Pregnancy RelatedNCT04903574
An mHealth Intervention for Sedentary Behavior in Pregnant Women
A study testing NEAT!2 sedentary behavior app and Pregnancy smartphone app in people with Pregnancy Related and Sedentary Behavior, run by University of South Carolina at 1 site in United States.
Trial summary
Pregnancy outcomes, such as excessive gestational weight gain and gestational diabetes, are linked to long and short-term maternal and child health. Interventions aimed at improving health behaviors, such as sedentary behavior (SB; i.e., any behavior in a seated or reclining position with low energy expenditure) are… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related, Sedentary Behavior
- What is being tested?
- NEAT!2 sedentary behavior app and Pregnancy smartphone app
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Dec 2021to 20 Jul 2023
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- currently <16 weeks pregnant with a single infant
- at least 18 years old
- normal weight, overweight, or obese body mass index prior to pregnancy
- can read English at a 6th grade level
- planning to continue pregnancy to term
- owns smartphone and keeps it within arms reach during the day
- willing to allow medical chart access for specific information during the current pregnancy
- no absolute contraindications to exercise, i.e., a doctor has not told you not to exercise during pregnancy
Who cannot join
- pre-pregnancy BMI <18.5 kg/m2
- age <18 years
- gestational age >16 weeks
- multiple gestation
- not planning to continue pregnancy to term
- does not own a smartphone or keep smartphone within arms-reach during the day
Show all 10Show fewer
- pre-pregnancy type I or II diabetes
- absolute contraindication to PA in pregnancy
- not receiving prenatal care or not willing to allow access to medical chart
- inability to read English at a 6th grade level.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of South Carolina
Columbia, South Carolina, 29208
About this study
Pregnancy outcomes, such as excessive gestational weight gain and gestational diabetes, are linked to long and short-term maternal and child health. Interventions aimed at improving health behaviors, such as sedentary behavior (SB; i.e., any behavior in a seated or reclining position with low energy expenditure) are attractive because they are low-cost, can be disseminated in a wide variety of populations once pregnancy begins, and do not require drugs or prescriptions. Studies have linked SB to some pregnancy outcomes. To the investigators' knowledge, no studies have tested the efficacy of an intervention to reduce SB in pregnant women.
Over 90% of reproductive aged women own a smartphone with similar rates of ownership among black, white, and Hispanic/Latina women, and most adults carry smartphones while awake. Smartphones can monitor SB without additional equipment. Thus, smartphones offer a streamlined opportunity to intervene on SB. The purpose of the research is to evaluate the effectiveness and perception of an mHealth intervention aimed at changing SB in pregnant women. Investigators will survey providers regarding their SB opinions and counseling practices
Read the detailed description
Investigators will recruit 28 pregnant women, 14 per arm, to participate in this pilot randomized, controlled study. Particiants will complete an in-person baseline study visit in early pregnancy (< week 16). The visit will occur in the Public Health Research Center, Discovery Building, or at a Prisma Health facility. Measurements at the in-person visit (~ 1 hr) include demographics, surveys regarding current and pre-pregnancy PA and SB, medical and pregnancy history, height, and weight. All participants will be given an activPAL(TM) (Glasgow, UK) at V1 to objectively measure SB for 1 week using gold-standard methodology. At the end of the 1-week run-in period (i.e., the week during which SB is objectively measured prior to randomization), participants will mail back the activPAL(TM) and be randomized to the mHealth SB intervention or control group for 12 weeks. SB will be objectively measured again using the activPAL(TM) from week 11-12 of the study. Surveys (Nausea and Vomiting of Pregnancy, Global Health Scales, inquiry about new diagnoses) will be administered remotely in week 5 and week 11. A recruitment opinion survey will be administered remotely in week 5 to inform future recruitment efforts. Surveys related to the intervention platform and perceived effectiveness will be administered remotely at week 12 to participants in the experimental group. Investigators will ask about new diagnoses or adverse events at week 5 and week 11. Investigators will link to participants' medical charts and abstract in-clinic body weight, the results of the third trimester glucose tolerance test, and any other pregnancy-related diagnoses. Investigators will survey Ob/Gyn clinicians (doctors, residents, and nurses) regarding their perceptions of SB during pregnancy.
- Conditions
- Pregnancy Related, Sedentary Behavior
- Being tested
- NEAT!2 sedentary behavior app, Pregnancy smartphone app
- Keywords
- Pregnancy, Smartphone, mHealth
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NEAT!2 sedentary behavior appBehavioural
This is a smartphone app that reminds you to stand up if you've been sitting for at least 30 minutes.
Pregnancy smartphone appOther
This is a commercially available general pregnancy smartphone app
| Study group | Role | What they receive |
|---|---|---|
| Sedentary behavior smartphone app | Experimental | This arm will be assigned to download and use a smartphone app that prompts you to stand up when your smartphone detects 30 minutes of sitting. Receives: Behavioral: NEAT!2 sedentary behavior app |
| Pregnancy smartphone app | Active comparator | This arm will download and use a commercially available pregnancy smartphone app that does not attempt to change activity behavior. Receives: Other: Pregnancy smartphone app |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time spent in sedentary behavior
Total minutes/day in sedentary behavior
Measured: Week 11-12 of the intervention
Weight gain
Pregnancy weight gain
Measured: At delivery
Glucose tolerance test results
The blood glucose level at the third trimester glucose tolerance test
Measured: At clinic 1 ay visit glucose test
Secondary outcomes (3)
Pregnant patients' opinions of sedentary behavior
Survey regarding feelings about sedentary behavior during pregnancy
Measured: Baseline (before randomization)
Pregnant patients' opinions of the NEAT!2 app
Survey regarding feelings about the app for those assigned to the experimental group
Measured: Week 12
Providers' opinions and practices regarding sedentary behavior
MD/DO, RN, NP opinions and counseling practices related to sedentary behavior in pregnant patients
Measured: until study is completed; about 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2021
- Study start17 Dec 2021
- Primary completion20 Jul 2023
- Study completion20 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- More trials run by University of South CarolinaThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- Prisma Health-Midlands
- Responsible party
- Principal investigator, Abbi Danielle Lane-Cordova, University of South Carolina
- Investigators
- Abbi D Lane-Cordova, PhD, Principal investigator, University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04903574
- Sponsor's protocol ID
- Pro00110591
- Status last verified
- Aug 2024
- First submitted
- 14 May 2021
- Last updated
- 6 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We are willing to share deidentified data with other researchers. Researchers can contact us if they are interested.
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An mHealth Intervention for Sedentary Behavior in Pregnant Women
- ClinicalTrials.gov ID
- NCT04903574
- Acronym / sponsor ID
- Pro00110591
- Conditions
- Pregnancy Related, Sedentary Behavior
- Keywords
- Pregnancy, Smartphone, mHealth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Collaborators
- Prisma Health-Midlands
- Study start
- 17 Dec 2021 (actual)
- Primary completion
- 20 Jul 2023 (actual)
- Study completion
- 20 Jul 2023 (actual)
- First posted
- 26 May 2021 (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.
Pregnancy outcomes, such as excessive gestational weight gain and gestational diabetes, are linked to long and short-term maternal and child health. Interventions aimed at improving health behaviors, such as sedentary behavior (SB; i.e., any behavior in a seated or reclining position with low energy expenditure) are attractive because they are low-cost, can be disseminated in a wide variety of populations once pregnancy begins, and do not require drugs or prescriptions. Studies have linked SB to some pregnancy outcomes. To the investigators' knowledge, no studies have tested the efficacy of an intervention to reduce SB in pregnant women.
Over 90% of reproductive aged women own a smartphone with similar rates of ownership among black, white, and Hispanic/Latina women, and most adults carry smartphones while awake. Smartphones can monitor SB without additional equipment. Thus, smartphones offer a streamlined opportunity to intervene on SB. The purpose of the research is to evaluate the effectiveness and perception of an mHealth intervention aimed at changing SB in pregnant women. Investigators will survey providers regarding their SB opinions and counseling practices
Detailed description
Investigators will recruit 28 pregnant women, 14 per arm, to participate in this pilot randomized, controlled study. Particiants will complete an in-person baseline study visit in early pregnancy (< week 16). The visit will occur in the Public Health Research Center, Discovery Building, or at a Prisma Health facility. Measurements at the in-person visit (~ 1 hr) include demographics, surveys regarding current and pre-pregnancy PA and SB, medical and pregnancy history, height, and weight. All participants will be given an activPAL(TM) (Glasgow, UK) at V1 to objectively measure SB for 1 week using gold-standard methodology. At the end of the 1-week run-in period (i.e., the week during which SB is objectively measured prior to randomization), participants will mail back the activPAL(TM) and be randomized to the mHealth SB intervention or control group for 12 weeks. SB will be objectively measured again using the activPAL(TM) from week 11-12 of the study. Surveys (Nausea and Vomiting of Pregnancy, Global Health Scales, inquiry about new diagnoses) will be administered remotely in week 5 and week 11. A recruitment opinion survey will be administered remotely in week 5 to inform future recruitment efforts. Surveys related to the intervention platform and perceived effectiveness will be administered remotely at week 12 to participants in the experimental group. Investigators will ask about new diagnoses or adverse events at week 5 and week 11. Investigators will link to participants' medical charts and abstract in-clinic body weight, the results of the third trimester glucose tolerance test, and any other pregnancy-related diagnoses. Investigators will survey Ob/Gyn clinicians (doctors, residents, and nurses) regarding their perceptions of SB during pregnancy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sedentary behavior smartphone app | Experimental | Behavioral: NEAT!2 sedentary behavior appThis arm will be assigned to download and use a smartphone app that prompts you to stand up when your smartphone detects 30 minutes of sitting. |
| Pregnancy smartphone app | Active comparator | Other: Pregnancy smartphone appThis arm will download and use a commercially available pregnancy smartphone app that does not attempt to change activity behavior. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- currently <16 weeks pregnant with a single infant
- at least 18 years old
- normal weight, overweight, or obese body mass index prior to pregnancy
- can read English at a 6th grade level
- planning to continue pregnancy to term
Key exclusion criteria (10 listed)
- pre-pregnancy BMI <18.5 kg/m2
- age <18 years
- gestational age >16 weeks
- multiple gestation
- not planning to continue pregnancy to term
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 |
|---|---|---|
| NEAT!2 sedentary behavior appThis is a smartphone app that reminds you to stand up if you've been sitting for at least 30 minutes. | Behavioural | Sedentary behavior smartphone app |
| Pregnancy smartphone appThis is a commercially available general pregnancy smartphone app | Other | Pregnancy smartphone app |
Primary outcome
Time spent in sedentary behavior
Time frame: Week 11-12 of the intervention
Total minutes/day in sedentary behavior
Weight gain
Time frame: At delivery
Pregnancy weight gain
Glucose tolerance test results
Time frame: At clinic 1 ay visit glucose test
The blood glucose level at the third trimester glucose tolerance test
3 secondary outcomes
Pregnant patients' opinions of sedentary behavior
Time frame: Baseline (before randomization)
Pregnant patients' opinions of the NEAT!2 app
Time frame: Week 12
Providers' opinions and practices regarding sedentary behavior
Time frame: until study is completed; about 1 year
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 6 Aug 2024.
- Individual participant dataSharing planned: Undecided. We are willing to share deidentified data with other researchers. Researchers can contact us if they are interested.
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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.
Abbi D Lane-Cordova, PhD principal investigator
University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NEAT!2 sedentary behavior app and Pregnancy smartphone app in people with Pregnancy Related and Sedentary Behavior, run by University of South Carolina 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 8 inclusion and 10 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 6 Aug 2024. 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?
Time spent in sedentary behavior (time frame: Week 11-12 of the intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Aug 2024.