Strengthening Healthy Emotional Co-regulation of Mothers With PCOS and Obesity and Their Infants
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ECoFam.
- Who it may be relevant to
- Registry conditions: Polycystic Ovary Syndrome (PCOS), Obesity &Amp;Amp; Overweight. Basic parameters: No limits · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Finland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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.
Primary outcome measures
- Universal Welch Emotional Connection Screen (uWECS) [Time frame: From enrollment to the end of intervention and follow-up at 4 months]
Secondary outcome measures (1)
- Mothers' mental health problems [Time frame: From enrollment to end of intervention and follow-up 4 months]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Single group
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
Finland · 1 center
- Oulu University Hospital — Oulu
Identifiers
NCT: NCT07129434 · ECoFam PEPPI Pilot RCT