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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07129434
Acronym
ECoFam
Enrollment
40
Registered
2025-08-19
Start date
2025-04-15
Completion date
2026-12-31
Last updated
2025-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity &Amp;Amp; Overweight, Polycystic Ovary Syndrome (PCOS)

Brief 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.

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.

Sponsors

University of Oulu
CollaboratorOTHER
Oulu University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Universal Welch Emotional Connection Screen (uWECS)From enrollment to the end of intervention and follow-up at 4 monthsEmotional connection evaluated with the uWECS

Secondary

MeasureTime frameDescription
Mothers' mental health problemsFrom enrollment to end of intervention and follow-up 4 monthsMothers' mental health problems are assessed with a range of standardized questionnaires using RedCap; higher scores mean worse outcomes.

Countries

Finland

Contacts

Primary ContactJulia Jaekel, PhD
apfelliebhaber@gmail.com358458043150

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026