Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
200 participants
INTERVENTIONAL
2024-02-09
2032-12-31
Brief Summary
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Detailed Description
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The aim of this randomized controlled trial is to examine whether using an information and communication technology (ICT) -based health behavior change support system (HBCSS) reduce postpartum weight retention and disorders related to subsequent pregnancy. Web-based HBCSS application utilizes persuasive design and cognitive behavioral therapy.
200 participants with prepregnancy obesity (BMI ≥ 30.0 kg/m\^2) and age ≥ 18 years are randomly assigned into two groups after delivery in the Oulu university hospital. The study period begins 5-12 weeks after delivery. All participants will have conventional postpartum lifestyle counselling and the intervention group get in addition access for 12 months to web-based HBCSS application, which is recommended to use twice a week for 5-10 minutes.
Participants are followed by questionnaires up to 24 months. The main outcome is weight change from baseline to 12 and 24 months. Medical records and national registers are used for long-term follow-up. Researchers have permission to contact participants afterwards. The ethical approval is permitted by the Regional Medical Research Ethics Committee of the Wellbeing Services County of North Ostrobothnia. The authorization for the use of medical device is granted from the Finnish Medicines Agency. Recruitment of the participants will be performed 2/2024-1/2026.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Intervention
Information and communication technology -based health behavior change support system
Information and communication technology -based health behavior change support system addition to conventional postpartum lifestyle education
Control
No interventions assigned to this group
Interventions
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Information and communication technology -based health behavior change support system
Information and communication technology -based health behavior change support system addition to conventional postpartum lifestyle education
Eligibility Criteria
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Inclusion Criteria
* Smartphone user
Exclusion Criteria
* Severe mental disorder
* Use of other lifestyle support system or medication
* Non-Finnish speaker
18 Years
FEMALE
No
Sponsors
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University of Oulu
OTHER
Oulu University Hospital
OTHER
Responsible Party
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Marja Vääräsmäki
Professor
Principal Investigators
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Marja Vääräsmäki, Professor
Role: PRINCIPAL_INVESTIGATOR
Research Unit of Clinical Medicine, University of Oulu, Oulu University Hospital
Locations
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Oulu University Hospital
Oulu, , Finland
Countries
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Central Contacts
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Facility Contacts
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Sanna Mustaniemi, PhD
Role: primary
Related Links
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STELLA project page
Other Identifiers
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39/2023
Identifier Type: -
Identifier Source: org_study_id
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