i2be: a randomized controlled trial protocol for an app-based physical activity interventio
- Conditions
- one
- Registration Number
- NL-OMON28866
- Lead Sponsor
- Smarter Choices for Better Health Erasmus Initiative (Erasmus University Rotterdam)
- Brief Summary
Study protocol will be submitted to a scientific journal.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 600
Inclusion Criteria
In order to be eligible for participation in the trial, a participant must have experienced a hypertensive disorder of pregnancy (e.g. preeclampsia, eclampsia, HELLP syndrome) in the past.
Exclusion Criteria
Exclusion criteria for enrollment into the trial are: <18 years of age, pregnant at time of inclusion, <3 months post-partum, physical limitation preventing physical activity (e.g. illness, injury, surgery, rehabilitation), no working knowledge of Dutch or English language, no possession of a smartphone, and unwillingness to use a Fitbit device and the Fitbit and i2be apps.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome is objectively measured weekly minutes of moderate-to-vigorous physical activity.
- Secondary Outcome Measures
Name Time Method Secondary outcomes include objectively measured (resting) heart rate and self-reported physiology measurements (body mass index, waist-hip-ratio, cardiorespiratory fitness), as well as subjective well-being.