Strengthening Healthy Emotional Co-regulation of Mothers With PCOS and Obesity and Their Infants

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.

NCT Number	NCT07129434
Lead Sponsor	Oulu University Hospital Collaborators: University of Oulu
Conditions	Polycystic Ovary Syndrome (PCOS), Obesity & Overweight
Enrollment	40 participants
Start Date	2025-04-15
Primary Completion	2026-07 (estimated)
Study Completion	2026-12 (estimated)
Updated on ClinicalTrials.gov	2025-08-19