NCT05849649 · Western Kentucky University
Mobile Application-based Exercise Intervention for Pregnant Women
What this study is about
The overarching goal of this randomly assigned controlled clinical trial is to test the effectiveness 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.
View original scientific description
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.
Interventions
BEHAVIORAL
BumptUp
The app contains a number of evidence-based, expertly designed features to help women with healthier lifestyle habits during and after pregnancy.
BEHAVIORAL
Educational Brochure
An evidence-based brochure on physical activity
Primary outcome measures
Physical activity level (objective)
Time frame: 13-15 weeks gestation
Measured via Actigraph accelerators
Physical activity level (objective)
Time frame: 23-25 weeks gestation
Measured via Actigraph accelerometer
Physical activity level (objective)
Time frame: 35-37 weeks gestation
Measured via Actigraph accelerometer
Physical activity level (subjective)
Time frame: 6 weeks postpartum
Measured via Exercise Vital Signs (survey)
Physical activity level (objective)
Time frame: 12 weeks postpartum
Measured via Actigraph accelerometer
Physical activity level (subjective)
Time frame: 13-15 weeks gestation
Exercise Vital Sign Survey
Physical activity level (subjective)
Time frame: 23-25 weeks gestation
Exercise Vital Sign Survey
Physical activity level (subjective)
Time frame: 35-37 weeks gestation
Exercise Vital Sign Survey
Physical activity level (subjective)
Time frame: 12 weeks postpartum
Exercise Vital Sign Survey
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Confirmed singleton viable pregnancy
- English-Speaking (the app is currently only available in English)
- Physician release to participate in exercise prior to study participation
- Ownership of a smartphone
- Patient at either Graves Gilbert Clinic or Women's Health Specialists
- Plans to deliver at The Medical Center in Bowling Green, KY.
Exclusion criteria
- Multiple gestation pregnancy
- Inability to provide voluntary informed consent
- Any medical condition (pregnancy-related or not) that would preclude exercise.
Where
- Bowling Green, Kentucky
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 27, 2026 · Source of record for eligibility and locations