Accepted for/Published in: JMIR Research Protocols
Date Submitted: Apr 16, 2023
Open Peer Review Period: Apr 16, 2023 - Apr 25, 2023
Date Accepted: Apr 30, 2023
(closed for review but you can still tweet)
Protocol for the Sedentary Behavior Reduction in Pregnancy Intervention (SPRING) Pilot and Feasibility Study: Rationale, Design, and Methods
ABSTRACT
Background:
Adverse pregnancy outcomes (APOs) identify cardiovascular disease risk, but few effective interventions are available. High sedentary behavior (SED) has recently been associated with APOs, but a dearth of randomized controlled trials (RCT) test SED reduction in pregnancy.
Objective:
The Sedentary Behavior Reduction in Pregnancy Intervention (SPRING) Pilot and Feasibility RCT addresses this gap by testing the feasibility, acceptability, and preliminary pregnancy health effects of an intervention to reduce SED in pregnant women. The objective of this manuscript is to describe the rationale and design of the SPRING Intervention.
Methods:
Pregnant participants (n=53) in their first trimester, who are at risk for high SED and APO and without contraindications, are randomized 2:1 to an intervention or control group. SED (primary outcome) and standing durations, and steps per day, are measured objectively in each trimester for one week with a thigh-mounted activPAL3 accelerometer. SPRING also seeks to demonstrate feasibility and acceptability while estimating preliminary effects on maternal-fetal health outcomes assessed during study visits and abstracted from medical records. The pregnancy-customized SPRING intervention promotes daily behavioral targets of less than 9 hours of SED and at least 7,500 steps, achieved via increased standing and incorporating light-intensity movement breaks each hour. The multi-component intervention provides a height-adjustable workstation, a wearable activity monitor, behavioral counseling every two weeks (videoconference), and membership in a private social media group. Herein, we review the rationale, describe recruitment and screening processes, and detail the intervention, assessment protocols, and planned statistical analyses.
Results:
This study was funded by the American Heart Association (20TPA3549099) beginning January 1, 2021. Participants were randomized between October 2021 and September 2022, with final data collection planned for May 2023.
Conclusions:
The SPRING RCT will provide initial evidence on the feasibility and acceptability of a SED-reduction intervention to decrease SED in pregnant women. These data will inform the design of a large clinical trial testing SED-reduction as a strategy to reduce APO risk. Clinical Trial: clincialtrials.gov NCT05093842, https://clinicaltrials.gov/ct2/show/NCT05093842
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