An interventional study of Information and communication technology -based health behavior change support system in Obesity, Maternal and Lifestyle, sponsored by Oulu University Hospital. Recruiting at 1 site in Finland. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-03.
Sponsored by Oulu University Hospital · Not applicable, Interventional, and Treatment
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Use of information and communication technology -based health behavior change support system in modifying lifestyle after delivery among women with obesity.
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.
60 studies on the registry are indexed under Pregnancy in Obesity; 17 are open to participants now.
This study's planned enrollment of 200 is above the median of 160 across 33 interventional studies indexed under Pregnancy in Obesity.
Browse Pregnancy in Obesity studies →Oulu University Hospital is the lead sponsor of 40 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: 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
Weight change
Weight change in kilograms and change of body mass index (kg/m\^2)
Time frame: 12 months
Weight change
Weight change in kilograms and change of body mass index (kg/m\^2)
Time frame: 24 months
Weight change before subsequent pregnancy
Weight change in kilograms and change of body mass index (kg/m\^2)
Time frame: 1-8 years
Pregnancy disorders in subsequent pregnancy (gestational diabetes, pre-eclampsia, gestational hypertension, preterm delivery)
Number of participants with pregnancy disorders in subsequent pregnancy (gestational diabetes, pre-eclampsia, gestational hypertension, preterm delivery, mortality)
Time frame: 1-8 years
Neonatal outcome in subsequent pregnancy (preterm birth, large for gestational age, small for gestational age, need for neonatal intensive care, mortality)
Number of neonates with adverse neonatal outcome (preterm birth, large for gestational age, small for gestational age, need for neonatal intensive care, mortality)
Time frame: 1-8 years
Plan to share: No
Started Feb 2024 (actual). Primary completion is estimated for Jan 2026, 23 months after the start.
Of 19 interventional studies with no phase under Pregnancy in Obesity, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 26. This study's planned 23 months is close to that.
How these figures are worked out, and which studies are left out of them.
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Oulu University Hospital