Support healthy emotional co-regulation between mothers with PCOS and obesity and their infants
Strengthening Healthy Emotional Co-regulation of Mothers With PCOS and Obesity and Their Infants
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Sex | Female |
| Sponsor | Oulu University Hospital Academic / other |
| Locations | 1 site (Oulu) |
| Trial ID | NCT07129434 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Oulu
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.