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

Oulu University Hospital

Status: Enrolling

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

Treatments: Behavioral: ECoFam

Study type: Interventional

Funder types: Other

Identifiers

NCT07129434

ECoFam PEPPI Pilot RCT

Details and patient eligibility

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.

Enrollment: 40 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

---

40 participants in 2 patient groups

ECoFam intervention

Experimental group

Description:

personalized coaching sessions

Treatment:

Behavioral: ECoFam

treatment-as-usual (TAU)

No Intervention group

Description:

control group, no intervention administered