Mobile Exercise App for Cardiovascular Health During Pregnancy

Overseen By Principal Investigator, PhD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Old Dominion University

Must not be taking: Hypertension meds, Statins, Steroids

Disqualifiers: Cardiovascular, Metabolic, Musculoskeletal, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 8 weeks

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a mobile exercise app, called BumptUp, can improve heart health and exercise motivation in pregnant women. It targets healthy women in their second trimester who are not currently exercising. Participants will either use the app or receive a brochure about exercise during pregnancy. Ideal candidates are between 20-24 weeks pregnant, exercise less than 90 minutes a week, and have no pregnancy complications. The study will monitor changes in heart health and motivation over eight weeks. As an unphased trial, this study provides a unique opportunity for participants to contribute to research that could enhance exercise motivation and heart health during pregnancy.

Will I have to stop taking my current medications?

The trial excludes participants who are taking medications that may affect blood vessel function, like blood pressure medications or statins. If you're on such medications, you may not be eligible to participate.

What prior data suggests that the BumptUp mobile exercise app is safe for pregnant women?

Research has shown that the BumptUp app is safe for pregnant women. It offers exercise programs based on scientific evidence and carefully reviewed. A small initial study examined BumptUp's impact on physical activity in pregnant women and found no serious side effects. The app aims to help pregnant women exercise safely.

BumptUp is part of a broader effort to support a healthy pregnancy and recovery after childbirth, indicating its intent to be both safe and beneficial for users. However, specific data on side effects or safety issues from these studies remain limited. As a non-invasive app focused on guiding exercise, the risks are likely low, but individual experiences may vary. It is important to consult a healthcare provider before starting new exercise routines during pregnancy. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about BumptUp because it offers a new way to enhance cardiovascular health during pregnancy through a mobile exercise app. Unlike traditional advice and educational brochures, BumptUp provides interactive features and personalized exercise plans that can be easily accessed from a smartphone. This approach not only makes exercise more convenient for pregnant individuals but also encourages consistent engagement, which is crucial for maintaining cardiovascular health. Additionally, it leverages technology to offer real-time feedback and motivation, setting it apart from existing options.

What evidence suggests that the BumptUp mobile exercise app is effective for improving cardiovascular health during pregnancy?

Research has shown that mobile apps can improve heart health by encouraging increased activity. In this trial, participants in the experimental arm will use the BumptUp app, designed specifically for pregnancy, offering safe and effective workouts. A small study on the BumptUp app found it might help pregnant women exercise more. In earlier studies, users reported feeling more motivated to exercise, which is important for heart health. Early results also suggested possible improvements in heart rate and blood vessel health. This suggests BumptUp might help pregnant women stay active and support their heart health. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

This trial is for healthy pregnant women in their 2nd trimester, aged between 18-45, who currently do not exercise. It aims to see if a mobile app (BumptUp) can boost their motivation to work out and improve cardiovascular health.

Inclusion Criteria

Sedentary, as defined by completing less than 90 minutes of exercise each week

Generally healthy, uncomplicated pregnancies

Single gestation

Exclusion Criteria

Smoking within the previous 3 months

I have been diagnosed with a heart or blood vessel condition.

I have been diagnosed with a metabolic disease like diabetes or hypothyroidism.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants visit the lab for baseline measurements including heart rate variability, arterial stiffness, and vascular function

1 day

1 visit (in-person)

Treatment

Participants in the experimental group use the BumptUp mobile app for 8 weeks, with assessments at 4 and 8 weeks

8 weeks

3 visits (in-person)

Follow-up

Participants are monitored for changes in cardiovascular health and motivation to exercise

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BumptUp

Trial Overview The study tests the BumptUp mobile app's effectiveness on increasing exercise motivation and improving cardiovascular markers like Flow-Mediated Dilation, Heart Rate Variability, and Pulse Wave Velocity over an 8-week period compared to those without the app.

How Is the Trial Designed?

Group I: Experimental arm who will use the BumptUp mobile exercise app Experimental Treatment 1 Intervention

This group will have access to "BumptUp" mobile exercise app and will be provided with an educational brochure (Exercise during pregnancy)

Group II: Control group Active Control 1 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 Is Running the Clinical Trial?

Old Dominion University

Lead Sponsor

Trials

25

Recruited

15,500+

Citations

1. sbir.gov sbir.gov/awards/213620

Award | SBIR created BumptUp®, the first mobile health app to provide pregnant and postpartum women with careful screening and evidence-based, safe exercise programming.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07166822

The Role of Mobile Apps in Promoting Cardiovascular ... This BumptUp app has been developed specifically for pregnancy with safety and screening feature. This intervention will be unique since the ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10574187/

A Pilot Study on the Impact of the BumptUp® Mobile App ... The primary goal of this pilot study was to test the potential efficacy of BumptUp for improving physical activity among pregnant and postpartum women.

4. bumptupapp.com bumptupapp.com/pilot-study-on-the-impact-of-the-bumptup/

A Pilot Study on the Impact of the BumptUp® MobileApp ... The primary goal of this pilot study was to test the potential efficacy of BumptUp® for improving physical activity among pregnant and ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/jocn.70112?af=R

Effectiveness of E‐Health Interventions on Improving ... “A Pilot Study on the Impact of the BumptUp Mobile App on Physical Activity During and After Pregnancy.” Sustainability 14, no. 19: 12801 ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05849649

Mobile Application-based Exercise Intervention for ... These data include height, weight, and blood pressure results at prenatal appointments that correspond to data collection time points (i.e., 12-17 weeks, 23 ...

7. bumptupapp.com bumptupapp.com/

BumptUp – For a healthy pregnancy & postpartum journey. BumptUp offers features that will help guide you through a healthy pregnancy and postpartum journey.