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Sedentary Behavior Reduction in Pregnancy Intervention Study

Sedentary Behavior Reduction in Pregnancy Intervention Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05093842
Acronym
SPRING
Enrollment
51
Registered
2021-10-26
Start date
2021-10-04
Completion date
2023-06-30
Last updated
2025-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy Complications, Sedentary Behavior

Keywords

Behavioral Intervention, Randomized Clinical Trial, Pregnancy

Brief 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. 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.

Interventions

BEHAVIORALSedentary Behavior Reduction

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).

BEHAVIORALInformation on Physical Activity Recommendations during Pregnancy

Participants in the study will receive educational materials provided one time by email about the currently recommended physical activity during pregnancy.

Sponsors

American Heart Association
CollaboratorOTHER
University of Pittsburgh
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Masking description

Research personnel conducting outcome assessments will be blinded to participant group assignment. As the participant will be receiving a behavioral intervention, both the participant and interventionist will be aware of group assignment.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

Inclusion criteria

* \<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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Sedentary TimeRandomization to study completion, about 6 monthsobjectively measured using activPAL3 micro
StandingRandomization to study completion, about 6 monthsObjectively measured using activPAL3 micro
Steps Per DayRandomization to study completion, about 6 monthsObjectively measured using activPAL3 micro

Secondary

MeasureTime frameDescription
RecruitmentActive recruitment phase, about 1 yearParticipants screened for eligibility
Outcome Assessment RatesSecond and third trimester visit. Two participants were removed from this analysis due to miscarriage after randomization.Number of participants that have complete objective sedentary time and other outcome data
RetentionBeginning of randomization to 2nd trimester and 3rd trimesterNumber of randomized intervention and control participants remaining at each follow up timepoint
Intervention Adherence to Behavioral Coaching ContactsRandomization to study completion, about 6 monthsPercentage of intervention contacts completed. This includes behavioral lessons and check-ins.

Countries

United States

Participant flow

Recruitment details

SPRING is a pilot and feasibility randomized clinical trial conducted in the greater Pittsburgh, PA (United States) area between October 2021 and June 2023.

Pre-assignment details

A total of 51 first trimester pregnant individuals at risk for high sedentary behavior and adverse pregnancy outcomes (APO) were randomized 2:1 to a multi-component sedentary behavior reduction intervention or no-contact control.

Participants by arm

ArmCount
Sedentary Behavior Reduction Intervention
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. Sedentary Behavior Reduction: 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 Pregnancy: Participants in the study will receive educational materials provided one time by email about the currently recommended physical activity during pregnancy.
34
Usual Care Control
Printable information on physical activity recommendations only Information on Physical Activity Recommendations during Pregnancy: Participants in the study will receive educational materials provided one time by email about the currently recommended physical activity during pregnancy.
17
Total51

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up60
Overall StudyPhysician Decision01
Overall StudyPregnancy loss11

Baseline characteristics

CharacteristicUsual Care ControlTotalSedentary Behavior Reduction Intervention
Age, Continuous32.5 years
STANDARD_DEVIATION 3.6
32.1 years
STANDARD_DEVIATION 4.15
31.7 years
STANDARD_DEVIATION 4.7
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants2 Participants1 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
16 Participants49 Participants33 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants6 Participants6 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants3 Participants3 Participants
Race (NIH/OMB)
White
17 Participants42 Participants25 Participants
Sedentary Time10.52 hours/day
STANDARD_DEVIATION 0.4
10.47 hours/day
STANDARD_DEVIATION 0.34
10.42 hours/day
STANDARD_DEVIATION 0.28
Sex: Female, Male
Female
17 Participants51 Participants34 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 340 / 17
other
Total, other adverse events
6 / 346 / 17
serious
Total, serious adverse events
0 / 341 / 17

Outcome results

Primary

Sedentary Time

objectively measured using activPAL3 micro

Time frame: Randomization to study completion, about 6 months

Population: Two participants were removed from this analysis due to miscarriage after randomization.

ArmMeasureGroupValue (MEAN)Dispersion
Sedentary Behavior Reduction InterventionSedentary TimeBaseline Sedentary Time10.42 total hours/dayStandard Deviation 0.28
Sedentary Behavior Reduction InterventionSedentary TimeFollow-Up Sedentary Time9.62 total hours/dayStandard Deviation 0.29
Usual Care ControlSedentary TimeBaseline Sedentary Time10.52 total hours/dayStandard Deviation 0.4
Usual Care ControlSedentary TimeFollow-Up Sedentary Time10.38 total hours/dayStandard Deviation 0.34
p-value: <0.05Mixed Models Analysis
Primary

Standing

Objectively measured using activPAL3 micro

Time frame: Randomization to study completion, about 6 months

Population: Two participants were removed from this analysis due to miscarriage after randomization.

ArmMeasureGroupValue (MEAN)Dispersion
Sedentary Behavior Reduction InterventionStandingBaseline Standing2.79 hours/dayStandard Deviation 0.2
Sedentary Behavior Reduction InterventionStandingFollow-Up Standing3.81 hours/dayStandard Deviation 0.26
Usual Care ControlStandingBaseline Standing2.74 hours/dayStandard Deviation 0.29
Usual Care ControlStandingFollow-Up Standing2.81 hours/dayStandard Deviation 0.31
p-value: <0.05Mixed Models Analysis
Primary

Steps Per Day

Objectively measured using activPAL3 micro

Time frame: Randomization to study completion, about 6 months

Population: Two participants were removed from this analysis due to miscarriage after randomization.

ArmMeasureGroupValue (MEAN)Dispersion
Sedentary Behavior Reduction InterventionSteps Per DayBaseline Steps per day5224 steps per dayStandard Deviation 502
Sedentary Behavior Reduction InterventionSteps Per DayFollow-Up Steps per day6777 steps per dayStandard Deviation 656
Usual Care ControlSteps Per DayBaseline Steps per day6268 steps per dayStandard Deviation 895
Usual Care ControlSteps Per DayFollow-Up Steps per day6479 steps per dayStandard Deviation 919
p-value: <0.05Mixed Models Analysis
Secondary

Intervention Adherence to Behavioral Coaching Contacts

Percentage of intervention contacts completed. This includes behavioral lessons and check-ins.

Time frame: Randomization to study completion, about 6 months

Population: Initially, there were 34 Intervention participants. One participant was removed from this Intention To Treat analysis due to miscarriage after randomization.

ArmMeasureValue (MEAN)
Sedentary Behavior Reduction InterventionIntervention Adherence to Behavioral Coaching Contacts85.5 percentage of contacts
Secondary

Outcome Assessment Rates

Number of participants that have complete objective sedentary time and other outcome data

Time frame: Second and third trimester visit. Two participants were removed from this analysis due to miscarriage after randomization.

Population: Randomized participants with single gestation pregnancy

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Sedentary Behavior Reduction InterventionOutcome Assessment Rates2nd Trimester30 Participants
Sedentary Behavior Reduction InterventionOutcome Assessment Rates3rd Trimester27 Participants
Usual Care ControlOutcome Assessment Rates2nd Trimester16 Participants
Usual Care ControlOutcome Assessment Rates3rd Trimester15 Participants
Secondary

Recruitment

Participants screened for eligibility

Time frame: Active recruitment phase, about 1 year

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Sedentary Behavior Reduction InterventionRecruitmentPitt+Me Research Registry69 Participants
Sedentary Behavior Reduction InterventionRecruitmentMaternal Fetal Medicine Patient Referral38 Participants
Sedentary Behavior Reduction InterventionRecruitmentE-mail Advertisements to Pitt Community27 Participants
Sedentary Behavior Reduction InterventionRecruitmentOther (personal referrals, internet searches, and flyers)6 Participants
Secondary

Retention

Number of randomized intervention and control participants remaining at each follow up timepoint

Time frame: Beginning of randomization to 2nd trimester and 3rd trimester

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Sedentary Behavior Reduction InterventionRetention2nd Trimester Follow Up30 Participants
Sedentary Behavior Reduction InterventionRetention3rd Trimester Follow Up27 Participants
Usual Care ControlRetention2nd Trimester Follow Up16 Participants
Usual Care ControlRetention3rd Trimester Follow Up15 Participants

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026