Recruiting

Exercise Intervention

Sponsor:

Western Kentucky University

Code:

NCT05849649

Conditions

Pregnancy Related

Postpartum

Eligibility Criteria

Sex: Female

Age: 18 - 44

Healthy Volunteers: Accepted

Interventions

BumptUp

Educational Brochure

Study Details

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 BumptUpĀ® 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 ID

NCT05849649

Start date

Aug 1, 2023

Status verified date

Feb, 2026

Completion date

Jun 30, 2026

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 44

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

176 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: BumptUp Mobile App

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.

active comparator: Educational Brochure/ Attention Control

This group will receive evidence-based exercise education the form a one-time brochure.

Interventions

BumptUp

The app contains a number of evidence-based, expertly designed features to help women with healthier lifestyle habits during and after pregnancy.

Educational Brochure

An evidence-based brochure on physical activity

Primary outcome measure

  • Physical activity level (objective) [ Time Frame: 13-15 weeks gestation ]
  • Physical activity level (objective) [ Time Frame: 23-25 weeks gestation ]
  • Physical activity level (objective) [ Time Frame: 35-37 weeks gestation ]
  • Physical activity level (subjective) [ Time Frame: 6 weeks postpartum ]
  • Physical activity level (objective) [ Time Frame: 12 weeks postpartum ]
  • Physical activity level (subjective) [ Time Frame: 13-15 weeks gestation ]
  • Physical activity level (subjective) [ Time Frame: 23-25 weeks gestation ]
  • Physical activity level (subjective) [ Time Frame: 35-37 weeks gestation ]
  • Physical activity level (subjective) [ Time Frame: 12 weeks postpartum ]

Central Contacts and Locations

Central contacts

Locations

Rachel Tinius

Recruiting

Bowling Green, Kentucky, United States, 42101

Contacts

More Information

Sponsor

Western Kentucky University

Last update posted

Feb 27, 2026

Last verified

Feb, 2026

Keywords

  • exercise
  • mHealth
  • pregnancy
  • postpartum
  • rural

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Western Kentucky University on 2026-02-27.