Mobile Application-based Exercise Intervention for Pregnant Women
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.
Conditions:
🦠 Pregnancy Related 🦠 Postpartum
🗓️ Study Start (Actual) 1 August 2023
🗓️ Primary Completion (Estimated) 30 June 2026
✅ Study Completion (Estimated) 30 June 2026
👥 Enrollment (Estimated) 176
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Bowling Green, Kentucky, United States

📋 Eligibility Criteria

Description

    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.
Ages Eligible for Study: 18 Years to 44 Years (ADULT)
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 29 March 2023
  • First Submitted that Met QC Criteria 27 April 2023
  • First Posted 9 May 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 30 November 2023
  • Last Update Posted 8 December 2023
  • Last Verified November 2023