Sedentary Behavior Reduction in Pregnancy Intervention Study
Phase: NA
Conditions: Pregnancy Complications, Sedentary Behavior
Sponsor: University of Pittsburgh

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Study Protocol 
 
 
 
 
 
 
Official Title: 
Rationale, Design, and Methods for the Sedentary Behavior Reduction in Pregnancy Intervention 
(SPRING): Protocol for a Pilot and Feasibility Randomized Controlled Trial 
 
 
 
 
ClinicalTrials.gov ID (NCT number):  
NCT05093842 
 
 
 
Protocol Date:  
April 16, 2023 
 
 
 
 
 
 
 
 
 
 
 
 

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Scientific Background 
 
Cardiovascular disease (CVD) remains the number one health threat in women [1]. Adverse 
pregnancy outcomes (APOs), such as hypertensive disorders of pregnancy, gestational diabetes, 
and preterm birth, affect up to 20% of pregnant women and are recognized as major risk factors 
for latent and future CVD [2,3]. Though research to disentangle the contributions of 
prepregnancy risk factors from APOs on future CVD risk is ongoing, interventions that prevent 
APOs as a target for reducing CVD offer immediate and possibly long-term benefits. Effective 
preventative therapies, however, remain elusive [4]. Moderate to vigorous-intensity physical 
activity reduces APO risk [5,6], but less than 1 in 4 pregnant women achieve guidelines [7]. This 
likely reflects that pregnant women report unique exercise barriers such as fatigue, pain, medical 
restriction, and concern for the baby [8].Therefore, more feasible lifestyle strategies to prevent 
APOs are needed. 
 
One such strategy could be reducing sedentary behavior (SED), which is defined as low-intensity 
behavior that occurs in a seated, reclined, or lying posture [9]. Considering barriers to more 
intensive physical activity during pregnancy, replacing SED across the day with standing and 
light-intensity physical activities may be more achievable. Excessive SED has been related to an 
increased risk of CVD and mortality in general populations, even after accounting for moderate- 
to vigorous-intensity physical activity [10]. Though sparse data on SED during pregnancy exist, 
our laboratory recently completed a small cohort study among 120 pregnant women that 
objectively measured SED and physical activity during each trimester [11]. We found that, on 
average, pregnant women had approximately 9.5 hours per day of SED, which is higher than the 
general population [12]. Further, using trajectory analysis, women with a pattern of very high 
SED across pregnancy (approximately 11 hours per day) versus low SED (approximately 8 hours 
per day) had 6.76 (95% CI 1.20-38.14) higher odds of experiencing an APO [11]. Of interest, 
women in the low and medium SED groups (approximately 8 and 9 hours per day, respectively) 
had no excess risk of APO, indicated a possible threshold effect. Similar threshold effects were 
observed for time spent standing and in the number of steps per day such that only women in the 
very low trajectory groups had excess risk. Importantly, moderate- to vigorous-intensity activity 
was not associated with APO outcomes, bolstering support for a strategy of reducing SED by 
increasing standing and daily steps as a novel intervention target to improve pregnancy health. 
Yet, few randomized clinical trials (RCTs) testing SED reduction interventions are available, 
especially in pregnant women. 
 
The Sedentary Behavior Reduction in Pregnancy Intervention (SPRING) pilot and feasibility 
study, funded by the American Heart Association (20TPA3549099), seeks to address these 
research gaps. SPRING is an RCT that tests the feasibility, acceptability, and preliminary effects 
of a novel intervention designed to reduce SED and improve all-day activity patterns among 
pregnant women at high risk for APOs. 
 
Study Objectives 
 
The SPRING study’s specific aims are to (1) evaluate the effect of SPRING versus control on 
objectively measured SED (primary outcome, hypothesized to decrease), standing (hypothesized 

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to increase), and steps per day (hypothesized to increase); (2) evaluate the feasibility and 
acceptability of SPRING, including recruitment, retention, outcome assessment rates, 
intervention fidelity, and program evaluation; and (3) estimate the preliminary effects of 
SPRING versus control on maternal-fetal health outcomes including composite APOs 
(hypertensive disorders of pregnancy, gestational diabetes, and preterm birth), maternal blood 
pressure and glucose, psychosocial outcomes, gestational age at birth, and infant birth 
anthropometrics. 
 
Study Design & Methods 
 
Study Design Overview  
 
In the absence of established SED-reduction interventions or guidelines in pregnant women, a 
pilot and feasibility RCT among pregnant women with higher risk for SED and APOs was 
chosen as the first logical step to determine if the intervention could successfully reduce SED by 
increasing standing and steps per day across pregnancy (SPIRIT [Standard Protocol Items: 
Recommendations for Intervention Trials] checklist [13]. The SPRING pilot and feasibility trial 
is registered on ClincialTrials.gov (NCT05093842). 
 
Potential participants complete baseline assessments and begin the 1-week baseline activity 
monitoring protocol between 10 weeks 0 days (100 weeks) and 12 weeks 6 days (126 weeks) of 
gestation. Upon receipt of valid activity monitoring data with a completed time-use diary and 
clearance to participate from the participant’s prenatal care provider, pregnant women are 
randomized in a 2:1 ratio to either a multicomponent SED-reduction intervention or a usual care 
control group. Beginning at approximately 14 weeks of gestation, participants randomized to the 
intervention group begin the active intervention, which lasts through 38 weeks of gestation or 
until the participant gives birth, whichever occurs first. Participants randomized to the usual care 
control arm do not receive the intervention but are mailed a Fitbit Luxe after giving birth. 
 
Participants in both groups complete assessments in each trimester and are remunerated US $40 
for completing the first trimester (baseline) assessment between 100 and 126 weeks, US $50 for 
completing the second-trimester assessment between 200 and 226 weeks of gestation, and US 
$60 for completing the third-trimester assessment between 320 and 346 weeks of gestation. After 
participants give birth, maternal-fetal outcomes are abstracted from medical records by trained 
clinical staff. 
 
All research procedures were approved by the University of Pittsburgh Human Research 
Protection Office (STUDY20110193). 
 
Recruitment and Screening 
 
Recruitment Methods Participants are recruited from within approximately 50 miles of the 
University of Pittsburgh’s main campus in Pittsburgh, Pennsylvania. A variety of recruitment 
methods are used, including the University of Pittsburgh Clinical and Translational Science 
Institute’s Pitt+Me research registry and targeted emails sent to the university community. In 
addition, recruitment messages from the study physician are sent to patients at the University of 

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Pittsburgh Medical Center’s (UPMC) Maternal Fetal Medicine clinic who meet eligibility 
requirements through the MyUPMC mobile app. Finally, flyers are placed in patient-facing areas 
of Magee-Womens Hospital of UPMC, the largest birthing hospital in the Pittsburgh region. 
 
Screening, Orientation, and Informed Consent 
 
Interested participants are directed to complete a web-based screening questionnaire using 
Research Electronic Data Capture (REDCap) [14,15]. The screening questionnaire contains a 
detailed summary of the study, a request for electronic consent to answer screening questions, 
and specific questions about the candidate’s current pregnancy, risk factors for APO, SED 
exposure and habits, chronic diseases, medications, and contact information. Trained study staff 
assess initial eligibility based on the answers to the screening questionnaire and, if a candidate is 
deemed ineligible, they are informed at that time. Candidates who appear to be eligible during 
initial screening are invited to a web-based videoconference orientation where the study is 
described in detail, verbal informed consent is obtained, and then an electronic informed consent 
document is signed by the participant and study personnel conducting the informed consent. 
Finally, a detailed medical and reproductive history questionnaire is administered to determine 
final eligibility. 
 
Randomization  
 
A randomization ratio of 2:1 (2 intervention to 1 control) was chosen to provide more robust data 
to evaluate the feasibility and acceptability of our intervention and assessment protocols [16]. To 
help achieve balance over time, blocks of 6 were selected, and 9 blocks of computer-generated, 
randomly ordered sets were placed sequentially into sealed, numbered envelopes by a blinded 
study personnel. These envelopes were then provided to the unblinded study personnel (principal 
investigator and interventionist) and kept in a secure location. 
 
Participant randomization begins with the blinded study coordinator notifying the principal 
investigator that a participant is eligible and has completed all baseline assessment procedures. 
The study investigator then opens the next sequential envelope and records the randomization 
assignment and date in the randomization log. The principal investigator then contacts the 
participant to inform her regarding her randomization assignment, describe next steps, ensure 
that the participant comprehends that the intervention and assessment study procedures are 
separate, and reinforce the importance of continued participation in either group. 
 
Outcome Assessments 
 
Study outcome assessments are conducted by trained, blinded study personnel and occur via 
web-based videoconference once per trimester of pregnancy. Any necessary assessment 
materials are mailed to participants prior to study visits. 
 
SED and physical activity are measured in each trimester. Objective assessment of activity 
patterns is conducted using a thigh-mounted activPAL3 monitor (PAL Technologies, Glasgow) 
worn for 24 hours over 8 days. This protocol is the best-practice methodology for field 
monitoring of SED and standing [17], and we have shown it to be a valid measure of moderate- 

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to vigorous-intensity physical activity in pregnant women [18]. Participants wear the monitor on 
the anterior upper thigh for 8 days, with removal only for swimming activities. Concurrently, 
participants are asked to record periods of work, nonwork, sleep, and nonwear in a diary for 
accurate data processing. Participants are verbally instructed regarding procedures for correct 
monitor wear at each virtual assessment visit, including visual verification of correct placement. 
Detailed written instructions on monitor wear and diary completion are also provided. The 
activPAL3 24-hour event data are downloaded and cleaned by removing periods of sleep and 
nonwear; remaining valid wear time is used to calculate average daily durations of time spent in 
SED (total and in prolonged bouts of at least 30 and 60 minutes), standing, and stepping. Daily 
frequency of steps and sit-stand transitions are also averaged across days. Lastly, to estimate 
moderate- to vigorous-intensity physical activity, time with a stepping frequency of at least 75 
steps per minute and 100 steps per minute are averaged across valid wear days from daily 
summary data. Averages are calculated overall and during working times (if applicable). Data 
are considered valid with at least 5 days of at least 10 hours of waking wear time recorded [19]. 
 
Self-reported SED and physical activity are assessed using the Pregnancy Physical Activity 
Questionnaire [20], with questions regarding proportion of time spent in SED during work and 
nonworking times added to improve the accuracy of self-reported SED assessment [21]. 
 
Blood pressure is assessed virtually during study assessment visits in each trimester using a 
validated oscillometric monitor [22]. Either a UA-611 monitor (A&D Medical) that was 
provided as part of prenatal care at the University of Pittsburgh Magee-Womens Hospital or a 
study-provided BP7250 monitor (Omron Healthcare Inc) is used. Participants use the same 
monitor and cuff for all visits. During the virtual assessment, participants first provide verbal 
confirmation of abstention from caffeine and nicotine for 1 hour prior. Then, participants place 
the cuff on the left upper arm and complete a supervised 5-minute quiet rest with their arm 
supported at chest level, back supported against a chair, and feet flat on the floor or other support 
with ankles and knees uncrossed. After the rest, the participant initiates the measurement by 
pressing the start button with the blood pressure monitor facing the video camera and visible 
only to the assessor (to reduce participant reactivity). The assessor leads the participant through 3 
measurements, taken with a 1-minute rest in between, and records blood pressures and heart rates 
in the database prior to informing the participant of all values. The average of the second and 
third measurements is used for analysis. 
 
Demographics, medical history, reproductive history, and medication use are collected at 
baseline using a standardized form. Anthropometry is assessed at baseline via self-reported 
height and pre-pregnancy weight, which are subsequently verified through medical record 
abstraction (described later). To capture changes that occurred following randomization, updates 
to demographics (eg, new employment) are reported in a questionnaire and changes to medical 
history or medication use (eg, a new diagnosis or starting, stopping, or changing dosage 
of medications) are assessed during an interval medical history review at each follow-up visit. 
 
Dietary intake is assessed at each visit using the Diet Screening Questionnaire, a 
semiquantitative questionnaire that measures typical dietary habits [23]. Psychosocial behavioral 
targets and outcomes are measured at baseline and each follow-up visit via web-based self-report 
questionnaires. Validated questionnaires assessing behavioral targets of the intervention include 

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the Sitting during Pregnancy Barriers and Outcome Expectations Questionnaire [24], Expected 
Outcomes and Barriers for Habitual Physical Activity [25], the Multidimensional Scale of 
Perceived Social Support [26], and Social Support for Exercise [27]. Validated questionnaires 
assessing possible psychosocial effects of the intervention include the Profile of Mood States 
[28], the Centers for Epidemiologic Studies Depression Scale (CES-D) [29], the Perceived Stress 
Scale [30], Health-Related Quality of Life for Nausea and Vomiting during Pregnancy [31], and 
the Pittsburgh Sleep Quality Index [32]. 
 
Adverse events are collected systematically at follow-up assessment visits by blinded study 
personnel. Details of new or worsening medical conditions, including pregnancy-related adverse 
events, are recorded and classified regarding severity and relationship. In addition, ongoing 
assessment of adverse events in the intervention group is conducted by intervention staff. All 
adverse events are reviewed by the principal investigator and, if needed, the study physician for 
accuracy, possible relationship to the intervention, and to make any necessary modifications or 
terminate participation in the intervention. 
 
Pregnancy health and maternal-fetal outcomes are abstracted from the participant’s medical 
record of prenatal visits and labor and delivery notes. Maternal outcomes extracted include 
gestational weight gain, clinic-measured blood pressures, pregnancy complications including 
APOs, glucose screening values, and tolerance tests (if available), and labor and delivery details. 
Fetal outcomes include gestational age at birth, anthropometrics, and complications. All 
abstractions are reviewed by a second reviewer and discrepancies are resolved. The study’s 
maternal-fetal medicine physician coinvestigator (AH) confirms all APOs and a random sample 
of healthy pregnancies for accuracy. 
 
Feasibility and Acceptability 
 
Feasibility and acceptability are also assessed through a variety of methods across the study 
period. Screening outcomes are recorded prospectively including recruitment sources and yield, 
eligibility rates and ineligibility reasons, and rates of enrollment. We also administer a study-
developed questionnaire at baseline (prior to randomization) to assess participant expectations, 
motivations, and experiences when enrolling in the SPRING RCT. Rates of valid assessment 
completion are also prospectively recorded. Intervention fidelity with respect to delivery, receipt, 
and enactment [33] is assessed at each intervention contact (see Intervention Content and 
Schedule section). A final web-based program evaluation assesses acceptability and includes 22 
short-answer, ranking, and multiple-choice questions. The evaluation is distributed after the last 
intervention lesson to intervention participants only and aims to evaluate participants’ 
perceptions regarding their health, usefulness of the intervention components, general 
satisfaction and acceptability of the intervention, and suggestions for improvement. 
 
Intervention  
 
Intervention Content and Schedule  
 
SPRING developed behavioral targets informed by the specific patterns of SED, standing, and 
daily steps that were associated with lower APO risk in our observation cohort of pregnant 

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women [11]. Specifically, we observed threshold effects whereby engaging in SED for 
approximately 9.2 hours per day or less, standing for approximately 3.8 hours per day or more, 
and accumulating approximately 7801 steps per day or more were the activity patterns associated 
with a significantly lower risk of an APO [11] along with other maternal and fetal health benefits 
[46-48]. We also considered additional data from our observational research regarding 
determinants, barriers, attitudes, and outcome expectations related to SED during pregnancy. 
Findings from these studies suggested that pregnancy-related physical symptoms such as nausea 
and fatigue along with work-related sitting were the most commonly reported barriers to 
reducing SED [24]. Using objectively measured SED data, we also found that desk jobs and 
fewer children aged 5 years or younger in the home emerged as the factors that are most strongly 
associated with SED during pregnancy [49]. We then used these data to adapt our existing SED-
reduction interventions in nonpregnant adults [50-52] to the new population of pregnant women 
at high risk for SED and APOs.  
 
Thus, with the overall goal of reducing SED to less than 9 hours per day, we set evidence-based 
behavioral targets for our intervention as follows: (1) increase standing time by 2-3 hours per day 
with a daily total target of at least 4 hours per day; (2) increase light-intensity movement across 
the day, achieving at least 7500 steps per day; and (3) increase steps by at least 250 per hour (up 
to 8 hours per day). To facilitate behavior change toward these standing and step targets in our 
intervention group, we developed an evidence- and theory-based, multicomponent intervention 
strategy across 3 levels of the socioecological model [34,35,37,40].  
 
Safety and fidelity of the intervention are assessed at each contact by measuring 
contraindications [36], delivery (provision of intervention components), receipt (self-report of 
intervention components working properly), and enactment (self-report of self-monitoring and 
goal achievement) [33]. 
 
Control Group 
 
Participants assigned to the control group are asked to continue their typical behavior for the 
duration of their pregnancy and are provided with a general handout regarding recommended 
physical activity during pregnancy [36] but received no further intervention materials. After 
delivery, control participants are mailed a report of their objective activity levels that were 
previously measured during the study assessments and a Fitbit Luxe. 
 
Eligibility Criteria  
 
We recruit participants in their first trimester of pregnancy who are at risk for high levels of SED 
and who have at least 1 risk factor for APO. These criteria reflect an early gestational age when 
we can intervene meaningfully across pregnancy and higher SED appropriate for modification 
(ie, reduction) to reach the levels that we have found to be associated with better pregnancy 
outcomes [11]. The criteria of having at least 1 risk factor for APO relate to our long-term goal 
to test whether our intervention can reduce APO risk; therefore, we sought to evaluate feasibility 
and preliminary effects in this specific population. Lastly, to allow for our exploratory outcome 
assessment using prenatal records of maternal-fetal outcomes, participants are required to 

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consent to abstraction either through our affiliation with the University of Pittsburgh Medical 
Center or through separate medical record release if they are receiving prenatal care elsewhere. 
 
Participants younger than 18 years or older than 45 years are excluded to avoid an inability to 
provide consent and more complicated pregnancies with advanced age, respectively. Those with 
preexisting hypertension or diabetes are excluded because existing management of these 
conditions could affect our study outcomes (eg, prenatal blood pressure and glucose test results). 
Any other contraindications to exercise during pregnancy or severe mobility limitation are also 
exclusionary since the intervention asks participants to increase standing and daily steps. We also 
require participants to receive clearance for participation in the intervention from their prenatal 
care provider as an additional safety precaution. Lastly, those participating in other interventional 
research that could confound our study outcomes are excluded to reduce bias or contamination. 
 
Inclusion/Exclusion Criteria  
 
Inclusion criteria  
 
Gestational age: 
o Between 10 weeks 0 days and 12 weeks 6 days of gestation 
 
At risk for high sedentary behavior (meets at least one of the following criteria): 
o Primarily sitting, full-time desk job (more than 30 hours per week) 
o Primarily sitting, part-time desk job (less than 30 hours per week) and reports sitting at 
least half of the time during nonwork days 
o Does not work and reports sitting at least three-fourths of the time 
o Reports no more than 6000 steps per day from a wearable activity monitor 
 
Risk factor for adverse pregnancy outcome (APO; meets one of the following criteria): 
o Nulliparity 
o History of APO 
o Pre-pregnancy BMI of 30 kg/m2 or greater 
o Age of 35 years or older 
 
Medical record access: 
o Plans to deliver at the University of Pittsburgh facility or willing to provide consent for 
medical record release of prenatal care and birth records 
 
Exclusion criteria  
 
Young or advanced maternal age: 
o Younger than 18 years; older than 45 years 
Chronic hypertension: 
o Resting blood pressure of 140/90 mm Hg or greater or antihypertensive medication use 
Pregestational diabetes: 
o Type 1 or type 2 diabetes, prior to pregnancy 
Contraindication to exercise: 

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o Serious medical conditions such as underlying cardiac disease, severe anemia, chronic 
bronchitis, poorly controlled hyperthyroidism, or seizure disorder 
Severe mobility limitation: 
o Self-report of inability to walk 2 blocks or climb a flight of stairs 
No prenatal care provider clearance: 
o Unable to obtain a signed permission form from a prenatal care provider to participate in 
the intervention 
Other research intervention: 
o Participating in another health-related intervention study that could affect study outcomes 
Travel plans restricting participation: 
o Plans to travel that limit ability to fully participate in the study protocol 
 
 
Statistical Considerations 
 
Analytic Strategy for Aim 1 and the Exploratory Aim 
 
We will use Stata (StataCorp) for all analyses with an intention-to-treat philosophy. First, 
participant flow will be summarized using a Consolidated Standards of Reporting Trials diagram 
for randomized trials [53]. Second, descriptive statistics will be computed for variables by 
treatment group and time point. Third, the baseline measures will be compared between the 2 
groups using independent samples t tests, Wilcoxon rank sum, chi-square, or Fisher exact tests, 
as appropriate. While significant differences are not expected, any found will be considered in 
sensitivity analyses. Next, main analyses will fit a series of linear mixed models with follow-up 
continuous outcomes as the dependent variable (eg, SED); intervention group (intervention or 
control), follow-up time (eg, second and third trimester), and group × time as fixed effects; 
baseline value of outcomes as fixed-effect covariates; and a participant random effect to account 
for multiple observations from the same participant over time. Mean contrasts will estimate the 
between-group difference at each follow-up time point. Similar methods will be used for the 
other activity variables (eg, standing and steps). Analysis of the exploratory aim will use similar 
methods, with logistic regression for dichotomous outcomes (eg, APOs). We will first consider 
the use of multiple imputation to account for missing data, but we will perform additional 
sensitivity or exploratory analyses to ensure robustness and extend our findings, for example, 
complete-data-only or last-value-carried forward strategies for missing data. 
 
Analytic Strategy Aim 2 
 
For the recruitment feasibility outcomes, we will calculate frequencies of recruitment method use 
and yields; rates of screening contacts, consent, eligibility, and randomization; reasons for 
ineligibility; and characteristics of enrolled participants. Benchmarks will be 42 (80%) for 
retention and 40 (95%) of the retained participants for valid outcome assessments. Intervention 
fidelity will be calculated based on intervention contacts with an overall average benchmark of 
30 (85%) of each intervention contact competed. Quantitative or semiquantitative acceptability 
and program evaluation data will be summarized descriptively. Open-ended questionnaires will 
be analyzed using a constant comparison method to identify salient categories, themes, and 

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patterns via open coding, iterative review and codebook generation, code linking into similar 
categories, and final integration into themes [54]. 
 
Sample Size Considerations 
 
The primary outcome of this study is a change in SED. Based on our pilot data that suggest 
lower SED protects women from APOs [11], we calculated sample size requirements assuming 
the following: a between-group SED difference of 1 hour (SD 56 minutes) per day, a 2:1 
randomization ratio to enhance recruitment and increase program evaluation and feasibility data, 
90% power, and α=.05. This yielded a required sample size of 42 (28 intervention and 14 
control). A final sample size of up to 53 (35 intervention and 18 control), inflated by 20%, was 
adopted to account for attrition. 
 
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