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Completed

NCT Number: NCT05093842

Sedentary Behavior Reduction in Pregnancy Intervention Study

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Pittsburgh, Department of Health and Human Development, 32 Oak Hill Court, Room 220

Pittsburgh, Pennsylvania, 15261, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sedentary Behavior Reduction

Behavioral

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

Behavioral

Participants in the study will receive educational materials provided one time by email about the currently recommended physical activity during pregnancy.

Primary outcomes

  1. Sedentary Time

    Time frame: Randomization to study completion, about 6 months

    objectively measured using activPAL3 micro

  2. Standing

    Time frame: Randomization to study completion, about 6 months

    Objectively measured using activPAL3 micro

  3. Steps Per Day

    Time frame: Randomization to study completion, about 6 months

    Objectively measured using activPAL3 micro

Secondary outcomes

  1. Recruitment

    Time frame: Active recruitment phase, about 1 year

    Participants screened for eligibility

  2. Retention

    Time frame: Beginning of randomization to 2nd trimester and 3rd trimester

    Number of randomized intervention and control participants remaining at each follow up timepoint

  3. Intervention Adherence to Behavioral Coaching Contacts

    Time frame: Randomization to study completion, about 6 months

    Percentage of intervention contacts completed. This includes behavioral lessons and check-ins.

  4. Outcome Assessment Rates

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • American Heart Association

Registry information

Acronym: SPRING

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Oct 26, 2021
Registry last updated
Jan 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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