INcreasing Steps in PREgnancy Study

NCT05455008 | Completed

• 1 other identifier: 201910845
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot study will test the feasibility, acceptability, and efficacy of a remotely-delivered intervention for increasing daily physical activity levels and reducing sedentary behavior during pregnancy among women who are insufficiently active (i.e. reporting \<150 minutes/week of moderate intensity activity and/or \<7,000 steps/day). It is hypothesized that women will increase daily steps and decrease total sedentary time across the second trimester of pregnancy.

Conditions

Pregnancy Related; Exercise; Sedentary Behavior; Behavior and Behavior Mechanisms

Outcome Measures

Primary Outcomes (6)

• Feasibility: recruitment and enrollment

  Feasibility will be defined by recruitment and enrollment of at least 50% of eligible women who completed the screening form

  Through study completion, an average of 28 weeks

• Feasibility: retention

  Feasibility will be defined by retention of 85% or more participants from baseline through delivery

  Through study completion, an average of 28 weeks

• Feasibility: adherence

  Feasibility will be defined by adherence if participants attended 75% or more of the health coaching sessions on average and wore and synced their Fitbit device on at least 75% of days from baseline through the end of the intervention.

  Through study completion, an average of 28 weeks

• Acceptability

  Acceptability will be defined as at least 75% of the participants indicating they were satisfied or very satisfied with the program overall.

  Through study completion, an average of 28 weeks

• Efficacy - changes in physical activity (steps/day)

  Preliminary efficacy will be determined using paired t-tests to assess activPAL-measured changes in physical activity (steps/day).

  Across the second trimester (intensive intervention phase), an average of 14 weeks

• Efficacy - changes in sedentary time (min/day)

  Preliminary efficacy will be determined using paired t-tests to assess activPAL-measured changes in sedentary behavior (sedentary minutes/day).

  Across the second trimester (intensive intervention phase), an average of 14 weeks

Secondary Outcomes (2)

• Efficacy - changes in physical activity (stepping min/day and standing min/day)

  Across the second trimester (intensive intervention phase), an average of 14 weeks

• Efficacy - changes in sedentary time (sedentary min/day in bouts of 30 and 60 minutes)

  Across the second trimester (intensive intervention phase), an average of 14 weeks

Study Arms (1)

Remotely-delivered health coaching intervention

EXPERIMENTAL

Single-arm remotely-delivered health coaching intervention to increase physical activity and reduce sedentary behavior during pregnancy, consisting of 12 health coaching sessions.

Behavioral: Remotely-delivered health coaching intervention

Interventions

Remotely-delivered health coaching intervention BEHAVIORAL

Single-arm remotely-delivered health coaching intervention to increase physical activity and reduce sedentary behavior during pregnancy, consisting of 12 health coaching sessions.

Remotely-delivered health coaching intervention

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• less than 13 weeks pregnant
• between 18-44 years of age
• owned smart phone
• able to speak, comprehend, read, and write in English
• self-reported insufficient activity as determined by the PARmed-X for pregnancy (exercising less than 150 minutes per week) and less than 7,000 steps/day

You may not qualify if:

• currently enrolled in another research study about exercise
• physical limitations that prevented exercise
• instructed by a physician to not exercise during pregnancy
• hospitalized for a psychiatric disorder in the past six months
• absolute or relative contraindication to exercise as determined by the PARmed-X for pregnancy
• other serious medical conditions
• averaged \<9,000 steps/day as determined by the activPAL device worn prior to the first coaching session

Sponsors & Collaborators

• University of Iowa: lead
• Iowa Fraternal Order of Eagles: collaborator

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Related Publications (1)

• Whitaker KM, Jones MA, Dziewior J, Anderson M, Anderson C, Gibbs BB, Carr LJ. Feasibility, acceptability, and preliminary efficacy of a single-arm, remotely-delivered health coaching intervention to increase physical activity and reduce sedentary behavior during pregnancy. BMC Pregnancy Childbirth. 2022 Oct 2;22(1):740. doi: 10.1186/s12884-022-05073-4.

  PMID: 36184599 BACKGROUND

MeSH Terms

Conditions

Motor Activity; Sedentary Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Single-arm remotely-delivered health coaching pilot intervention study

Study Record Dates

• First Submitted: June 27, 2022
• First Posted: July 13, 2022
• Study Start: July 1, 2020
• Primary Completion: August 31, 2021
• Study Completion: August 31, 2021
• Last Updated: September 1, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Data will become available after publication of the primary outcomes
• Access Criteria: Open access to de-identified data.

Locations

US (1)