Pilot Testing a Mobile App to Designed to Increase Physical Activity Among Pregnant and Postpartum Women

NCT04480931 | Completed

• 1 other identifier: 20-257
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this pilot project is to test the feasibility and potential efficacy of the evidence-based mHealth app (BumptUp) for improving physical activity and subsequent health outcomes (i.e. obesity, hypertension, insulin resistance) among pregnant and postpartum women in a rural community. In order to accomplish this goal, feasibility of the intervention protocol will be tested by the assessment of recruitment (how many participants eligible per month), retention (% of women who complete the study protocol), adherence to intervention (% of women who utilize the app), and acceptability (survey and one-on-one exit interviews) during pregnancy and postpartum. Potential efficacy will be determined by examining trends in data on physical activity levels (achieving the goal of 150 minutes per week of physical activity (surveys and accelerometry)) between groups. Other secondary outcomes will also be assessed: weight status, body composition, blood pressure, insulin resistance, fitness levels, mental health, and infant anthropometrics. Clinical hypotheses:

1. 1.The mHealth program will be feasible as evidenced by high rates of enrollment, retention, and adherence, moderate-to-high levels of satisfaction, and low participant burden.
2. 2.The mHealth intervention will show promise towards improving physical activity levels and other secondary outcomes in pregnant and postpartum women in a rural community.

Conditions

Pregnancy; Postpartum

Keywords

exercise; physical activity; mobile health; intervention

Outcome Measures

Primary Outcomes (9)

• Recruitment feasibility during pregnancy

  how many participants eligible and successfully recruited per month

  Pregnancy (23-25 weeks gestation)

• Protocol retention

  % of women who complete the study protocol

  12 weeks postpartum

• Adherence to intervention

  % of women who use the app daily

  Pregnancy (35-37 weeks pregnant)

• Adherence to intervention

  % of women who use the app daily

  Postpartum (12 weeks after delivery)

• Acceptability of Intervention

  measured via exit interviews

  Postpartum (12 weeks after delivery)

• Physical activity levels

  Assess the potential efficacy of the intervention by examining physical activity levels through objective actigraph data

  Pregnancy (23-25 weeks gestation)

• Physical activity levels

  Assess the potential efficacy of the intervention by examining physical activity levels through objective actigraph data

  Pregnancy (35-37 weeks gestation)

• Physical activity levels

  Assess the potential efficacy of the intervention by examining physical activity levels through objective actigraph data

  Postpartum (12 weeks)

• Physical activity levels

  Assess the potential efficacy of the intervention by examining physical activity levels through Exercise Vital Sign Survey

  Postpartum (6 weeks)

Secondary Outcomes (18)

• Maternal weight status

  Pregnancy (23-25 weeks gestation)

• Maternal weight status

  Pregnancy (35-37 weeks gestation)

• Maternal weight status

  Postpartum (12 weeks post-delivery)

• Maternal blood pressure

  Pregnancy (23-25 weeks gestation)

• Maternal blood pressure

  Pregnancy (35-37 weeks gestation)

Study Arms (2)

mHealth Intervention Group

EXPERIMENTAL

This group will be provided with the mobile health app (including introductory videos on how to use its features).

Behavioral: mHealth Intervention Group

Control Group

SHAM COMPARATOR

This group will receive an educational brochure about physical activity during pregnancy.

Behavioral: Educational Brochure

Interventions

mHealth Intervention Group BEHAVIORAL

Access to the mobile health application with exercise plans and education

mHealth Intervention Group

Educational Brochure BEHAVIORAL

An evidence-based educational brochure with general information about the benefits of physical activity during pregnancy

Control Group

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
• \) Ownership of a smart phone
• \) 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
• University of Kentucky: collaborator

Study Sites (1)

Western Kentucky University

Bowling Green, Kentucky, 42101, United States

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The participant (as well as the study team and the health care provider) will know after randomization whether or not they are being provided access to the mobile app.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Pregnant women will be recruited \~20 weeks pregnant and after baseline assessments, randomized into the control or intervention group. The intervention group will utilize the mhealth intervention, while the control group will receive basic educational materials only.

Study Record Dates

• First Submitted: July 8, 2020
• First Posted: July 22, 2020
• Study Start: November 28, 2020
• Primary Completion: December 20, 2021
• Study Completion: May 1, 2022
• Last Updated: July 13, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)