Clinical trial

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

Recruiting now · Not applicable · 1 countries · Registry ID NCT07129434

Recruiting nowNot applicableInterventional

What this study 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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

AgeNot listed to Not listed
SexFemale
Healthy volunteersNot accepted
ConditionPolycystic Ovary Syndrome (PCOS), Obesity &Amp;Amp; Overweight

Full registry criteria

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 and study arms

ECoFam

Behavioral

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.

Primary outcomes

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

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Oulu University Hospital🇫🇮 Oulu, Finland
Jaana Nevalainen, MD PhDContact