NCT07129434 Strengthening Healthy Emotional Co-regulation of Mothers With PCOS and Obesity and Their Infants
| NCT ID | NCT07129434 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Oulu University Hospital |
| Condition | Polycystic Ovary Syndrome (PCOS) |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-04-15 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2025-04-15 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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). 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: 1. 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. 2. 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.
Eligibility 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
Contact & Investigator
Julia Jäkel, Dr. phil. habil.
PRINCIPAL INVESTIGATOR
University of Oulu
Frequently Asked Questions
Who can join the NCT07129434 clinical trial?
This trial is open to female participants only, studying Polycystic Ovary Syndrome (PCOS). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07129434 currently recruiting?
Yes, NCT07129434 is actively recruiting participants. Contact the research team at apfelliebhaber@gmail.com for enrollment information.
Where is the NCT07129434 trial being conducted?
This trial is being conducted at Oulu, Finland.
Who is sponsoring the NCT07129434 clinical trial?
NCT07129434 is sponsored by Oulu University Hospital. The principal investigator is Julia Jäkel, Dr. phil. habil. at University of Oulu. The trial plans to enroll 40 participants.