Polycystic Ovary Syndrome (PCOS)ECoFamNCT07129434
Strengthening Healthy Emotional Co-regulation of Mothers With PCOS and Obesity and Their Infants
A study testing ECoFam in people with Polycystic Ovary Syndrome (PCOS) and Obesity &Amp;Amp; Overweight, run by Oulu University Hospital at 1 site in Finland.
Trial 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). Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Polycystic Ovary Syndrome (PCOS), Obesity &Amp;Amp; Overweight
- What is being tested?
- ECoFam
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFinland
- Study dates
- 15 Apr 2025to Dec 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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 join
- Infant death
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Finland1 site, 1 recruiting
- Recruiting
Oulu University Hospital
Oulu
Jaana Nevalainen, MD PhD, 358405801857, Jaana.Nevalainen@oulu.fi
About this study
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:
- 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.
- 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.
- Being tested
- ECoFam
- Medical subject headings
- Polycystic Ovary Syndrome, Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECoFamBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| ECoFam intervention | Experimental | personalized coaching sessions Receives: Behavioral: ECoFam |
| treatment-as-usual (TAU) | No intervention | control group, no intervention administered |
What is being measured
The primary outcome is the main question the study is designed to answer.
Universal Welch Emotional Connection Screen (uWECS)
Emotional connection evaluated with the uWECS
Measured: From enrollment to the end of intervention and follow-up at 4 months
Secondary outcomes (1)
Mothers' mental health problems
Mothers' mental health problems are assessed with a range of standardized questionnaires using RedCap; higher scores mean worse outcomes.
Measured: From enrollment to end of intervention and follow-up 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2025
- Study start15 Apr 2025
- Primary completionJul 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary Syndrome (PCOS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oulu University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oulu
- Responsible party
- Principal investigator, Julia Jaekel, Oulu University Hospital
- Investigators
- Julia Jäkel, Dr. phil. habil., Principal investigator, University of Oulu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07129434
- Sponsor's protocol ID
- ECoFam PEPPI Pilot RCT
- Acronym
- ECoFam
- Status last verified
- Aug 2025
- First submitted
- 4 Aug 2025
- Last updated
- 19 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No