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RECRUITINGINTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: \- Infant death Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

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.

Locations (1)

Oulu University Hospital
Oulu, Finland