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Recruiting NCT06241144

Supporting Lifestyle Changes After Delivery

No phase Interventional Obesity, Maternal Lifestyle

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Information and communication technology -based health behavior change support system.
Who it may be relevant to
Registry conditions: Obesity, Maternal, Lifestyle. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Finland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • 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

Primary outcome measures

  • Weight change [Time frame: 12 months]
  • Weight change [Time frame: 24 months]
Secondary outcome measures (3)
  • Weight change before subsequent pregnancy [Time frame: 1-8 years]
  • Pregnancy disorders in subsequent pregnancy (gestational diabetes, pre-eclampsia, gestational hypertension, preterm delivery) [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) [Time frame: 1-8 years]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Finland · 1 center
  • Oulu University Hospital — Oulu

Identifiers

NCT: NCT06241144 · 39/2023

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗