NCT07166822

Brief Summary

The goal of this study is to determine the effectiveness of a mobile exercise app in improving cardiovascular health and motivation to exercise in pregnant women who are healthy, in their 2nd trimester, between 18-45 years age, and do not do exercise currently. The aims of this study are determine i) the effect of a mobile app (BumptUp) to increase motivation to exercise as assessed by questionnaire, and ii) the changes may occur in cardiovascular health outcomes such as increased percent Flow-Mediated Dilation (FMD), Heart Rate Variability (HRV), and decreased Pulse Wave Velocity (PWV) over an 8-week period of intervention. Researchers will compare this to pregnant women who are healthy, in their 2nd trimester, between 18-45 years age, and who will not be using the mobile app (BumptUp) for exercise. Participants who are in the experimental group will be given access to the mobile app (BumptUp) for 8 weeks. Both the control and experimental group will visit the lab for their baseline measurements (study visit 1), followed by two visits at 4 weeks (study visit 2) and 8 weeks (study visit 3) to have their heart rate variability, arterial stiffness (PWV), and vascular function (FMD) assessed. At each study visit, blood pressure, heart rate, height, and weight will also be measured. Additionally, at all three study visits, participants will fill out a questionnaire to determine motivation to exercise.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
26mo left

Started Sep 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress26%
Sep 2025Aug 2028

First Submitted

Initial submission to the registry

August 27, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 10, 2025

Completed
5 days until next milestone

Study Start

First participant enrolled

September 15, 2025

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2028

Last Updated

September 10, 2025

Status Verified

September 1, 2025

Enrollment Period

1.9 years

First QC Date

August 27, 2025

Last Update Submit

September 3, 2025

Conditions

Keywords

pregnantcardiovascularmobile appexercise

Outcome Measures

Primary Outcomes (1)

  • Flow mediated dilation

    The cardiovascular health via flow mediated dilation (% change from baseline) will be assessed

    8 weeks of intervention period

Secondary Outcomes (1)

  • Arterial stiffness

    8 weeks

Other Outcomes (2)

  • Heart rate variability

    8 weeks

  • motivation to exercise

    8 weeks

Study Arms (2)

Experimental arm who will use the BumptUp mobile exercise app

EXPERIMENTAL

This group will have access to "BumptUp" mobile exercise app and will be provided with an educational brochure (Exercise during pregnancy)

Behavioral: Experimental group using BumptUp mobile exercise app

Control group

NO INTERVENTION

This group will have no access to "BumptUp" mobile exercise app and will only be provided with an educational brochure (Exercise during pregnancy)

Interventions

This BumptUp app has been developed specifically for pregnancy with safety and screening feature. This intervention will be unique since the researchers will evaluate the cardiovascular health outcomes following the 8 weeks of intervention.

Also known as: BumptUp app
Experimental arm who will use the BumptUp mobile exercise app

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOnly pregnant women will be recruited
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age: 18-45 years.
  • Pregnant women who are 20-24 weeks pregnant at enrollment
  • Sedentary, as defined by completing less than 90 minutes of exercise each week.
  • Generally healthy, uncomplicated pregnancies.
  • Free of physical limitations that may interfere with alterations in daily physical activity levels.
  • Single gestation.
  • Have a smartphone
  • Under the routine medical care of an obstetrician or certified nurse midwife during their current pregnancy.
  • Women speaking English.

You may not qualify if:

  • Physician diagnosed cardiovascular/ vascular complications (heart disease, high blood pressure, Raynaud's phenomenon etc.)
  • Physician diagnosed metabolic diseases (diabetes, hypothyroidism)
  • Musculoskeletal injuries (broken bones, back pain, ankle sprain, muscle pull, etc.)
  • Medications that may impact blood vessel function such as hypertension medication (Angiotensin converting enzyme inhibitor, Angiotensin receptor blocker, Calcium channel blocker, beta blocker), lipid lowering agents (statins), Nitrates, steroids, etc.
  • Complications associated with pregnancy that would be exacerbated by exercise such as lung disease, persistent spotting/bleeding or Placental Previa, premature labor, ruptured membranes, evidence of intrauterine growth restriction, pregnancy induced hypertension or pre-eclampsia, uncontrolled epileptic fits/seizures.
  • Smoking within the previous 3 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Old Dominion University

Norfolk, Virginia, 23529, United States

RECRUITING

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Principal Investigator, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 27, 2025

First Posted

September 10, 2025

Study Start

September 15, 2025

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 1, 2028

Last Updated

September 10, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations