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

Trial Summary

What is the purpose of this trial?

The overarching goal of this randomized controlled clinical trial is to test the efficacy of the mHealth app (BumptUp) for improving physical activity levels among pregnant and postpartum women in a rural setting. Secondary outcomes include weight status, dietary intake, glucose tolerance, blood pressure, and mental health. Specific Aim 1. Conduct an RCT (N=176) to assess the efficacy of the mHealth intervention for increasing physical activity levels during pregnancy (13-15, 23-25, and 35-37 weeks gestation) and postpartum (6 and 12 weeks) among women in a rural setting. Research Activities: The efficacy of BumptUp® will be determined by measuring physical activity levels (via accelerometry and surveys) between women who use the mobile app (intervention) and women who use only an educational brochure (attention control). Specific Aim 2: Assess the efficacy of the mHealth intervention on important obstetric outcomes including maternal weight status, dietary intake, glucose tolerance, blood pressure, and mental health. Research Activities: Maternal weight status, glucose tolerance, and blood pressure values will be obtained from patient charts. Dietary intake will be assessed via the National Cancer Institute Multifactor Screener. Maternal mental health status will be measured via The Edinberg Postpartum Depression Questionnaire, Center for Epidemiological Studies Depression Scale, and the State-Trait Anxiety Inventory.

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 data supports the effectiveness of the treatment BumptUp App for increasing physical activity during and after pregnancy?

The BumptUp App shows potential for increasing physical activity among pregnant and postpartum women, as a pilot study indicated a trend towards improved exercise self-efficacy (confidence in one's ability to exercise) compared to an educational brochure. However, the app's impact on social support for exercise was not evident, suggesting further research is needed to confirm its effectiveness. ^{1 2 3 4 5}

Is the BumptUp app safe for use during pregnancy?

The available research does not provide specific safety data for the BumptUp app, but it highlights concerns about the credibility and safety of content in pregnancy-related mobile health apps in general. Further studies are needed to ensure the safety and quality of such apps. ^{1 3 6 7 8}

How does the BumptUp treatment differ from other treatments for increasing physical activity during pregnancy?

BumptUp is unique because it is a mobile app specifically designed to increase physical activity among pregnant and postpartum women, addressing the lack of exercise in this group. Unlike other treatments, it offers a convenient, accessible way to engage with exercise programs without the common barriers associated with traditional exercise methods, such as childcare concerns or access to fitness facilities. ^{1 2 3 5 9}

Research Team

Rachel A Tinius, PhD

Principal Investigator

Western Kentucky University

Eligibility Criteria

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

I am between 18 and 44 years old.

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

I can communicate in English.

Timeline

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

A Pilot Study on the Impact of the BumptUp® Mobile App on Physical Activity during and after Pregnancy. [2023]

2. United States 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. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

An Assessment of Mobile Applications Designed to Address Physical Activity During Pregnancy and Postpartum. [2021]

4. United States 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. [2022]

5. New Zealand 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. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Feasibility and Acceptability of Accelerometer Measurement of Physical Activity in Pregnant Adolescents. [2022]

7. England pubmed.ncbi.nlm.nih.gov

The Healthy Pregnancy Research Program: transforming pregnancy research through a ResearchKit app. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Safety considerations for assessing the quality of apps used during pregnancy: A scoping review. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Dose and timing of text messages for increasing physical activity among pregnant women: a randomized controlled trial. [2023]