Mobile Application-based Exercise Intervention for Pregnant Women
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-44
SponsorWestern Kentucky University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Multiple gestation pregnancy
Inability to provide voluntary informed consent
Any medical condition (pregnancy-related or not) that would preclude exercise.
Trial design
Design model
Parallel
Treatments tested in this trial
BumptUp
BehavioralThe app contains a number of evidence-based, expertly designed features to help women with healthier lifestyle habits during and after pregnancy.
Educational Brochure
BehavioralAn evidence-based brochure on physical activity
Treatment groups
176 Participants
are divided into 2 treatment groupsGroup A: BumptUp Mobile AppExperimental treatment 1 intervention
Group B: Educational Brochure/ Attention ControlActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Physical activity level (objective)
Measured via Actigraph accelerators
Time frame
13-15 weeks gestation2
Physical activity level (objective)
Measured via Actigraph accelerometer
Time frame
23-25 weeks gestation3
Physical activity level (objective)
Measured via Actigraph accelerometer
Time frame
35-37 weeks gestation4
Physical activity level (subjective)
Measured via Exercise Vital Signs (survey)
Time frame
6 weeks postpartumSecondary outcomes
1
Maternal Weight Status
Measured via objective medical chart data on maternal weight
Time frame
13-15 weeks gestation2
Maternal Weight Status
Measured via objective medical chart data on maternal weight
Time frame
23- 25 weeks gestation3
Maternal Weight Status
Measured via objective medical chart data on maternal weight
Time frame
35-37 weeks gestation4
Maternal Weight Status
Measured via objective medical chart data on maternal weight
Time frame
6 weeks postpartumSponsors and contacts
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Source ClinicalTrials.gov