NCT05849649 Mobile Application-based Exercise Intervention for Pregnant Women
| NCT ID | NCT05849649 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Western Kentucky University |
| Condition | Pregnancy Related |
| Study Type | INTERVENTIONAL |
| Enrollment | 176 participants |
| Start Date | 2023-08-01 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 176 participants in total. It began in 2023-08-01 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Age 18-44 * 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.
Contact & Investigator
Rachel A Tinius, PhD
PRINCIPAL INVESTIGATOR
Western Kentucky University
Frequently Asked Questions
Who can join the NCT05849649 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 44 Years, studying Pregnancy Related. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05849649 currently recruiting?
Yes, NCT05849649 is actively recruiting participants. Contact the research team at rachel.tinius@wku.edu for enrollment information.
Where is the NCT05849649 trial being conducted?
This trial is being conducted at Bowling Green, United States.
Who is sponsoring the NCT05849649 clinical trial?
NCT05849649 is sponsored by Western Kentucky University. The principal investigator is Rachel A Tinius, PhD at Western Kentucky University. The trial plans to enroll 176 participants.