NCT07129434

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Oulu University Hospital · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Polycystic Ovary Syndrome (PCOS)
• Obesity &Amp;Amp; Overweight

Interventions

Type	Name	Description
BEHAVIORAL	ECoFam	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.

Timeline

• Start date: 2025-04-15
• Primary completion: 2026-07-01
• Completion: 2026-12-01
• First posted: 2025-08-19
• Last updated: 2025-08-19

Locations

1 site across 1 country: Finland