Pregnancy ComplicationsSPRINGNCT05093842
Sedentary Behavior Reduction in Pregnancy Intervention Study
A study testing Sedentary Behavior Reduction and Information on Physical Activity Recommendations during Pregnancy in people with Pregnancy Complications and Sedentary Behavior, run by University of Pittsburgh at 1 site in United States.
Trial summary
This pilot and feasibility study will enroll newly pregnant women at risk for high sedentary behavior (SED) and elevated APO risk (n=53) and will randomize them to either a SED reduction intervention or control. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Pregnancy Complications, Sedentary Behavior
- What is being tested?
- Sedentary Behavior Reduction and Information on Physical Activity Recommendations during Pregnancy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Oct 2021to 30 Jun 2023
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult
Who may be able to join
- <13 w 0 d pregnant
- at risk for high levels of sedentary behavior: i) work at a desk job ≥ 30 hrs per week; ii) work at a desk job <30 hrs per week and report sitting on non-work days 1/2 the time or more; iii) do not work but report sitting 3/4 of the time or more; iv) self-reports <6000 steps per day
- ≥1 risk factor for APO: nulliparity, history of APO, prepregnancy BMI ≥ 30 kg/m2, or age ≥35 yr
- plan to deliver at UPMC facility or willing to provide medical record release for prenatal care and birth records
Who cannot join
- chronic hypertension (resting blood pressure ≥140/90 mmHg or antihypertensive medication use)
- pre-gestational diabetes
- self-report of inability to walk 2 blocks or climb a flight of stairs
- other serious medical condition in pregnancy for which exercise is contraindicated (e.g., underlying cardiac disease, severe anemia, chronic bronchitis, or poorly controlled hyperthyroidism or seizure disorder)
- unable to provide physician's consent to participate
- participating in another health-related intervention study that could affect study outcomes
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh, Department of Health and Human Development, 32 Oak Hill Court, Room 220
Pittsburgh, Pennsylvania, 15261
About this study
This pilot and feasibility study will enroll newly pregnant women at risk for high sedentary behavior (SED) and elevated APO risk (n=53) and will randomize them to either a SED reduction intervention or control. Research aims include to: 1) demonstrate our ability to decrease SED and increase standing and light activity in pregnant women; 2) evaluate feasibility; and 3) gather preliminary effects on clinical outcomes including APOs, cardiometabolic risk factors, well-being, and fetal outcomes.
Read the detailed description
Cardiovascular disease (CVD) accounts for 1 in 4 deaths among women of reproductive age. Decreasing adverse pregnancy outcomes (APO), e.g. hypertensive disorders of pregnancy, gestational diabetes, and preterm birth, could reduce this burden. APOs have serious immediate health consequences and are recognized by the AHA as major risk factors for future CVD. Yet, APOs are hard to prevent and treat, with a 20% prevalence that is increasing in the U.S. Moderate-vigorous intensity physical activity (MVPA) reduces APOs, but less than 1 in 4 pregnant women achieve guidelines and pregnant women report unique barriers such as fatigue, pain, medical restriction, and concern for the baby.
Sitting, or 'sedentary behavior' (SED) is a novel risk factor for CVD. Yet, sparse research and no U.S. guidelines exist for SED in pregnancy. Our recent AHA-funded cohort study in pregnant women (n=120) objectively measured SED and MVPA during each trimester. While MVPA was not related to outcomes, pregnant women with high vs. low SED across pregnancy had greater odds of APO and gave birth to babies at a reduced gestational age. Considering that decreasing SED may be more feasible given the barriers to MVPA, the investigators hypothesize that a SED reduction intervention may be especially promising for reducing APOs and improving cardiovascular health for women and their children.
Given the dearth of SED research, trials, or guidelines for pregnant women, the investigators propose to use our preliminary data on behavioral targets, correlates, and determinants of SED during pregnancy to adapt our previously successful SED reduction interventions. This pilot and feasibility study will enroll newly pregnant women with high SED and elevated APO risk (n=53) and randomize them to either a SED reduction intervention or control (2:1 ratio). Research aims include to: 1) demonstrate our ability to decrease SED and increase standing and light activity in pregnant women; 2) evaluate feasibility; and 3) gather preliminary effects on clinical outcomes including APOs, cardiometabolic risk factors, well-being, and fetal outcomes.
Participants will complete three assessment visits, one in each trimester, including 1-week monitoring of SED and activity patterns with a thigh-worn activPAL and blood pressure measurement using a standard protocol. Other outcomes will be assessed by self-report and medical record review after the participant gives birth. Participants randomized to the intervention arm will be provided with a fitbit, a sit-stand desk attachment, and will complete virtual health coaching visits every two weeks throughout pregnancy to facilitate reduced SED, increase standing, and increased stepping throughout the day.
- Conditions
- Pregnancy Complications, Sedentary Behavior
- Being tested
- Sedentary Behavior Reduction, Information on Physical Activity Recommendations during Pregnancy
- Keywords
- Behavioral Intervention, Randomized Clinical Trial, Pregnancy
- Medical subject headings
- Pregnancy Complications, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sedentary Behavior ReductionBehavioural
Participants receive bimonthly behavioral health coaching, a sit-stand desk attachment or table, and an activity prompter if they do not already have one (e.g., fitbit, as needed).
Information on Physical Activity Recommendations during PregnancyBehavioural
Participants in the study will receive educational materials provided one time by email about the currently recommended physical activity during pregnancy.
| Study group | Role | What they receive |
|---|---|---|
| Sedentary Behavior Reduction Intervention | Experimental | Biweekly virtual health coaching, height-adjustable work station, and fitbit - targetting decreasing sedentary behavior, increasing standing, and increasing steps per day. Printable information on physical activity recommendations also provided. Receives: Behavioral: Sedentary Behavior Reduction; Behavioral: Information on Physical Activity Recommendations during Pregnancy |
| Usual Care Control | Active comparator | Printable information on physical activity recommendations only Receives: Behavioral: Information on Physical Activity Recommendations during Pregnancy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sedentary Time
objectively measured using activPAL3 micro
Measured: Randomization to study completion, about 6 months
Standing
Objectively measured using activPAL3 micro
Measured: Randomization to study completion, about 6 months
Steps Per Day
Objectively measured using activPAL3 micro
Measured: Randomization to study completion, about 6 months
Secondary outcomes (4)
Recruitment
Participants screened for eligibility
Measured: Active recruitment phase, about 1 year
Retention
Number of randomized intervention and control participants remaining at each follow up timepoint
Measured: Beginning of randomization to 2nd trimester and 3rd trimester
Intervention Adherence to Behavioral Coaching Contacts
Percentage of intervention contacts completed. This includes behavioral lessons and check-ins.
Measured: Randomization to study completion, about 6 months
Outcome Assessment Rates
Number of participants that have complete objective sedentary time and other outcome data
Measured: Second and third trimester visit. Two participants were removed from this analysis due to miscarriage after randomization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2021
- Study start4 Oct 2021
- Primary completion30 Mar 2023
- Study completion30 Jun 2023
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 (2)Papers the sponsor has linked to this study.
- Other trials for Pregnancy ComplicationsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 51 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 B Gibbs, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05093842
- Sponsor's protocol ID
- STUDY20110193
- Other IDs
- AHA 20TPA35490099
- Acronym
- SPRING
- Status last verified
- Dec 2024
- First submitted
- 23 Sep 2021
- Last updated
- 31 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators do not have plans to share data at this time and will not be collecting biospecimens as part of this protocol. In the future, reasonable requests for de-identified data from other scientists will be considered. Such data will be shared with approval by the Study PI and other investigators, as appropriate.
Publications
Gibbs BB, Kozai AC, McAdoo SN, Davis KD, Savidge MB, Paley JL, Hauspurg A, Catov JM. The sedentary behavior reduction in pregnancy intervention (SPRING) pilot and feasibility randomized trial. BMC Pregnancy Childbirth. 2024 Apr 11;24(1):261. doi: 10.1186/s12884-024-06474-3.
PubMed 38605328Barone Gibbs B, Kozai AC, McAdoo SN, Bastyr MC, Davis KD, Hauspurg A, Catov JM. Rationale, Design, and Methods for the Sedentary Behavior Reduction in Pregnancy Intervention (SPRING): Protocol for a Pilot and Feasibility Randomized Controlled Trial. JMIR Res Protoc. 2023 Jun 14;12:e48228. doi: 10.2196/48228.
PubMed 37314845
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sedentary Behavior Reduction in Pregnancy Intervention Study
- ClinicalTrials.gov ID
- NCT05093842
- Acronym / sponsor ID
- SPRING / STUDY20110193
- Conditions
- Pregnancy Complications, Sedentary Behavior
- Keywords
- Behavioral Intervention, Randomized Clinical Trial, Pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- 4 Oct 2021 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 26 Oct 2021 (actual)
- Results
- Posted 31 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot and feasibility study will enroll newly pregnant women at risk for high sedentary behavior (SED) and elevated APO risk (n=53) and will randomize them to either a SED reduction intervention or control. Research aims include to: 1) demonstrate our ability to decrease SED and increase standing and light activity in pregnant women; 2) evaluate feasibility; and 3) gather preliminary effects on clinical outcomes including APOs, cardiometabolic risk factors, well-being, and fetal outcomes.
Detailed description
Cardiovascular disease (CVD) accounts for 1 in 4 deaths among women of reproductive age. Decreasing adverse pregnancy outcomes (APO), e.g. hypertensive disorders of pregnancy, gestational diabetes, and preterm birth, could reduce this burden. APOs have serious immediate health consequences and are recognized by the AHA as major risk factors for future CVD. Yet, APOs are hard to prevent and treat, with a 20% prevalence that is increasing in the U.S. Moderate-vigorous intensity physical activity (MVPA) reduces APOs, but less than 1 in 4 pregnant women achieve guidelines and pregnant women report unique barriers such as fatigue, pain, medical restriction, and concern for the baby.
Sitting, or 'sedentary behavior' (SED) is a novel risk factor for CVD. Yet, sparse research and no U.S. guidelines exist for SED in pregnancy. Our recent AHA-funded cohort study in pregnant women (n=120) objectively measured SED and MVPA during each trimester. While MVPA was not related to outcomes, pregnant women with high vs. low SED across pregnancy had greater odds of APO and gave birth to babies at a reduced gestational age. Considering that decreasing SED may be more feasible given the barriers to MVPA, the investigators hypothesize that a SED reduction intervention may be especially promising for reducing APOs and improving cardiovascular health for women and their children.
Given the dearth of SED research, trials, or guidelines for pregnant women, the investigators propose to use our preliminary data on behavioral targets, correlates, and determinants of SED during pregnancy to adapt our previously successful SED reduction interventions. This pilot and feasibility study will enroll newly pregnant women with high SED and elevated APO risk (n=53) and randomize them to either a SED reduction intervention or control (2:1 ratio). Research aims include to: 1) demonstrate our ability to decrease SED and increase standing and light activity in pregnant women; 2) evaluate feasibility; and 3) gather preliminary effects on clinical outcomes including APOs, cardiometabolic risk factors, well-being, and fetal outcomes.
Participants will complete three assessment visits, one in each trimester, including 1-week monitoring of SED and activity patterns with a thigh-worn activPAL and blood pressure measurement using a standard protocol. Other outcomes will be assessed by self-report and medical record review after the participant gives birth. Participants randomized to the intervention arm will be provided with a fitbit, a sit-stand desk attachment, and will complete virtual health coaching visits every two weeks throughout pregnancy to facilitate reduced SED, increase standing, and increased stepping throughout the day.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sedentary Behavior Reduction Intervention | Experimental | Behavioral: Sedentary Behavior Reduction, Behavioral: Information on Physical Activity Recommendations during PregnancyBiweekly virtual health coaching, height-adjustable work station, and fitbit - targetting decreasing sedentary behavior, increasing standing, and increasing steps per day. Printable information on physical activity recommendations also provided. |
| Usual Care Control | Active comparator | Behavioral: Information on Physical Activity Recommendations during PregnancyPrintable information on physical activity recommendations only |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- <13 w 0 d pregnant
- at risk for high levels of sedentary behavior: i) work at a desk job ≥ 30 hrs per week; ii) work at a desk job <30 hrs per week and report sitting on non-work days 1/2 the time or more; iii) do not work but report sitting 3/4 of the time or more; iv) self-reports <6000 steps per day
- ≥1 risk factor for APO: nulliparity, history of APO, prepregnancy BMI ≥ 30 kg/m2, or age ≥35 yr
- plan to deliver at UPMC facility or willing to provide medical record release for prenatal care and birth records
Key exclusion criteria (6 listed)
- chronic hypertension (resting blood pressure ≥140/90 mmHg or antihypertensive medication use)
- pre-gestational diabetes
- self-report of inability to walk 2 blocks or climb a flight of stairs
- other serious medical condition in pregnancy for which exercise is contraindicated (e.g., underlying cardiac disease, severe anemia, chronic bronchitis, or poorly controlled hyperthyroidism or seizure disorder)
- unable to provide physician's consent to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sedentary Behavior ReductionParticipants receive bimonthly behavioral health coaching, a sit-stand desk attachment or table, and an activity prompter if they do not already have one (e.g., fitbit, as needed). | Behavioural | Sedentary Behavior Reduction Intervention |
| Information on Physical Activity Recommendations during PregnancyParticipants in the study will receive educational materials provided one time by email about the currently recommended physical activity during pregnancy. | Behavioural | Sedentary Behavior Reduction Intervention, Usual Care Control |
Primary outcome
Sedentary Time
Time frame: Randomization to study completion, about 6 months
objectively measured using activPAL3 micro
Standing
Time frame: Randomization to study completion, about 6 months
Objectively measured using activPAL3 micro
Steps Per Day
Time frame: Randomization to study completion, about 6 months
Objectively measured using activPAL3 micro
4 secondary outcomes
Recruitment
Time frame: Active recruitment phase, about 1 year
Retention
Time frame: Beginning of randomization to 2nd trimester and 3rd trimester
Intervention Adherence to Behavioral Coaching Contacts
Time frame: Randomization to study completion, about 6 months
Outcome Assessment Rates
Time frame: Second and third trimester visit. Two participants were removed from this analysis due to miscarriage after randomization.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38605328Gibbs BB, Kozai AC, McAdoo SN, Davis KD, Savidge MB, Paley JL, Hauspurg A, Catov JM. The sedentary behavior reduction in pregnancy intervention (SPRING) pilot and feasibility randomized trial. BMC Pregnancy Childbirth. 2024 Apr 11;24(1):261. doi: 10.1186/s12884-024-06474-3.
- Derived from this study: PubMed 37314845Barone Gibbs B, Kozai AC, McAdoo SN, Bastyr MC, Davis KD, Hauspurg A, Catov JM. Rationale, Design, and Methods for the Sedentary Behavior Reduction in Pregnancy Intervention (SPRING): Protocol for a Pilot and Feasibility Randomized Controlled Trial. JMIR Res Protoc. 2023 Jun 14;12:e48228. doi: 10.2196/48228.
- Individual participant dataSharing planned: No. The investigators do not have plans to share data at this time and will not be collecting biospecimens as part of this protocol. In the future, reasonable requests for de-identified data from other scientists will be considered. Such data will be shared with approval by the Study PI and other investigators, as appropriate.
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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 B Gibbs 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?
A study testing Sedentary Behavior Reduction and Information on Physical Activity Recommendations during Pregnancy in people with Pregnancy Complications and Sedentary Behavior, 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 4 inclusion and 6 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 31 Jan 2025. 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 31 Jan 2025). 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?
Sedentary Time (time frame: Randomization to study completion, about 6 months). The study lists 3 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 NCT05093842, which also lists 2 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 31 Jan 2025.