RecruitingNot ApplicableNCT07129434

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


Sponsor

Oulu University Hospital

Enrollment

40 participants

Start Date

Apr 15, 2025

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALE

Plain Language Summary

Simplified for easier understanding

This study is testing a support intervention for new mothers who have both polycystic ovary syndrome (PCOS) and obesity, to help them manage emotions and build a stronger emotional connection with their baby. **You may be eligible if...** - You have been diagnosed with PCOS - You have obesity (based on your BMI) - You gave birth at Oulu University Hospital in 2024 or 2025 - You are enrolled in the PEPPI cohort study - Your emotional connection score (uWECS) was below 9.0 at the initial assessment **You may NOT be eligible if...** - Your infant has passed away Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALECoFam

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.


Locations(1)

Oulu University Hospital

Oulu, Finland

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NCT07129434


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