Mobile Application-based Exercise Intervention for Pregnant Women

NCT05849649 | Recruiting DMC

• 1 other identifier: IRB 20-257
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 1

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.

Conditions

Postpartum; Pregnancy Related

Keywords

exercise; mHealth; pregnancy; postpartum; rural

Outcome Measures

Primary Outcomes (9)

• Physical activity level (objective)

  Measured via Actigraph accelerators

  13-15 weeks gestation

• Physical activity level (objective)

  Measured via Actigraph accelerometer

  23-25 weeks gestation

• Physical activity level (objective)

  Measured via Actigraph accelerometer

  35-37 weeks gestation

• Physical activity level (subjective)

  Measured via Exercise Vital Signs (survey)

  6 weeks postpartum

• Physical activity level (objective)

  Measured via Actigraph accelerometer

  12 weeks postpartum

• Physical activity level (subjective)

  Exercise Vital Sign Survey

  13-15 weeks gestation

• Physical activity level (subjective)

  Exercise Vital Sign Survey

  23-25 weeks gestation

• Physical activity level (subjective)

  Exercise Vital Sign Survey

  35-37 weeks gestation

• Physical activity level (subjective)

  Exercise Vital Sign Survey

  12 weeks postpartum

Secondary Outcomes (27)

• Maternal Weight Status

  13-15 weeks gestation

• Maternal Weight Status

  23- 25 weeks gestation

• Maternal Weight Status

  35-37 weeks gestation

• Maternal Weight Status

  6 weeks postpartum

• Maternal Weight Status

  12 weeks postpartum

Study Arms (2)

BumptUp Mobile App

EXPERIMENTAL

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.

Behavioral: BumptUp

Educational Brochure/ Attention Control

ACTIVE COMPARATOR

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

Behavioral: Educational Brochure

Interventions

BumptUp BEHAVIORAL

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

BumptUp Mobile App

Educational Brochure BEHAVIORAL

An evidence-based brochure on physical activity

Educational Brochure/ Attention Control

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Multiple gestation pregnancy
• Inability to provide voluntary informed consent
• Any medical condition (pregnancy-related or not) that would preclude exercise.

Sponsors & Collaborators

• Western Kentucky University: lead

Study Sites (1)

Rachel Tinius

Bowling Green, Kentucky, 42101, United States

RECRUITING

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Rachel A Tinius, PhD

  Western Kentucky University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rachel A Tinius, PhD

CONTACT

2707455026; rachel.tinius@wku.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2023
• First Posted: May 9, 2023
• Study Start: August 1, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)