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NCT Number: NCT06241144

Supporting Lifestyle Changes After Delivery

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

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Oulu University Hospital

Oulu, 90029, Finland

Location status: Recruiting

Location contact

Sanna Mustaniemi, PhD

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Information and communication technology -based health behavior change support system

Device

Information and communication technology -based health behavior change support system addition to conventional postpartum lifestyle education

Primary outcomes

  1. Weight change

    Time frame: 12 months

    Weight change in kilograms and change of body mass index (kg/m^2)

  2. Weight change

    Time frame: 24 months

    Weight change in kilograms and change of body mass index (kg/m^2)

Secondary outcomes

  1. Weight change before subsequent pregnancy

    Time frame: 1-8 years

    Weight change in kilograms and change of body mass index (kg/m^2)

  2. Pregnancy disorders in subsequent pregnancy (gestational diabetes, pre-eclampsia, gestational hypertension, preterm delivery)

    Time frame: 1-8 years

    Number of participants with pregnancy disorders in subsequent pregnancy (gestational diabetes, pre-eclampsia, gestational hypertension, preterm delivery, mortality)

  3. 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

    Number of neonates with adverse neonatal outcome (preterm birth, large for gestational age, small for gestational age, need for neonatal intensive care, mortality)

Study contacts

Contact information is provided by the study sponsor or research team.

Elina Keikkala, PhD

CONTACT

[email protected]

Sanna Mustaniemi, PhD

CONTACT

[email protected]

+358 8669 9500

Sponsors and collaborators

Lead sponsor

Oulu University Hospital

Other

Collaborators

  • University of Oulu

Registry information

Official study title

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

Acronym: STELLA

Important dates

Study start
2024
Primary completion
2026
Study completion
2032
First posted
Feb 5, 2024
Registry last updated
Apr 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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