Pregnancy RelatedINSPiRENCT05455008
INcreasing Steps in PREgnancy Study
A study testing Remotely-delivered health coaching intervention in people with Pregnancy Related and Exercise, run by University of Iowa at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related, Exercise, Sedentary Behavior
- What is being tested?
- Remotely-delivered health coaching intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2020to 31 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 44 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Being tested
- Remotely-delivered health coaching intervention
- Medical subject headings
- Motor Activity, Sedentary Behavior, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remotely-delivered health coaching interventionBehavioural
Single-arm remotely-delivered health coaching intervention to increase physical activity and reduce sedentary behavior during pregnancy, consisting of 12 health coaching sessions.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Remotely-delivered health coaching intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility: recruitment and enrollment
Feasibility will be defined by recruitment and enrollment of at least 50% of eligible women who completed the screening form
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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)
Preliminary efficacy will be determined using paired t-tests to assess activPAL-measured changes in physical activity (stepping minutes/day, standing minutes/day)
Measured: 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)
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)
Measured: Across the second trimester (intensive intervention phase), an average of 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2022
- Study start1 Jul 2020
- Primary completion31 Aug 2021
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-arm remotely-delivered health coaching pilot intervention study
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Collaborators
- Iowa Fraternal Order of Eagles
- Responsible party
- Principal investigator, Kara Whitaker, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05455008
- Sponsor's protocol ID
- 201910845
- Acronym
- INSPiRE
- Status last verified
- Aug 2023
- First submitted
- 27 Jun 2022
- Last updated
- 1 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be made available through the University of Iowa data repository
Publications
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.
PubMed 36184599
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility, Acceptability, and Preliminary Efficacy of a Single-arm, Remotely-delivered Health Coaching Intervention to Increase Physical Activity and Reduce Sedentary Behavior During Pregnancy
- ClinicalTrials.gov ID
- NCT05455008
- Acronym / sponsor ID
- INSPiRE / 201910845
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Collaborators
- Iowa Fraternal Order of Eagles
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 13 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-arm remotely-delivered health coaching pilot intervention study
| Arm | Type | Receives |
|---|---|---|
| Remotely-delivered health coaching intervention | Experimental | Behavioral: Remotely-delivered health coaching interventionSingle-arm remotely-delivered health coaching intervention to increase physical activity and reduce sedentary behavior during pregnancy, consisting of 12 health coaching sessions. |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remotely-delivered health coaching interventionSingle-arm remotely-delivered health coaching intervention to increase physical activity and reduce sedentary behavior during pregnancy, consisting of 12 health coaching sessions. | Behavioural | Remotely-delivered health coaching intervention |
Primary outcome
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
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
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.
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.
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).
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).
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2023.
- Background: PubMed 36184599Whitaker 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.
- Individual participant dataSharing planned: Yes. Data will be made available through the University of Iowa data repository
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remotely-delivered health coaching intervention in people with Pregnancy Related and Exercise, run by University of Iowa at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility: recruitment and enrollment (time frame: Through study completion, an average of 28 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05455008, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2023.