Obesity, MaternalSTELLANCT06241144
Supporting Lifestyle Changes After Delivery
A study testing Information and communication technology -based health behavior change support system in people with Obesity, Maternal and Lifestyle, run by Oulu University Hospital at 1 site in Finland.
Trial summary
Use of information and communication technology -based health behavior change support system in modifying lifestyle after delivery among women with obesity. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Obesity, Maternal, Lifestyle
- What is being tested?
- Information and communication technology -based health behavior change support system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFinland
- Study dates
- 9 Feb 2024to 31 Dec 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pre-pregnancy BMI ≥ 30.0 kg/m^2
- Smartphone user
Who cannot join
- Eating disorder
- Severe mental disorder
- Use of other lifestyle support system or medication
- Non-Finnish speaker
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Elina Keikkala, PhD contact
Finland1 site, 1 recruiting
- Recruiting
Oulu University Hospital
Oulu, 90029
Sanna Mustaniemi, PhD
About this study
Official title: Information and Communication Technology -Based Health Behavior Change Support System to Modify Lifestyle After Delivery: Randomized Controlled Intervention Study
Use of information and communication technology -based health behavior change support system in modifying lifestyle after delivery among women with obesity.
Read the 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.
- Conditions
- Obesity, Maternal, Lifestyle
- Being tested
- Information and communication technology -based health behavior change support system
- Medical subject headings
- Pregnancy in Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Information and communication technology -based health behavior change support systemDevice
Information and communication technology -based health behavior change support system addition to conventional postpartum lifestyle education
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Device: Information and communication technology -based health behavior change support system |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight change
Weight change in kilograms and change of body mass index (kg/m^2)
Measured: 12 months
Weight change
Weight change in kilograms and change of body mass index (kg/m^2)
Measured: 24 months
Secondary outcomes (3)
Weight change before subsequent pregnancy
Weight change in kilograms and change of body mass index (kg/m^2)
Measured: 1-8 years
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)
Measured: 1-8 years
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)
Measured: 1-8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start9 Feb 2024
- Primary completion31 Jan 2026 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, MaternalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled study
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oulu University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oulu
- Responsible party
- Principal investigator, Marja Vääräsmäki, Oulu University Hospital
- Investigators
- Marja Vääräsmäki, Professor, Principal investigator, Research Unit of Clinical Medicine, University of Oulu, Oulu University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06241144
- Sponsor's protocol ID
- 39/2023
- Acronym
- STELLA
- Status last verified
- Apr 2024
- First submitted
- 25 Jan 2024
- Last updated
- 3 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Information and Communication Technology -Based Health Behavior Change Support System to Modify Lifestyle After Delivery: Randomized Controlled Intervention Study
- ClinicalTrials.gov ID
- NCT06241144
- Acronym / sponsor ID
- STELLA / 39/2023
- Conditions
- Obesity, Maternal, Lifestyle
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Oulu University HospitalUniversity, hospital or other
- Collaborators
- University of Oulu
- Study start
- 9 Feb 2024 (actual)
- Primary completion
- 31 Jan 2026 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 5 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Information and communication technology -based health behavior change support system |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Pre-pregnancy BMI ≥ 30.0 kg/m^2
- Smartphone user
Key exclusion criteria (4 listed)
- Eating disorder
- Severe mental disorder
- Use of other lifestyle support system or medication
- Non-Finnish speaker
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Information and communication technology -based health behavior change support systemInformation and communication technology -based health behavior change support system addition to conventional postpartum lifestyle education | Device | Intervention |
Primary outcome
Weight change
Time frame: 12 months
Weight change in kilograms and change of body mass index (kg/m^2)
Weight change
Time frame: 24 months
Weight change in kilograms and change of body mass index (kg/m^2)
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2024.
- STELLA project pageLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elina Keikkala, PhD contact
Marja Vääräsmäki, Professor principal investigator
Research Unit of Clinical Medicine, University of Oulu, Oulu University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Information and communication technology -based health behavior change support system in people with Obesity, Maternal and Lifestyle, run by Oulu University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sanna Mustaniemi, PhD (+358 8669 9500, sanna.mustaniemi@oulu.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight change (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2024.