Sedentary Behavior Reduction in Pregnancy Intervention Study

NCT05093842 | Completed Results

• 2 other identifiers: STUDY20110193AHA 20TPA35490099
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy Complications; Sedentary Behavior

Keywords

Behavioral Intervention; Randomized Clinical Trial; Pregnancy

Outcome Measures

Primary Outcomes (3)

• Sedentary Time

  objectively measured using activPAL3 micro

  Randomization to study completion, about 6 months

• Standing

  Objectively measured using activPAL3 micro

  Randomization to study completion, about 6 months

• Steps Per Day

  Objectively measured using activPAL3 micro

  Randomization to study completion, about 6 months

Secondary Outcomes (4)

• Recruitment

  Active recruitment phase, about 1 year

• Retention

  Beginning of randomization to 2nd trimester and 3rd trimester

• Intervention Adherence to Behavioral Coaching Contacts

  Randomization to study completion, about 6 months

• Outcome Assessment Rates

  Second and third trimester visit. Two participants were removed from this analysis due to miscarriage after randomization.

Study Arms (2)

Sedentary Behavior Reduction Intervention

EXPERIMENTAL

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.

Behavioral: Sedentary Behavior Reduction; Behavioral: Information on Physical Activity Recommendations during Pregnancy

Usual Care Control

ACTIVE COMPARATOR

Printable information on physical activity recommendations only

Behavioral: Information on Physical Activity Recommendations during Pregnancy

Interventions

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).

Sedentary Behavior Reduction Intervention

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.

Sedentary Behavior Reduction Intervention; Usual Care Control

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \<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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead
• American Heart Association: collaborator

Study Sites (1)

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

Pittsburgh, Pennsylvania, 15261, United States

Location

Related Publications (2)

• 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.

  PMID: 38605328 DERIVED

• 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.

  PMID: 37314845 DERIVED

MeSH Terms

Conditions

Pregnancy Complications; Sedentary Behavior

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Behavior

Results Point of Contact

• Title: Bethany Barone Gibbs
• Organization: West Virginia University

behany.gibbs@hsc.wvu.edu

304-581-1779

Study Officials

• Bethany B Gibbs

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 23, 2021
• First Posted: October 26, 2021
• Study Start: October 4, 2021
• Primary Completion: March 30, 2023
• Study Completion: June 30, 2023
• Last Updated: January 31, 2025
• Results First Posted: January 31, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)