Support healthy emotional co-regulation between mothers with PCOS and obesity and their infants
Official title: Strengthening Healthy Emotional Co-regulation of Mothers With PCOS and Obesity and Their Infants
Run by Oulu University Hospital · NCT07129434 · Data updated 2026-11-12
This program will try a brief, multimodal ECoFam intervention to see if it improves emotional connection and reduces depressive symptoms in mothers with PCOS and obesity and their infants.
Quick facts
| Study type | Interventional |
|---|---|
| Sex | Women only |
| Enrollment | 40 (estimated) |
| Sponsor | Oulu University Hospital Academic / other |
| Locations | 1 site (Oulu) |
| Status | Recruiting |
| Started | April 15, 2025 |
| Main results expected | July 2026 |
| Study ends | December 2026 |
| Registry record updated | August 19, 2025 |
| Trial ID | NCT07129434 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are mothers with diagnosed PCOS and obesity who delivered at Oulu University Hospital in 2024–25, participated in the PEPPI cohort, and have a pre-test uWECS score below 9.0.
✕Probably not a fit
Mothers who do not meet the PCOS or obesity criteria, are not PEPPI participants, have higher uWECS scores, or whose infants have died are unlikely to receive benefit from this program.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional feasibility study will recruit mother–infant dyads from the PEPPI cohort who delivered at Oulu University Hospital in 2024–25 and who have a low pre-test uWECS score. Eligible mothers must have a diagnosis of PCOS and meet obesity BMI criteria and will receive the brief, multimodal ECoFam intervention focused on emotional connection and co-regulation. The study will implement the uWECS screening tool in clinical follow-up and measure feasibility outcomes plus limited efficacy on maternal emotional connection, depressive symptoms, and infant socioemotional indicators. If feasible, the protocol and training will be refined for rapid scale-up within Finnish maternal–child services.
Why it matters
Potential benefit: If successful, the intervention could strengthen mother–infant emotional connection and reduce maternal depressive symptoms, improving early family wellbeing.
How similar studies have gone: Prior US studies of related interventions reported large effect sizes (Cohen's d > 0.6) for increasing emotional connection and reducing maternal depressive symptoms, supporting the adapted approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: \- Infant death
Where it's running
-
Oulu University Hospital
Oulu, Finland Recruiting
Study contacts
- Principal investigator: Julia Jäkel, Dr. phil. habil. — University of Oulu
- Study coordinator: Julia Jaekel, PhD
- Email: apfelliebhaber@gmail.com
- Phone: 358458043150
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.