Sedentary Behavior Reduction in Pregnancy Intervention Study

NCT ID: NCT05093842

Last Updated: 2025-01-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-04
• Study Completion Date: 2023-06-30

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.

Conditions

Pregnancy Complications; Sedentary Behavior

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Sedentary Behavior Reduction

Intervention Type: 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

Intervention Type: BEHAVIORAL

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

Usual Care Control

Printable information on physical activity recommendations only

Group Type: ACTIVE_COMPARATOR

Information on Physical Activity Recommendations during Pregnancy

Intervention Type: BEHAVIORAL

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

Interventions

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).

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

American Heart Association

OTHER

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Bethany Barone Gibbs

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bethany B Gibbs

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

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

Pittsburgh, Pennsylvania, United States

Countries

United States

References

Gibbs BB, Kozai AC, McAdoo SN, Davis KD, Savidge MB, Paley JL, Hauspurg A, Catov JM. The sedentary behavior reduction in pregnancy intervention (SPRING) pilot and feasibility randomized trial. BMC Pregnancy Childbirth. 2024 Apr 11;24(1):261. doi: 10.1186/s12884-024-06474-3.

Reference Type: DERIVED

PMID: 38605328 (View on PubMed)

Barone Gibbs B, Kozai AC, McAdoo SN, Bastyr MC, Davis KD, Hauspurg A, Catov JM. Rationale, Design, and Methods for the Sedentary Behavior Reduction in Pregnancy Intervention (SPRING): Protocol for a Pilot and Feasibility Randomized Controlled Trial. JMIR Res Protoc. 2023 Jun 14;12:e48228. doi: 10.2196/48228.

Reference Type: DERIVED

PMID: 37314845 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

AHA 20TPA35490099

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

STUDY20110193

Identifier Type: -

Identifier Source: org_study_id