prevention, the target must be populations at risk for developing CVD risk factors (vs. those with existing risk factors), such as younger women.
Pregnancy is a biologically unique period for young women during which CVD risk factors such as obesity and high blood pressure (BP) can develop or worsen, contributing to future CVD. Pregnant women also spend most of their time in sedentary behavior (SED). SED is any behavior that occurs in a seated/reclining position with low energy expenditure and is now recognized as a behavior that is distinct from inactivity, or a lack of moderate-vigorous physical activity (MVPA). Though MVPA has known benefits, SED is an emerging, independent risk factor for obesity, CVD, and mortality. Importantly, prolonged bouts of SED (accumulated in bouts lasting 30 min or more) in non-pregnant persons are more strongly related to obesity and induce unfavorable hemodynamic responses, such as increased BP. We hypothesize that too much SED across pregnancy is an important contributor to excess gestational weight gain (GWG) and elevated BP, two important CVD risk factors in young women.
Remarkably, a dearth of studies evaluates SED across pregnancy. In cross-sectional studies, pregnant women spend 50-60% of their day in SED and SED is highest in the 3rd trimester. Yet, no study has evaluated if SED increases across pregnancy (repeated measurements) using best practice SED assessment methodology (objective device capable of capturing posture and intensity). Moreover, no study has evaluated whether greater SED is associated with increased GWG and BP in pregnant women, which in turn are known to impact pregnancy health and later maternal CVD risk. Current guidelines only advise MVPA for pregnant women with no recommendations about SED, highlighting the research gaps about SED and its consequences during pregnancy. Moreover, clarifying the role of SED in pregnancy is important because lowering SED might be a feasible strategy for pregnant women, who have low participation in9 and unique barriers to MVPA. Lastly, little is known about correlates and determinants of SED in pregnancy. Such data are critical for identifying women at risk for high SED during pregnancy and for developing effective interventions.
1.4 Significance: Sedentary behavior is a novel risk factor for weight gain, high BP, and CVD, yet patterns, correlates, determinants and consequences of sedentary behavior are poorly understood in pregnant women. Sedentary behavior is the most common behavior in pregnant women, but the dearth of research studies applying state-of-the-art sedentary behavior assessment methods and with repeated measures across pregnancy is a major research gap that we intend to address with this proposal. To the investigators' knowledge, no studies with optimal sedentary behavior measurement, assessing both posture and intensity while awake (i.e., activPAL), have been conducted in pregnant women. Beyond this, few studies have evaluated temporal trends in sedentary time across gestation. There is no research examining bouts of extended, uninterrupted sedentary time which have particularly deleterious effects on BP and are more strongly related to high BMI. Lastly, correlates and determinants of sedentary behavior are poorly understood overall and, in particular, among pregnant women. Before effective interventions can be designed to reduce sedentary behavior in pregnancy, nonmodifiable and modifiable factors associated with sedentary behavior must be better understood. Thus, the objective, longitudinal measurement of sedentary behavior in pregnancy proposed in this application will determine patterns, correlates, determinants, and consequences of sedentary behavior in pregnancy to move toward future goals of 1) clarifying risks and whether sedentary behavior recommendations are appropriate for pregnant women, 2) identifying groups at risk for high sedentary behavior, and 3) informing intervention targets. Further, this research addresses the AHA's mission to reduce the burden of CVD by investigating a novel strategy for primordial prevention of cardiovascular disease in young women.
- Conditions
- Pregnancy Related, Obesity, Hypertension
- Keywords
- sedentary behavior, physical activity
- Medical subject headings
- Obesity, Hypertension, Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women | Women in their first trimester of pregnancy, aged 18-45, who plan to receive their prenatal care from University of Pittsburgh Medical Center providers. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Classified as Having High Sedentary Behavior (by Trajectory)
Trajectories identified from objective data across trimesters. High sedentary behavior was defined as the highest group (~10.9 hr/day) based on growth mixture models from the objective data.
Measured: 1st, 2nd, and 3rd trimester of pregnancy
Number of Participants Classified as Having Low Moderate-to-vigorous Intensity Physical Activity (by Trajectory)
Low levels of physical activity across trimesters, identified by growth mixture modelling. The low trajectory corresponded to about 114 minutes per week or about 16 minutes per day.
Measured: 1st, 2nd, and 3rd trimester of pregnancy
Secondary outcomes (2)
Number of Participants With Excessive Gestational Weight Gain
from study visits and medical records excessive gestational weight gain was defined using 2009 Institute of Medicine Guidelines (reference: Institute of Medicine and National Research Council. Weight gain during pregnancy: reexamining the guidelines. Washington, DC: The National Academies Press; 2009)
Measured: at delivery
Adverse Pregnancy Outcomes
from study visits and medical records includes hypertensive disorders of pregnancy, preterm birth, intrauterine growth restrictions, gestational diabetes
Measured: during pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2017
- Study start1 Mar 2017
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Principal investigator, Bethany Barone Gibbs, University of Pittsburgh
- Investigators
- Bethany Barone Gibbs, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03084302
- Sponsor's protocol ID
- PRO16120430
- Acronym
- MoM Health
- Status last verified
- Oct 2022
- First submitted
- 7 Mar 2017
- Last updated
- 27 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data will be shared with secondary investigators after the following process. 1) Secondary investigators will submit a proposal to the principal investigator that will be reviewed by all Coinvestigators. 2) If all investigators approve, the secondary investigator will obtain institutional review board approval to conduct the proposed analyses, and 3) a deidentified dataset including only requested variables will be provided to the secondary researcher.
Publications
Barone Gibbs B, Paley JL, Jones MA, Whitaker KM, Connolly CP, Catov JM. Validity of self-reported and objectively measured sedentary behavior in pregnancy. BMC Pregnancy Childbirth. 2020 Feb 11;20(1):99. doi: 10.1186/s12884-020-2771-z.
PubMed 32046663Barone Gibbs B, Jones MA, Jakicic JM, Jeyabalan A, Whitaker KM, Catov JM. Objectively Measured Sedentary Behavior and Physical Activity Across 3 Trimesters of Pregnancy: The Monitoring Movement and Health Study. J Phys Act Health. 2021 Mar 1;18(3):254-261. doi: 10.1123/jpah.2020-0398. Epub 2021 Jan 28.
PubMed 33508775Jones MA, Catov JM, Jeyabalan A, Whitaker KM, Barone Gibbs B. Sedentary behaviour and physical activity across pregnancy and birth outcomes. Paediatr Perinat Epidemiol. 2021 May;35(3):341-349. doi: 10.1111/ppe.12731. Epub 2020 Oct 30.
PubMed 33124060Jones MA, Whitaker K, Wallace M, Barone Gibbs B. Demographic, Socioeconomic, and Health-Related Predictors of Objectively Measured Sedentary Time and Physical Activity During Pregnancy. J Phys Act Health. 2021 Jun 17;18(8):957-964. doi: 10.1123/jpah.2021-0097. Print 2021 Aug 1.
PubMed 34140419Whitaker KM, Zhang D, Kline CE, Catov J, Barone Gibbs B. Associations of Sleep With Sedentary Behavior and Physical Activity Patterns Across Pregnancy Trimesters. Womens Health Issues. 2021 Jul-Aug;31(4):366-375. doi: 10.1016/j.whi.2021.02.003. Epub 2021 Mar 11.
PubMed 33715925Paley JL, Jones MA, Catov JM, Whitaker KM, Kozai AC, Barone Gibbs B. Associations of Physical Activity and Sedentary Behaviors with Depressive Symptoms and Mood Disturbance Throughout Pregnancy. J Womens Health (Larchmt). 2024 Aug;33(8):1128-1138. doi: 10.1089/jwh.2023.0419. Epub 2024 Feb 6.
PubMed 38324012Gibbs BB, Jones MA, Whitaker KM, Ross ST, Davis KK. Measurement of Barriers, Attitudes, and Expectations for Sitting Less in Pregnancy. Am J Health Behav. 2021 Nov 15;45(6):956-970. doi: 10.5993/AJHB.45.6.1.
PubMed 34969408
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sedentary Behavior in Pregnancy and Cardiovascular Health: the Monitoring Movement and Health (MoM Health) Study
- ClinicalTrials.gov ID
- NCT03084302
- Acronym / sponsor ID
- MoM Health / PRO16120430
- Conditions
- Pregnancy Related, Obesity, Hypertension
- Keywords
- sedentary behavior, physical activity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 20 Mar 2017 (actual)
- Results
- Posted 16 Sep 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators will study sedentary behavior (SED) across pregnancy in young women. We hypothesize that SED will increase across pregnancy and that higher SED will be related to worse cardiovascular health, specifically elevated blood pressure (BP) and excessive gestational weight gain (GWG). Pregnancy is a biologically relevant period during which CVD risk factors may develop or worsen, contributing to future CVD. Pregnant women also spend most of their day sedentary, which is defined as too much sitting as distinct from too little exercise. SED has emerged as a risk factor, independent from moderate-to-vigorous physical activity (e.g., exercise), for elevated BP, obesity, diabetes, CVD, and mortality in general populations, but there are no recommendations for SED during pregnancy and few studies evaluate SED across pregnancy. These few studies are limited by small sample size, lack of repeated measures across trimesters, suboptimal SED assessment methodology, and a failure to link with clinical outcomes (e.g., BP, GWG). The investigators will address these gaps in a prospective study that will measure SED in 130 pregnant women across three trimesters using state-of-the-art objective activity monitors capable of measuring min-by-min activity by both intensity and posture. We will also measure BP and GWG during each trimester and, further, will link to and abstract all prenatal clinic weights and BPs, glucose screening results, gestational diabetes, preeclampsia, and adverse birth outcomes. Lastly, with the long-term goal of identifying women at high risk of SED during pregnancy and designing effective interventions, the investigators will efficiently evaluate correlates and determinants of SED which have never been studied during pregnancy.
Detailed description
Objective: The investigators aim to conduct a prospective cohort study using state-of-the-art, noninvasive measurement of sedentary behavior in n=130 pregnant women during each trimester of their first pregnancy. We will link sedentary behavior to gestational weight gain, blood pressure, and potential determinants such as demographics, health conditions and behaviors, psychosocial factors, perceptions/beliefs, and the environment.
Specific Aims:
Aim 1: Objectively measure sedentary behavior across pregnancy trimesters Aim 2: Relate objectively-measured sedentary behavior to blood pressure and gestational weight gain across pregnancy Aim 3: Characterize correlates and determinants of sedentary behavior during pregnancy
1.3 Background: Cardiovacular disease (CVD) remains the leading cause of death in women with minimal declines over the past 30 years among women <55 years old. Stagnant rates of CVD mortality in younger women have occurred alongside notable declines in men and older adults and are thought to be due, in part, to high rates of obesity and elevated blood pressure (BP). Related to this, the American Heart Association (AHA) recently identified primordial prevention, a population-level approach that targets preventing rather than treating CVD risk factors, as a necessary strategy to reduce the CVD burden. To achieve primordial prevention, the target must be populations at risk for developing CVD risk factors (vs. those with existing risk factors), such as younger women.
Pregnancy is a biologically unique period for young women during which CVD risk factors such as obesity and high blood pressure (BP) can develop or worsen, contributing to future CVD. Pregnant women also spend most of their time in sedentary behavior (SED). SED is any behavior that occurs in a seated/reclining position with low energy expenditure and is now recognized as a behavior that is distinct from inactivity, or a lack of moderate-vigorous physical activity (MVPA). Though MVPA has known benefits, SED is an emerging, independent risk factor for obesity, CVD, and mortality. Importantly, prolonged bouts of SED (accumulated in bouts lasting 30 min or more) in non-pregnant persons are more strongly related to obesity and induce unfavorable hemodynamic responses, such as increased BP. We hypothesize that too much SED across pregnancy is an important contributor to excess gestational weight gain (GWG) and elevated BP, two important CVD risk factors in young women.
Remarkably, a dearth of studies evaluates SED across pregnancy. In cross-sectional studies, pregnant women spend 50-60% of their day in SED and SED is highest in the 3rd trimester. Yet, no study has evaluated if SED increases across pregnancy (repeated measurements) using best practice SED assessment methodology (objective device capable of capturing posture and intensity). Moreover, no study has evaluated whether greater SED is associated with increased GWG and BP in pregnant women, which in turn are known to impact pregnancy health and later maternal CVD risk. Current guidelines only advise MVPA for pregnant women with no recommendations about SED, highlighting the research gaps about SED and its consequences during pregnancy. Moreover, clarifying the role of SED in pregnancy is important because lowering SED might be a feasible strategy for pregnant women, who have low participation in9 and unique barriers to MVPA. Lastly, little is known about correlates and determinants of SED in pregnancy. Such data are critical for identifying women at risk for high SED during pregnancy and for developing effective interventions.
1.4 Significance: Sedentary behavior is a novel risk factor for weight gain, high BP, and CVD, yet patterns, correlates, determinants and consequences of sedentary behavior are poorly understood in pregnant women. Sedentary behavior is the most common behavior in pregnant women, but the dearth of research studies applying state-of-the-art sedentary behavior assessment methods and with repeated measures across pregnancy is a major research gap that we intend to address with this proposal. To the investigators' knowledge, no studies with optimal sedentary behavior measurement, assessing both posture and intensity while awake (i.e., activPAL), have been conducted in pregnant women. Beyond this, few studies have evaluated temporal trends in sedentary time across gestation. There is no research examining bouts of extended, uninterrupted sedentary time which have particularly deleterious effects on BP and are more strongly related to high BMI. Lastly, correlates and determinants of sedentary behavior are poorly understood overall and, in particular, among pregnant women. Before effective interventions can be designed to reduce sedentary behavior in pregnancy, nonmodifiable and modifiable factors associated with sedentary behavior must be better understood. Thus, the objective, longitudinal measurement of sedentary behavior in pregnancy proposed in this application will determine patterns, correlates, determinants, and consequences of sedentary behavior in pregnancy to move toward future goals of 1) clarifying risks and whether sedentary behavior recommendations are appropriate for pregnant women, 2) identifying groups at risk for high sedentary behavior, and 3) informing intervention targets. Further, this research addresses the AHA's mission to reduce the burden of CVD by investigating a novel strategy for primordial prevention of cardiovascular disease in young women.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant women | – | –Women in their first trimester of pregnancy, aged 18-45, who plan to receive their prenatal care from University of Pittsburgh Medical Center providers. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- We will recruit 120 women in their first trimester of pregnancy. Women must be 18-45 and must be seeing a UPMC provider for their prenatal care and delivery.
Key inclusion criteria (3 listed)
- 8-12 weeks pregnant
- 18-45 years old
- plan to receive prenatal care and deliver with University of Pittsburgh Medical Center providers
Key exclusion criteria (3 listed)
- use of medication to treat diabetes or hypertension
- medical condition that severely limits physical activity (e.g., cannot walk 2 blocks)
- other serious medical condition that could affect outcomes (such as systemic lupus, chronic renal disease, or hepatitis)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Participants Classified as Having High Sedentary Behavior (by Trajectory)
Time frame: 1st, 2nd, and 3rd trimester of pregnancy
Trajectories identified from objective data across trimesters. High sedentary behavior was defined as the highest group (~10.9 hr/day) based on growth mixture models from the objective data.
Number of Participants Classified as Having Low Moderate-to-vigorous Intensity Physical Activity (by Trajectory)
Time frame: 1st, 2nd, and 3rd trimester of pregnancy
Low levels of physical activity across trimesters, identified by growth mixture modelling. The low trajectory corresponded to about 114 minutes per week or about 16 minutes per day.
2 secondary outcomes
Number of Participants With Excessive Gestational Weight Gain
Time frame: at delivery
Adverse Pregnancy Outcomes
Time frame: during pregnancy
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 32046663Barone Gibbs B, Paley JL, Jones MA, Whitaker KM, Connolly CP, Catov JM. Validity of self-reported and objectively measured sedentary behavior in pregnancy. BMC Pregnancy Childbirth. 2020 Feb 11;20(1):99. doi: 10.1186/s12884-020-2771-z.
- Results publication: PubMed 33508775Barone Gibbs B, Jones MA, Jakicic JM, Jeyabalan A, Whitaker KM, Catov JM. Objectively Measured Sedentary Behavior and Physical Activity Across 3 Trimesters of Pregnancy: The Monitoring Movement and Health Study. J Phys Act Health. 2021 Mar 1;18(3):254-261. doi: 10.1123/jpah.2020-0398. Epub 2021 Jan 28.
- Results publication: PubMed 33124060Jones MA, Catov JM, Jeyabalan A, Whitaker KM, Barone Gibbs B. Sedentary behaviour and physical activity across pregnancy and birth outcomes. Paediatr Perinat Epidemiol. 2021 May;35(3):341-349. doi: 10.1111/ppe.12731. Epub 2020 Oct 30.
- Results publication: PubMed 34140419Jones MA, Whitaker K, Wallace M, Barone Gibbs B. Demographic, Socioeconomic, and Health-Related Predictors of Objectively Measured Sedentary Time and Physical Activity During Pregnancy. J Phys Act Health. 2021 Jun 17;18(8):957-964. doi: 10.1123/jpah.2021-0097. Print 2021 Aug 1.
- Results publication: PubMed 33715925Whitaker KM, Zhang D, Kline CE, Catov J, Barone Gibbs B. Associations of Sleep With Sedentary Behavior and Physical Activity Patterns Across Pregnancy Trimesters. Womens Health Issues. 2021 Jul-Aug;31(4):366-375. doi: 10.1016/j.whi.2021.02.003. Epub 2021 Mar 11.
- Derived from this study: PubMed 38324012Paley JL, Jones MA, Catov JM, Whitaker KM, Kozai AC, Barone Gibbs B. Associations of Physical Activity and Sedentary Behaviors with Depressive Symptoms and Mood Disturbance Throughout Pregnancy. J Womens Health (Larchmt). 2024 Aug;33(8):1128-1138. doi: 10.1089/jwh.2023.0419. Epub 2024 Feb 6.
- Derived from this study: PubMed 34969408Gibbs BB, Jones MA, Whitaker KM, Ross ST, Davis KK. Measurement of Barriers, Attitudes, and Expectations for Sitting Less in Pregnancy. Am J Health Behav. 2021 Nov 15;45(6):956-970. doi: 10.5993/AJHB.45.6.1.
- Individual participant dataSharing planned: Yes. Individual participant data will be shared with secondary investigators after the following process. 1) Secondary investigators will submit a proposal to the principal investigator that will be reviewed by all Coinvestigators. 2) If all investigators approve, the secondary investigator will obtain institutional review board approval to conduct the proposed analyses, and 3) a deidentified dataset including only requested variables will be provided to the secondary researcher.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bethany Barone Gibbs, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy Related and Obesity, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Classified as Having High Sedentary Behavior (by Trajectory) (time frame: 1st, 2nd, and 3rd trimester of pregnancy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03084302, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2022.