Tests a brief parent-infant program for mothers with PCOS and obesity
Tests a short program helping mothers with PCOS and obesity bond emotionally with infants.
Key facts
- Who runs it
- Oulu University Hospital
- Where
- Oulu, FinlandSee the site
- Trial code
- Registry title
- Strengthening Healthy Emotional Co-regulation of Mothers With PCOS and Obesity and Their Infants
- Status
- Recruiting
- People taking part
- 40 people, planned
- Started
- 15 Apr 2025
- Expected to end
- Dec 2026
- Type of study
- Interventional, 2 groupsOne group gets no study treatment, for comparison.
- Treatments tested
- ECoFam
- Record updated
- 19 August 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for mothers with PCOS and obesity who gave birth at Oulu University Hospital in 2024-25 and have a low emotional connection score with their infant.
- Sex
- Women only
- Disease stage
- Diagnosis of PCOS and obesity according to BMI
- Biomarker or test result
- uWECS emotional connection score below 9.0 at the first test
Main reasons for not taking part
- Infant death
The registry criteria, word for word
Show all 6 criteriaShow less
Who can take part
- 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
Who cannot take part
- Infant death
Where in Finland
- Oulu University HospitalOulu, FinlandContact: Jaana Nevalainen, MD PhDTaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The 2 groups in the trial
- ECoFam interventionTreatment being tested
personalized coaching sessions
Treatment: ECoFam
- treatment-as-usual (TAU)No study treatment, for comparison
control group, no intervention administered
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Strengthening Healthy Emotional Co-regulation of Mothers With PCOS and Obesity and Their Infants
- Plain-language title
- Tests a brief parent-infant program for mothers with PCOS and obesityGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 19 August 2025