Clinical trial NCT06241144: Supporting Lifestyle Changes After Delivery
Official title: Information and Communication Technology -Based Health Behavior Change Support System to Modify Lifestyle After Delivery: Randomized Controlled Intervention Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity, Maternal
Lifestyle
Lead sponsor: Oulu University Hospital
Sponsor class: OTHER
Collaborators: name: University of Oulu
First posted: 2024-02-05
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled study
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Weight change
timeFrame: 12 months
measure: Weight change
timeFrame: 24 months
Secondary outcomes:
measure: Weight change before subsequent pregnancy
timeFrame: 1-8 years
measure: Pregnancy disorders in subsequent pregnancy (gestational diabetes, pre-eclampsia, gestational hypertension, preterm delivery)
timeFrame: 1-8 years
measure: Neonatal outcome in subsequent pregnancy (preterm birth, large for gestational age, small for gestational age, need for neonatal intensive care, mortality)
timeFrame: 1-8 years
Other outcomes:
Locations:
city: Oulu
country: Finland
facility: Oulu University Hospital
Study officials:
affiliation: Research Unit of Clinical Medicine, University of Oulu, Oulu University Hospital
name: Marja Vääräsmäki, Professor
role: PRINCIPAL_INVESTIGATOR
References: