INcreasing Steps in PREgnancy Study (INSPiRE)

August 29, 2023 updated by: Kara Whitaker, University of Iowa

Feasibility, Acceptability, and Preliminary Efficacy of a Single-arm, Remotely-delivered Health Coaching Intervention to Increase Physical Activity and Reduce Sedentary Behavior During Pregnancy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Physical activity during pregnancy is safe for the mother and baby and has many health benefits; however, less than 25% of pregnant women meet the recommended physical activity guidelines. Data from the investigative team also indicates that high sedentary behavior across pregnancy trimesters is associated with an increased risk of hypertensive disorders of pregnancy and other adverse pregnancy outcomes, independent of physical activity level. There is a clear need to encourage physical activity participation while concurrently promoting a reduction in sedentary time during pregnancy.

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). We hypothesized that participants would increase daily steps and decrease total sedentary time over the course of the intensive intervention phase (second trimester, ~14 weeks). Further, we hypothesized that participants would maintain or have minimal changes in daily steps and total sedentary time from the end of the intensive intervention phase through the follow-up phase (third trimester, ~14 weeks).

Intervention Summary: Participants have 12 contacts with a health coach using a telehealth platform to provide ongoing support and discuss physical activity and sedentary behavior goals based on real-time data obtained from a Fitbit monitor. Intervention contacts will be weekly for the first month, bi-monthly in months 2-4, and monthly until delivery. Participants will also receive one text message between each intervention contact to reinforce content discussed in coaching sessions. Physical activity and sedentary time will be assessed objectively using an activPAL device for 7-days at baseline and at the end of the intensive intervention phase (second trimester, ~14 weeks).

Specific Aims:

Aim 1: To test the feasibility of a remotely-delivered intervention designed to increase physical activity levels and reduce sedentary behavior during pregnancy. Feasibility will be defined by: (1) recruitment and enrollment of at least 50% of eligible women who completed the screening form, (2) retention of 85% or more participants from baseline through delivery, (3) 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.

Aim 2: To test the acceptability of a remotely-delivered intervention designed to increase physical activity levels and reduce sedentary behavior during pregnancy. Acceptability will be defined as at least 75% of the participants indicating they were satisfied or very satisfied with the program overall.

Aim 3: To test the preliminary efficacy of a remotely-delivered intervention designed to increase physical activity levels and reduce sedentary behavior during pregnancy. Efficacy will be determined using paired t-tests to assess activPAL-measured changes in physical activity (steps/day, stepping minutes/day, standing minutes/day) and sedentary behavior (sedentary minutes/day, total and in bouts of 30 and 60 minutes) from baseline through the end of the second trimester (intensive intervention phase). The intervention specifically aims to increase physical activity levels and reduce sedentary behavior from enrollment through the end of the second trimester of pregnancy (intensive intervention phase), and then will encourage participants to maintain activity levels based on their comfort level through the third trimester (follow-up phase).

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 44 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Remotely-delivered health coaching intervention
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
Single-arm remotely-delivered health coaching intervention to increase physical activity and reduce sedentary behavior during pregnancy, consisting of 12 health coaching sessions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility: recruitment and enrollment
Time Frame: Through study completion, an average of 28 weeks
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
Time Frame: Through study completion, an average of 28 weeks
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
Time Frame: Through study completion, an average of 28 weeks
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
Time Frame: Through study completion, an average of 28 weeks
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)
Time Frame: Across the second trimester (intensive intervention phase), an average of 14 weeks
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)
Time Frame: Across the second trimester (intensive intervention phase), an average of 14 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy - changes in physical activity (stepping min/day and standing min/day)
Time Frame: Across the second trimester (intensive intervention phase), an average of 14 weeks
Preliminary efficacy will be determined using paired t-tests to assess activPAL-measured changes in physical activity (stepping minutes/day, standing minutes/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)
Time Frame: Across the second trimester (intensive intervention phase), an average of 14 weeks
Preliminary efficacy will be determined using paired t-tests to assess activPAL-measured changes in sedentary behavior (sedentary minutes/day in bouts of 30 and 60 minutes)
Across the second trimester (intensive intervention phase), an average of 14 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Iowa

Collaborators

Iowa Fraternal Order of Eagles

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2020

Primary Completion (Actual)

August 31, 2021

Study Completion (Actual)

August 31, 2021

Study Registration Dates

First Submitted

June 27, 2022

First Submitted That Met QC Criteria

July 8, 2022

First Posted (Actual)

July 13, 2022

Study Record Updates

Last Update Posted (Actual)

September 1, 2023

Last Update Submitted That Met QC Criteria

August 29, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 201910845

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be made available through the University of Iowa data repository

IPD Sharing Time Frame

Data will become available after publication of the primary outcomes

IPD Sharing Access Criteria

Open access to de-identified data.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

Study Data/Documents

  1. Individual Participant Data Set

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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