Oulu University Hospital
Oulu, 90029, Finland
Location status: Recruiting
Location contact
Sanna Mustaniemi, PhD
CONTACT
NCT Number: NCT06241144
Use of information and communication technology -based health behavior change support system in modifying lifestyle after delivery among women with obesity.
Interested in participating?
Request Info18 year and older
Female
Interventional
Not applicable
Oulu, 90029, Finland
Location status: Recruiting
Sanna Mustaniemi, PhD
CONTACT
Postpartum weight retention is common and particular when accompanied with prior obesity, it further increases the risks of subsequent pregnancies and adverse effects on the long-term health.
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Information and communication technology -based health behavior change support system addition to conventional postpartum lifestyle education
Time frame: 12 months
Weight change in kilograms and change of body mass index (kg/m^2)
Time frame: 24 months
Weight change in kilograms and change of body mass index (kg/m^2)
Time frame: 1-8 years
Weight change in kilograms and change of body mass index (kg/m^2)
Time frame: 1-8 years
Number of participants with pregnancy disorders in subsequent pregnancy (gestational diabetes, pre-eclampsia, gestational hypertension, preterm delivery, mortality)
Time frame: 1-8 years
Number of neonates with adverse neonatal outcome (preterm birth, large for gestational age, small for gestational age, need for neonatal intensive care, mortality)
Contact information is provided by the study sponsor or research team.
Elina Keikkala, PhD
CONTACT
Sanna Mustaniemi, PhD
CONTACT
Oulu University Hospital
Other
Information and Communication Technology -Based Health Behavior Change Support System to Modify Lifestyle After Delivery: Randomized Controlled Intervention Study
Acronym: STELLA
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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