Cardiovascular (CV) RiskNCT07166822
The Role of Mobile Apps in Promoting Cardiovascular Health and Motivation to Exercise During Pregnancy
A study testing Experimental group using BumptUp mobile exercise app in people with Cardiovascular (CV) Risk and Exercise, run by Old Dominion University at 1 site in United States.
Trial summary
The goal of this study is to determine the effectiveness of a mobile exercise app in improving cardiovascular health and motivation to exercise in pregnant women who are healthy, in their 2nd trimester, between 18-45 years age, and do not do exercise currently. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular (CV) Risk, Exercise
- What is being tested?
- Experimental group using BumptUp mobile exercise app
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2025to 1 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: 18-45 years.
- Pregnant women who are 20-24 weeks pregnant at enrollment
- Sedentary, as defined by completing less than 90 minutes of exercise each week.
- Generally healthy, uncomplicated pregnancies.
- Free of physical limitations that may interfere with alterations in daily physical activity levels.
- Single gestation.
Show all 9Show fewer
- Have a smartphone
- Under the routine medical care of an obstetrician or certified nurse midwife during their current pregnancy.
- Women speaking English.
Who cannot join
- Physician diagnosed cardiovascular/ vascular complications (heart disease, high blood pressure, Raynaud's phenomenon etc.)
- Physician diagnosed metabolic diseases (diabetes, hypothyroidism)
- Musculoskeletal injuries (broken bones, back pain, ankle sprain, muscle pull, etc.)
- Medications that may impact blood vessel function such as hypertension medication (Angiotensin converting enzyme inhibitor, Angiotensin receptor blocker, Calcium channel blocker, beta blocker), lipid lowering agents (statins), Nitrates, steroids, etc.
- Complications associated with pregnancy that would be exacerbated by exercise such as lung disease, persistent spotting/bleeding or Placental Previa, premature labor, ruptured membranes, evidence of intrauterine growth restriction, pregnancy induced hypertension or pre-eclampsia, uncontrolled epileptic fits/seizures.
- Smoking within the previous 3 months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Old Dominion University
Norfolk, Virginia, 23529
Principal investigator, PhD, 757-239-7889, lreynold@odu.edu
About this study
The goal of this study is to determine the effectiveness of a mobile exercise app in improving cardiovascular health and motivation to exercise in pregnant women who are healthy, in their 2nd trimester, between 18-45 years age, and do not do exercise currently. The aims of this study are determine i) the effect of a mobile app (BumptUp) to increase motivation to exercise as assessed by questionnaire, and ii) the changes may occur in cardiovascular health outcomes such as increased percent Flow-Mediated Dilation (FMD), Heart Rate Variability (HRV), and decreased Pulse Wave Velocity (PWV) over an 8-week period of intervention. Researchers will compare this to pregnant women who are healthy, in their 2nd trimester, between 18-45 years age, and who will not be using the mobile app (BumptUp) for exercise. Participants who are in the experimental group will be given access to the mobile app (BumptUp) for 8 weeks. Both the control and experimental group will visit the lab for their baseline measurements (study visit 1), followed by two visits at 4 weeks (study visit 2) and 8 weeks (study visit 3) to have their heart rate variability, arterial stiffness (PWV), and vascular function (FMD) assessed. At each study visit, blood pressure, heart rate, height, and weight will also be measured. Additionally, at all three study visits, participants will fill out a questionnaire to determine motivation to exercise.
- Conditions
- Cardiovascular (CV) Risk, Exercise
- Being tested
- Experimental group using BumptUp mobile exercise app
- Keywords
- pregnant, cardiovascular, mobile app, exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental group using BumptUp mobile exercise appBehavioural
Also called BumptUp app
This BumptUp app has been developed specifically for pregnancy with safety and screening feature. This intervention will be unique since the researchers will evaluate the cardiovascular health outcomes following the 8 weeks of intervention.
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm who will use the BumptUp mobile exercise app | Experimental | This group will have access to "BumptUp" mobile exercise app and will be provided with an educational brochure (Exercise during pregnancy) Receives: Behavioral: Experimental group using BumptUp mobile exercise app |
| Control group | No intervention | This group will have no access to "BumptUp" mobile exercise app and will only be provided with an educational brochure (Exercise during pregnancy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flow mediated dilation
The cardiovascular health via flow mediated dilation (% change from baseline) will be assessed
Measured: 8 weeks of intervention period
Secondary outcomes (1)
Arterial stiffness
Cardiovascular health will be measured via arterial stiffness determining pulse wave velocity (m/sec)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2025
- Study start15 Sep 2025 (estimated)
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular (CV) RiskStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Old Dominion University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leryn Reynolds, Old Dominion University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07166822
- Sponsor's protocol ID
- FF2
- Status last verified
- Sep 2025
- First submitted
- 27 Aug 2025
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Mobile Apps in Promoting Cardiovascular Health and Motivation to Exercise During Pregnancy
- ClinicalTrials.gov ID
- NCT07166822
- Acronym / sponsor ID
- FF2
- Conditions
- Cardiovascular (CV) Risk, Exercise
- Keywords
- pregnant, cardiovascular, mobile app, exercise
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Old Dominion UniversityUniversity, hospital or other
- Study start
- 15 Sep 2025 (estimated)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 10 Sep 2025 (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.
The goal of this study is to determine the effectiveness of a mobile exercise app in improving cardiovascular health and motivation to exercise in pregnant women who are healthy, in their 2nd trimester, between 18-45 years age, and do not do exercise currently. The aims of this study are determine i) the effect of a mobile app (BumptUp) to increase motivation to exercise as assessed by questionnaire, and ii) the changes may occur in cardiovascular health outcomes such as increased percent Flow-Mediated Dilation (FMD), Heart Rate Variability (HRV), and decreased Pulse Wave Velocity (PWV) over an 8-week period of intervention. Researchers will compare this to pregnant women who are healthy, in their 2nd trimester, between 18-45 years age, and who will not be using the mobile app (BumptUp) for exercise. Participants who are in the experimental group will be given access to the mobile app (BumptUp) for 8 weeks. Both the control and experimental group will visit the lab for their baseline measurements (study visit 1), followed by two visits at 4 weeks (study visit 2) and 8 weeks (study visit 3) to have their heart rate variability, arterial stiffness (PWV), and vascular function (FMD) assessed. At each study visit, blood pressure, heart rate, height, and weight will also be measured. Additionally, at all three study visits, participants will fill out a questionnaire to determine motivation to exercise.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental arm who will use the BumptUp mobile exercise app | Experimental | Behavioral: Experimental group using BumptUp mobile exercise appThis group will have access to "BumptUp" mobile exercise app and will be provided with an educational brochure (Exercise during pregnancy) |
| Control group | No intervention | –This group will have no access to "BumptUp" mobile exercise app and will only be provided with an educational brochure (Exercise during pregnancy) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Age: 18-45 years.
- Pregnant women who are 20-24 weeks pregnant at enrollment
- Sedentary, as defined by completing less than 90 minutes of exercise each week.
- Generally healthy, uncomplicated pregnancies.
- Free of physical limitations that may interfere with alterations in daily physical activity levels.
Key exclusion criteria (6 listed)
- Physician diagnosed cardiovascular/ vascular complications (heart disease, high blood pressure, Raynaud's phenomenon etc.)
- Physician diagnosed metabolic diseases (diabetes, hypothyroidism)
- Musculoskeletal injuries (broken bones, back pain, ankle sprain, muscle pull, etc.)
- Medications that may impact blood vessel function such as hypertension medication (Angiotensin converting enzyme inhibitor, Angiotensin receptor blocker, Calcium channel blocker, beta blocker), lipid lowering agents (statins), Nitrates, steroids, etc.
- Complications associated with pregnancy that would be exacerbated by exercise such as lung disease, persistent spotting/bleeding or Placental Previa, premature labor, ruptured membranes, evidence of intrauterine growth restriction, pregnancy induced hypertension or pre-eclampsia, uncontrolled epileptic fits/seizures.
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 |
|---|---|---|
| Experimental group using BumptUp mobile exercise appAlso: BumptUp appThis BumptUp app has been developed specifically for pregnancy with safety and screening feature. This intervention will be unique since the researchers will evaluate the cardiovascular health outcomes following the 8 weeks of intervention. | Behavioural | Experimental arm who will use the BumptUp mobile exercise app |
Primary outcome
Flow mediated dilation
Time frame: 8 weeks of intervention period
The cardiovascular health via flow mediated dilation (% change from baseline) will be assessed
1 secondary outcome
Arterial stiffness
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental group using BumptUp mobile exercise app in people with Cardiovascular (CV) Risk and Exercise, run by Old Dominion University 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 9 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 10 Sep 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Principal Investigator, PhD (757-683-4974, lreynold@odu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Flow mediated dilation (time frame: 8 weeks of intervention period). 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 10 Sep 2025.