Pregnancy Complications, Sedentary Behavior
Conditions
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
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).
Participants in the study will receive educational materials provided one time by email about the currently recommended physical activity during pregnancy.
Sponsors
Study design
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
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
| Measure | Time frame | Description |
|---|---|---|
| Sedentary Time | Randomization to study completion, about 6 months | objectively measured using activPAL3 micro |
| Standing | Randomization to study completion, about 6 months | Objectively measured using activPAL3 micro |
| Steps Per Day | Randomization to study completion, about 6 months | Objectively measured using activPAL3 micro |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment | Active recruitment phase, about 1 year | Participants screened for eligibility |
| Outcome Assessment Rates | Second 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 |
| Retention | Beginning of randomization to 2nd trimester and 3rd trimester | Number of randomized intervention and control participants remaining at each follow up timepoint |
| Intervention Adherence to Behavioral Coaching Contacts | Randomization to study completion, about 6 months | Percentage 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
| Arm | Count |
|---|---|
| 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 |
| Total | 51 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 6 | 0 |
| Overall Study | Physician Decision | 0 | 1 |
| Overall Study | Pregnancy loss | 1 | 1 |
Baseline characteristics
| Characteristic | Usual Care Control | Total | Sedentary Behavior Reduction Intervention |
|---|---|---|---|
| Age, Continuous | 32.5 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 Participants | 2 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 16 Participants | 49 Participants | 33 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 6 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) White | 17 Participants | 42 Participants | 25 Participants |
| Sedentary Time | 10.52 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 Participants | 51 Participants | 34 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 34 | 0 / 17 |
| other Total, other adverse events | 6 / 34 | 6 / 17 |
| serious Total, serious adverse events | 0 / 34 | 1 / 17 |
Outcome results
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sedentary Behavior Reduction Intervention | Sedentary Time | Baseline Sedentary Time | 10.42 total hours/day | Standard Deviation 0.28 |
| Sedentary Behavior Reduction Intervention | Sedentary Time | Follow-Up Sedentary Time | 9.62 total hours/day | Standard Deviation 0.29 |
| Usual Care Control | Sedentary Time | Baseline Sedentary Time | 10.52 total hours/day | Standard Deviation 0.4 |
| Usual Care Control | Sedentary Time | Follow-Up Sedentary Time | 10.38 total hours/day | Standard Deviation 0.34 |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sedentary Behavior Reduction Intervention | Standing | Baseline Standing | 2.79 hours/day | Standard Deviation 0.2 |
| Sedentary Behavior Reduction Intervention | Standing | Follow-Up Standing | 3.81 hours/day | Standard Deviation 0.26 |
| Usual Care Control | Standing | Baseline Standing | 2.74 hours/day | Standard Deviation 0.29 |
| Usual Care Control | Standing | Follow-Up Standing | 2.81 hours/day | Standard Deviation 0.31 |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sedentary Behavior Reduction Intervention | Steps Per Day | Baseline Steps per day | 5224 steps per day | Standard Deviation 502 |
| Sedentary Behavior Reduction Intervention | Steps Per Day | Follow-Up Steps per day | 6777 steps per day | Standard Deviation 656 |
| Usual Care Control | Steps Per Day | Baseline Steps per day | 6268 steps per day | Standard Deviation 895 |
| Usual Care Control | Steps Per Day | Follow-Up Steps per day | 6479 steps per day | Standard Deviation 919 |
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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Sedentary Behavior Reduction Intervention | Intervention Adherence to Behavioral Coaching Contacts | 85.5 percentage of contacts |
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sedentary Behavior Reduction Intervention | Outcome Assessment Rates | 2nd Trimester | 30 Participants |
| Sedentary Behavior Reduction Intervention | Outcome Assessment Rates | 3rd Trimester | 27 Participants |
| Usual Care Control | Outcome Assessment Rates | 2nd Trimester | 16 Participants |
| Usual Care Control | Outcome Assessment Rates | 3rd Trimester | 15 Participants |
Recruitment
Participants screened for eligibility
Time frame: Active recruitment phase, about 1 year
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sedentary Behavior Reduction Intervention | Recruitment | Pitt+Me Research Registry | 69 Participants |
| Sedentary Behavior Reduction Intervention | Recruitment | Maternal Fetal Medicine Patient Referral | 38 Participants |
| Sedentary Behavior Reduction Intervention | Recruitment | E-mail Advertisements to Pitt Community | 27 Participants |
| Sedentary Behavior Reduction Intervention | Recruitment | Other (personal referrals, internet searches, and flyers) | 6 Participants |
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sedentary Behavior Reduction Intervention | Retention | 2nd Trimester Follow Up | 30 Participants |
| Sedentary Behavior Reduction Intervention | Retention | 3rd Trimester Follow Up | 27 Participants |
| Usual Care Control | Retention | 2nd Trimester Follow Up | 16 Participants |
| Usual Care Control | Retention | 3rd Trimester Follow Up | 15 Participants |