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i2be: a randomized controlled trial protocol for an app-based physical activity intervention

i2be: a randomized controlled trial protocol for a multicomponent app-based physical activity intervention in women with a prior hypertensive disorder of pregnancy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON28866
Enrollment
600
Registered
2021-03-09
Start date
2021-09-06
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None

Interventions

Intervention duration is 8 weeks. All participants use the i2be app and their Fitbit device, and receive the module ‘Get Informed’ consisting of usual care (standard treatment). In addition to receiv

Sponsors

Smarter Choices for Better Health Erasmus Initiative (Erasmus University Rotterdam)
Lead Sponsor

Eligibility

Inclusion criteria

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: 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.

Design outcomes

Primary

MeasureTime frame
The primary outcome is objectively measured weekly minutes of moderate-to-vigorous physical activity.

Secondary

MeasureTime frame
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.

Contacts

Public ContactLili Kókai

Erasmus MC

l.kokai@erasmusmc.nl0649267173

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)