Clinical trial · Interventional
Strengthening Healthy Emotional Co-regulation of Mothers With PCOS and Obesity and Their Infants
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Obesity &Amp;Amp; Overweight | — | UNRESOLVED | — |
| Polycystic Ovary Syndrome (PCOS) | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ECoFam | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ECoFam intervention
- description
- personalized coaching sessions
- interventionNames
- Behavioral: ECoFam
- type
- NO_INTERVENTION
- label
- treatment-as-usual (TAU)
- description
- control group, no intervention administered
Primary outcomes (1)
- measure
- Universal Welch Emotional Connection Screen (uWECS)
- timeFrame
- From enrollment to the end of intervention and follow-up at 4 months
- description
- Emotional connection evaluated with the uWECS
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
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
References
Publications (0)
Data not yet available