Sedentary Behavior Reduction in Pregnancy Intervention Study
Condition: Pregnancy Complications; Sedentary Behavior
MeSH terms: Pregnancy Complications
Study type: Interventional

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.
    

Intervention name(s): Sedentary Behavior Reduction; Information on Physical Activity Recommendations during Pregnancy
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Behavioral Intervention; Randomized Clinical Trial; Pregnancy