Supporting Lifestyle Changes After Delivery

Not Applicable

Recruiting

• Conditions: Obesity, Maternal; Lifestyle
• Interventions: Device: Information and communication technology -based health behavior change support system

• Registration Number: NCT06241144
• Lead Sponsor: Oulu University Hospital

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2024-01-25
• Study First Submitted QC: 2024-02-02
• Study First Posted: 2024-02-05
• Study Start: 2024-02-09
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-01
• Last Update Posted: 2024-04-03
• Primary Completion: 2026-01-31
• Study Completion: 2032-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Information and communication technology -based health behavior change support system	-

Primary Outcome Measures

Name	Time	Method
Weight change	24 months	Weight change in kilograms and change of body mass index (kg/m\^2)

Secondary Outcome Measures

Name	Time	Method
Neonatal outcome in subsequent pregnancy (preterm birth, large for gestational age, small for gestational age, need for neonatal intensive care, mortality)	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)
Weight change before subsequent pregnancy	1-8 years	Weight change in kilograms and change of body mass index (kg/m\^2)
Pregnancy disorders in subsequent pregnancy (gestational diabetes, pre-eclampsia, gestational hypertension, preterm delivery)	1-8 years	Number of participants with pregnancy disorders in subsequent pregnancy (gestational diabetes, pre-eclampsia, gestational hypertension, preterm delivery, mortality)

Trial Locations

Locations (1)

Oulu University Hospital; 🇫🇮 Oulu, Finland