Supporting Lifestyle Changes After Delivery

Lifestyle Clinical Trial

— STELLA  

Official title:

Information and Communication Technology -Based Health Behavior Change Support System to Modify Lifestyle After Delivery: Randomized Controlled Intervention Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06241144
• Other study ID #: 39/2023
• Status: Recruiting
• Phase: N/A
• Start date: February 9, 2024
• Est. completion date: December 31, 2032

Study information

• Verified date: April 2024
• Source: Oulu University Hospital
• Contact: Sanna Mustaniemi, PhD
• Phone: +358 8669 9500
• Email: sanna.mustaniemi[@]oulu.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Use of information and communication technology -based health behavior change support system in modifying lifestyle after delivery among women with obesity.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2032
• Est. primary completion date: January 31, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Pre-pregnancy BMI = 30.0 kg/m^2
• Smartphone user

Exclusion Criteria:

• Eating disorder
• Severe mental disorder
• Use of other lifestyle support system or medication
• Non-Finnish speaker

Related Conditions & MeSH terms

• Lifestyle

Intervention

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

Locations

Country	Name	City	State
Finland	Oulu University Hospital	Oulu

Sponsors (2)

Lead Sponsor	Collaborator
Oulu University Hospital	University of Oulu

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight change	Weight change in kilograms and change of body mass index (kg/m^2)	12 months
Primary	Weight change	Weight change in kilograms and change of body mass index (kg/m^2)	24 months
Secondary	Weight change before subsequent pregnancy	Weight change in kilograms and change of body mass index (kg/m^2)	1-8 years
Secondary	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)	1-8 years
Secondary	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)	1-8 years

External Links

•   STELLA project page