RECRUITING

Mobile Application-based Exercise Intervention for Pregnant Women

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Increasing Physical Activity Through a Mobile Health Intervention Among Pregnant and Postpartum Women in a Rural Setting

Quick Facts

Study Start:2023-08-01
Study Completion:2026-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05849649

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 44 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 18-44
  2. * Confirmed singleton viable pregnancy
  3. * English-Speaking (the app is currently only available in English)
  4. * Physician release to participate in exercise prior to study participation
  5. * Ownership of a smartphone
  6. * Patient at either Graves Gilbert Clinic or Women's Health Specialists
  7. * Plans to deliver at The Medical Center in Bowling Green, KY.
  1. * Multiple gestation pregnancy
  2. * Inability to provide voluntary informed consent
  3. * Any medical condition (pregnancy-related or not) that would preclude exercise.

Contacts and Locations

Study Contact

Rachel A Tinius, PhD
CONTACT
2707455026
rachel.tinius@wku.edu

Principal Investigator

Rachel A Tinius, PhD
PRINCIPAL_INVESTIGATOR
Western Kentucky University

Study Locations (Sites)

Rachel Tinius
Bowling Green, Kentucky, 42101
United States

Collaborators and Investigators

Sponsor: Western Kentucky University

  • Rachel A Tinius, PhD, PRINCIPAL_INVESTIGATOR, Western Kentucky University

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

Study Start Date2023-08-01
Study Completion Date2026-06-30

Study Record Updates

Study Start Date2023-08-01
Study Completion Date2026-06-30

Terms related to this study

Keywords Provided by Researchers

  • exercise
  • mHealth
  • pregnancy
  • postpartum
  • rural

Additional Relevant MeSH Terms

  • Pregnancy Related
  • Postpartum