Sedentary Behavior Reduction in Pregnancy Intervention Study (SPRING)
Primary Purpose
Pregnancy Complications, Sedentary Behavior
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sedentary Behavior Reduction
Information on Physical Activity Recommendations during Pregnancy
Sponsored by
About this trial
This is an interventional prevention trial for Pregnancy Complications focused on measuring Behavioral Intervention, Randomized Clinical Trial, Pregnancy
Eligibility Criteria
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
Sites / Locations
- University of Pittsburgh, Department of Health and Human Development, 32 Oak Hill Court, Room 220
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Sedentary Behavior Reduction Intervention
Usual Care Control
Arm Description
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.
Printable information on physical activity recommendations only
Outcomes
Primary Outcome Measures
Sedentary time
objectively measured using activPAL3 micro
Secondary Outcome Measures
Recruitment
Participants screened, eligible, and randomized per month
Retention
Participants randomized that complete the trial
Intervention adherence to behavioral coaching contacts
Percentage of intervention contacts completed
Outcome assessment rates
Number of participants that have complete objective sedentary time and other outcome data
Full Information
NCT ID
NCT05093842
First Posted
September 23, 2021
Last Updated
July 5, 2023
Sponsor
University of Pittsburgh
Collaborators
American Heart Association
1. Study Identification
Unique Protocol Identification Number
NCT05093842
Brief Title
Sedentary Behavior Reduction in Pregnancy Intervention Study
Acronym
SPRING
Official Title
Sedentary Behavior Reduction in Pregnancy Intervention Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
October 4, 2021 (Actual)
Primary Completion Date
March 30, 2023 (Actual)
Study Completion Date
June 30, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
American Heart Association
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy Complications, Sedentary Behavior
Keywords
Behavioral Intervention, Randomized Clinical Trial, Pregnancy
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
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.
Allocation
Randomized
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sedentary Behavior Reduction Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care Control
Arm Type
Active Comparator
Arm Description
Printable information on physical activity recommendations only
Intervention Type
Behavioral
Intervention Name(s)
Sedentary Behavior Reduction
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Information on Physical Activity Recommendations during Pregnancy
Intervention Description
Participants in the study will receive educational materials provided one time by email about the currently recommended physical activity during pregnancy.
Primary Outcome Measure Information:
Title
Sedentary time
Description
objectively measured using activPAL3 micro
Time Frame
Randomization to study completion, about 6 months
Secondary Outcome Measure Information:
Title
Recruitment
Description
Participants screened, eligible, and randomized per month
Time Frame
Active recruitment phase, about 1 year
Title
Retention
Description
Participants randomized that complete the trial
Time Frame
Beginning of randomization to trial completion, about 1.5 years
Title
Intervention adherence to behavioral coaching contacts
Description
Percentage of intervention contacts completed
Time Frame
Randomization to study completion, about 6 months
Title
Outcome assessment rates
Description
Number of participants that have complete objective sedentary time and other outcome data
Time Frame
Beginning of randomization to trial completion, about 1.5 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bethany B Gibbs
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh, Department of Health and Human Development, 32 Oak Hill Court, Room 220
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15261
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
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.
Learn more about this trial
Sedentary Behavior Reduction in Pregnancy Intervention Study
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