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NCT07129434Recruiting

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

Source: ClinicalTrials.gov · Last updated 19 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
40 (estimated)
First submitted
4 Aug 2025
Start date
15 Apr 2025
Primary completion date
Jul 2026
Lead sponsor
Oulu University Hospital
Diseases
Obesity
NCT number
NCT07129434

What you commit to

  • Study type: Interventional
  • Planned participants: 40
  • From 15 Apr 2025 to the primary completion date, Jul 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • \- Infant death

Who the study is looking for

  • 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

Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

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SiteCityCountrySite status
Oulu University Hospital
Coordinator of this site? Confirm its status
OuluFinlandRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.