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

Not Applicable

Recruiting

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

• Registration Number: NCT07129434
• Lead Sponsor: Oulu University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-04-15
• Status Verified: 2025-08
• Study First Submitted: 2025-08-04
• Study First Submitted QC: 2025-08-11
• Last Update Submitted: 2025-08-11
• Study First Posted: 2025-08-19
• Last Update Posted: 2025-08-19
• Primary Completion: 2026-07
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Universal Welch Emotional Connection Screen (uWECS)	From enrollment to the end of intervention and follow-up at 4 months	Emotional connection evaluated with the uWECS

Secondary Outcome Measures

Name	Time	Method
Mothers' mental health problems	From enrollment to end of intervention and follow-up 4 months	Mothers' mental health problems are assessed with a range of standardized questionnaires using RedCap; higher scores mean worse outcomes.

Trial Locations

Locations (1)

Oulu University Hospital; 🇫🇮 Oulu, Finland