Actively Recruiting

Phase Not Applicable
FEMALE
NCT07129434

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

Led by Oulu University Hospital · Updated on 2025-08-19

40

Participants Needed

1

Research Sites

85 weeks

Total Duration

On this page

Sponsors

O

Oulu University Hospital

Lead Sponsor

U

University of Oulu

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of PCOS
  • Obesity according to BMI
  • Gave birth at Oulu University Hospital in 2024-25
  • Participated in PEPPI cohort study
  • uWECS emotional connection score below 9.0 at pre-test
Not Eligible

You will not qualify if you...

  • Infant death

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Oulu University Hospital

Oulu, Finland

Actively Recruiting

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Research Team

J

Julia Jaekel, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

PREVENTION

Number of Arms

2

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