Mobile App Exercise Intervention for Pregnancy

Overseen By Rachel A Tinius, PhD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Western Kentucky University

Disqualifiers: Multiple gestation, Inability to consent, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

176 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a mobile app called BumptUp to determine if it helps pregnant and postpartum women in rural areas increase their exercise. It also examines the app's potential effects on weight, diet, blood sugar, blood pressure, and mental health. Participants will either use the app or receive an educational brochure about exercise. Women who are pregnant with one baby, have a doctor's approval to exercise, and own a smartphone may be suitable for this study. As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance health resources for women in rural areas.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this mobile app is safe for pregnant and postpartum women?

Research shows that the BumptUp mobile app safely guides pregnant and postpartum women in exercising. The app offers exercises tailored to different fitness levels, ensuring suitability for this group. Studies confirm that the app's content is grounded in scientific research, supporting its safety during pregnancy and after childbirth.

No reports indicate any problems or safety issues with using the BumptUp app. The app aims to help users stay active, which benefits both mothers and babies during pregnancy and postpartum.

As an exercise and lifestyle app, it doesn't involve medication or medical procedures, which typically raise more safety concerns. The main focus is ensuring the exercises and advice are appropriate for pregnant women, a goal the app achieves through its research-backed approach. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the BumptUp mobile app because it offers a comprehensive and innovative approach to exercise during pregnancy. Unlike traditional methods that might involve static educational materials or generic exercise recommendations, BumptUp provides personalized exercise programs, dietary progress tracking, and social support all in one convenient app. This integration of evidence-based, safe exercise routines with real-time symptom tracking and community connection makes it a unique tool for expecting mothers, potentially improving adherence and outcomes compared to standard care options like one-time educational brochures.

What evidence suggests that the BumptUp app is effective for improving physical activity during pregnancy?

Research has shown that the BumptUp mobile app, available to participants in this trial, might help pregnant and new mothers become more active. A small study found that women using the app moved more than those who did not. Regular exercise during and after pregnancy benefits both mother and baby. The app offers exercise plans, tracks progress, and provides social support, making it easier for women to stay active. Although more research is needed, these early results are promising for improving health during pregnancy and beyond. ^{1 4 6 7 8}

Who Is on the Research Team?

Rachel A Tinius, PhD

Principal Investigator

Western Kentucky University

Are You a Good Fit for This Trial?

This trial is for English-speaking pregnant women aged 18-44 with a confirmed singleton pregnancy, who own a smartphone and plan to deliver at The Medical Center in Bowling Green, KY. They must be patients at specific clinics and have physician approval to exercise.

Inclusion Criteria

Your doctor has given permission for you to exercise before joining the study.

I can communicate in English.

You have a smartphone.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment and Randomization

Baseline assessment at 13-15 weeks gestation followed by randomization to intervention or control group

1 week

1 visit (in-person)

Intervention

Participants use the mHealth app or receive educational brochure to improve physical activity levels during pregnancy and postpartum

39 weeks

3 check-ins (telephone)

Follow-up

Participants are monitored for physical activity, weight status, glucose tolerance, blood pressure, and mental health postpartum

12 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• BumptUp
• Educational Brochure

Trial Overview The study tests if the BumptUp mobile app can boost physical activity levels among rural pregnant/postpartum women compared to those just using an educational brochure. It also looks at effects on weight, diet, glucose tolerance, blood pressure, and mental health.

How Is the Trial Designed?

Group I: BumptUp Mobile App Experimental Treatment 1 Intervention

The intervention group will have full access to the BumptUp mobile app which includes exercise and dietary progress tracking, social support, evidence-based and safe exercise programming, videos, and symptom tracking.

Group II: Educational Brochure/ Attention Control Active Control 1 Intervention

This group will receive evidence-based exercise education the form a one-time brochure.

BumptUp is already approved in United States for the following indications:

Approved in United States as BumptUp for:

• Improving physical activity levels among pregnant and postpartum women
• Weight status management
• Dietary intake guidance
• Glucose tolerance monitoring
• Blood pressure management
• Mental health support

Who Is Running the Clinical Trial?

Western Kentucky University

Lead Sponsor

Trials

12

Recruited

1,400+

Published Research Related to This Trial

Women with overweight and obese BMI categories reported significantly lower levels of perceived social support for exercise during pregnancy and postpartum compared to those in the lean category, indicating a potential barrier to physical activity for these groups.

The BumptUp® mobile application did not show a statistically significant improvement in perceived social support for exercise compared to the control group, suggesting that while it may provide some benefits, its efficacy in enhancing social support during pregnancy and postpartum needs further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Social support for exercise from pregnancy to postpartum and the potential impact of a mobile application: A randomized control pilot trial in Southern United States. Perera, M., Hawk, GS., Nagpal, TS., et al.[2023]

Pregnant and postpartum women in rural areas see physical activity as essential for weight control and want reliable, evidence-based exercise information to guide their activities.

Key features desired in a mobile app include goal setting, progress tracking, tailored exercise guidance, social support, symptom tracking, and time-efficient workouts, which can help overcome barriers to physical activity during and after pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Obstetric Patients and Healthcare Providers Perspectives to Inform Mobile App Design for Physical Activity and Weight Control During Pregnancy and Postpartum in a Rural Setting. Tinius, R., Duchette, C., Beasley, S., et al.[2022]

A pilot study involving 35 pregnant and postpartum women tested the BumptUp® mobile app, which aims to increase physical activity levels, showing a trend towards improved physical activity over time compared to a control group that received an educational brochure.

The study found a significant decrease in self-efficacy for exercise among the control group compared to the BumptUp® group during late pregnancy, indicating that the app may help maintain motivation for physical activity during this period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Pilot Study on the Impact of the BumptUp® Mobile App on Physical Activity during and after Pregnancy. Tinius, RA., Blankenship, MM., Colao, AM., et al.[2023]

A study involving 80 pregnant women found that sending physical activity-specific text messages (SMS) through the Text4baby service did not lead to increased physical activity, regardless of how often the messages were sent.

Interestingly, participants who received six SMS per week actually showed greater decreases in activity and increased sedentary time, suggesting that SMS alone may not be an effective strategy for promoting physical activity during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dose and timing of text messages for increasing physical activity among pregnant women: a randomized controlled trial. Huberty, JL., Buman, MP., Leiferman, JA., et al.[2023]

In a pilot study involving 36 pregnant adolescents, the use of wrist-worn accelerometers to assess physical activity was found to be neither feasible nor acceptable, with only 51.5% achieving the minimum of 4 days of valid wear.

Participants rated the acceptability of accelerometer use as neutral, suggesting that future research should explore better incentives and possibly lower wear-time requirements to improve adherence in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and Acceptability of Accelerometer Measurement of Physical Activity in Pregnant Adolescents. Clark, ELM., Gulley, LD., Hilkin, AM., et al.[2022]

A new smartphone app designed for pregnant women has successfully enrolled 2058 participants across all 50 states, allowing for large-scale data collection on factors influencing healthy pregnancies.

The study collected over 14,000 surveys and more than 107,000 daily measurements related to health metrics, demonstrating the app's potential to gather valuable data that can improve maternal and fetal health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Healthy Pregnancy Research Program: transforming pregnancy research through a ResearchKit app. Radin, JM., Steinhubl, SR., Su, AI., et al.[2020]

A scoping review of 16 studies found that pregnancy-specific apps often lack transparency and credibility regarding the information they provide, which raises safety concerns for users.

Key safety considerations identified include the need for better protection of personal data, the importance of evidence-based content, and the necessity for apps to be tailored to local guidelines and users' digital health literacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety considerations for assessing the quality of apps used during pregnancy: A scoping review. Carrandi, A., Hayman, M., Harrison, CL.[2023]

Pregnant women who used the SmartMoms Canada app more frequently (at least 3.8 minutes per week) showed a significant increase in their daily moderate-to-vigorous physical activity (MVPA) by an average of 17.84 minutes compared to those with lower usage.

Higher app usage was associated with better adherence to gestational weight gain guidelines, with 28.6% of higher usage participants meeting the guidelines compared to 15.4% of lower usage participants, indicating the app's potential effectiveness in promoting healthy behaviors during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The short-term effect of a mHealth intervention on gestational weight gain and health behaviors: The SmartMoms Canada pilot study. Souza, SCS., da Silva, DF., Nagpal, TS., et al.[2022]

Only 15% of women meet physical activity guidelines during and after pregnancy, highlighting a significant gap in support and guidance for this important health aspect.

A review of 54 mobile apps related to physical activity during pregnancy and postpartum revealed that most apps (61.1%) had hidden costs, and none provided specific goal-setting features, indicating that current mobile health interventions are of low quality and insufficient to help women achieve recommended activity levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Assessment of Mobile Applications Designed to Address Physical Activity During Pregnancy and Postpartum. Tinius, RA., Polston, M., Bradshaw, H., et al.[2021]

Citations

1. bumptupapp.com bumptupapp.com/

BumptUp – For a healthy pregnancy & postpartum journey. Research showed an unmet need to develop strategies that reduce obesity rates and increase physical activity levels during pregnancy and postpartum, ...

2. 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 ...

3. reporter.nih.gov reporter.nih.gov/search/mzBu__Vkv0m_bdkYGZDxVw/project-details/10919604

Clinical Testing and Refinement of BumptUp®: A ... - NIH RePORTER Fortunately, physical activity during and after pregnancy improves maternal and infant outcomes. Professionals recommend all pregnant women exercise for 150 ...

4. 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.

5. apps.apple.com apps.apple.com/us/app/bumptup/id1544666805

BumptUp on the App Store BumptUp provides safe, effective, inclusive evidence-based physical activity guidance to pregnant & postpartum women.

6. bumptupapp.com bumptupapp.com/about/

About BumptUp provides safe, effective, inclusive, evidence-based physical activity guidance to pregnant and postpartum women, helping them stay active during and ...

7. mdpi.com mdpi.com/2071-1050/14/19/12801

A Pilot Study on the Impact of the BumptUp® Mobile App ... Mobile apps designed to alter lifestyle during pregnancy have been unable to elicit statistically significant differences in physical activity among ...

8. play.google.com play.google.com/store/apps/details?id=org.bumptup.app&hl=en_US

BumptUp - Apps on Google Play BumptUp provides safe, effective, inclusive evidence-based physical activity guidance to pregnant & postpartum women.