Polycystic Ovary Syndrome (PCOS)ECoFamNCT07129434
Strengthening Healthy Emotional Co-regulation of Mothers With PCOS and Obesity and Their Infants
A study testing ECoFam in people with Polycystic Ovary Syndrome (PCOS) and Obesity &Amp;Amp; Overweight, run by Oulu University Hospital at 1 site in Finland.
Trial summary
It is both timely and important to invest in interventions that can improve healthy emotional co-regulation. It is proposed to evaluate the feasibility and limited efficacy of an adapted, brief, multimodal intervention: ECoFam (Emotional connection and Co-regulation for Families). Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Polycystic Ovary Syndrome (PCOS), Obesity &Amp;Amp; Overweight
- What is being tested?
- ECoFam
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFinland
- Study dates
- 15 Apr 2025to Dec 2026
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of PCOS
- Obesity according to BMI
- Gave birth at Oulu University Hospital in 2024-25
- PEPPI cohort study participation
- uWECS emotional connection score <9.0 at pre-test
Who cannot join
- Infant death
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Finland1 site, 1 recruiting
- Recruiting
Oulu University Hospital
Oulu
Jaana Nevalainen, MD PhD, 358405801857, Jaana.Nevalainen@oulu.fi
About this study
It is both timely and important to invest in interventions that can improve healthy emotional co-regulation. It is proposed to evaluate the feasibility and limited efficacy of an adapted, brief, multimodal intervention: ECoFam (Emotional connection and Co-regulation for Families). Evidence from the US suggests intervention effects on maternal and infant outcomes that are large in effect size (i.e., Cohen's d >0.6 for increasing emotional connection and decreasing maternal depressive symptoms) (21-23). The study results will directly translate evidence into practice and, if found feasible, allow rapid scaling-up.
Objectives:
- Build capacity for implementation of a novel diagnostic screening tool for emotional co-regulation, the uWECS, as part of clinical follow-up for mother-infant dyads with high fibrobesity risk in Finland.
- Test the feasibility and limited efficacy of the brief, multimodal ECoFam intervention to foster healthy emotional co-regulation between mothers with PCOS and obesity and their infants.
- Being tested
- ECoFam
- Medical subject headings
- Polycystic Ovary Syndrome, Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECoFamBehavioural
Mother-infant dyads randomized into the intervention group receive four personal coaching sessions to facilitate emotional connection via multisensory channels including comfort touch and communication of face-to-face affect during holding time.
| Study group | Role | What they receive |
|---|---|---|
| ECoFam intervention | Experimental | personalized coaching sessions Receives: Behavioral: ECoFam |
| treatment-as-usual (TAU) | No intervention | control group, no intervention administered |
What is being measured
The primary outcome is the main question the study is designed to answer.
Universal Welch Emotional Connection Screen (uWECS)
Emotional connection evaluated with the uWECS
Measured: From enrollment to the end of intervention and follow-up at 4 months
Secondary outcomes (1)
Mothers' mental health problems
Mothers' mental health problems are assessed with a range of standardized questionnaires using RedCap; higher scores mean worse outcomes.
Measured: From enrollment to end of intervention and follow-up 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2025
- Study start15 Apr 2025
- Primary completionJul 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary Syndrome (PCOS)Studies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oulu University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oulu
- Responsible party
- Principal investigator, Julia Jaekel, Oulu University Hospital
- Investigators
- Julia Jäkel, Dr. phil. habil., Principal investigator, University of Oulu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07129434
- Sponsor's protocol ID
- ECoFam PEPPI Pilot RCT
- Acronym
- ECoFam
- Status last verified
- Aug 2025
- First submitted
- 4 Aug 2025
- Last updated
- 19 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strengthening Healthy Emotional Co-regulation of Mothers With PCOS and Obesity and Their Infants
- ClinicalTrials.gov ID
- NCT07129434
- Acronym / sponsor ID
- ECoFam / ECoFam PEPPI Pilot RCT
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Oulu University HospitalUniversity, hospital or other
- Collaborators
- University of Oulu
- Study start
- 15 Apr 2025 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 19 Aug 2025 (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.
It is both timely and important to invest in interventions that can improve healthy emotional co-regulation. It is proposed to evaluate the feasibility and limited efficacy of an adapted, brief, multimodal intervention: ECoFam (Emotional connection and Co-regulation for Families). Evidence from the US suggests intervention effects on maternal and infant outcomes that are large in effect size (i.e., Cohen's d >0.6 for increasing emotional connection and decreasing maternal depressive symptoms) (21-23). The study results will directly translate evidence into practice and, if found feasible, allow rapid scaling-up.
Objectives:
- Build capacity for implementation of a novel diagnostic screening tool for emotional co-regulation, the uWECS, as part of clinical follow-up for mother-infant dyads with high fibrobesity risk in Finland.
- Test the feasibility and limited efficacy of the brief, multimodal ECoFam intervention to foster healthy emotional co-regulation between mothers with PCOS and obesity and their infants.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ECoFam intervention | Experimental | Behavioral: ECoFampersonalized coaching sessions |
| treatment-as-usual (TAU) | No intervention | –control group, no intervention administered |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of PCOS
- Obesity according to BMI
- Gave birth at Oulu University Hospital in 2024-25
- PEPPI cohort study participation
- uWECS emotional connection score <9.0 at pre-test
Key exclusion criteria (1 listed)
- Infant death
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 |
|---|---|---|
| ECoFamMother-infant dyads randomized into the intervention group receive four personal coaching sessions to facilitate emotional connection via multisensory channels including comfort touch and communication of face-to-face affect during holding time. | Behavioural | ECoFam intervention |
Primary outcome
Universal Welch Emotional Connection Screen (uWECS)
Time frame: From enrollment to the end of intervention and follow-up at 4 months
Emotional connection evaluated with the uWECS
1 secondary outcome
Mothers' mental health problems
Time frame: From enrollment to end of intervention and follow-up 4 months
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 19 Aug 2025.
- 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.
Julia Jäkel, Dr. phil. habil. principal investigator
University of Oulu
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ECoFam in people with Polycystic Ovary Syndrome (PCOS) and Obesity &Amp;Amp; Overweight, 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 5 inclusion and 1 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 19 Aug 2025. 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 Julia Jaekel, PhD (358458043150, apfelliebhaber@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Universal Welch Emotional Connection Screen (uWECS) (time frame: From enrollment to the end of intervention and follow-up at 4 months). 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 19 Aug 2025.