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

NCT07129434 | Recruiting

• 1 other identifier: ECoFam PEPPI Pilot RCT
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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. 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. 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

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

Outcome Measures

Primary Outcomes (1)

• Universal Welch Emotional Connection Screen (uWECS)

  Emotional connection evaluated with the uWECS

  From enrollment to the end of intervention and follow-up at 4 months

Secondary Outcomes (1)

• Mothers' mental health problems

  From enrollment to end of intervention and follow-up 4 months

Study Arms (2)

ECoFam intervention

EXPERIMENTAL

personalized coaching sessions

Behavioral: ECoFam

treatment-as-usual (TAU)

NO INTERVENTION

control group, no intervention administered

Interventions

ECoFam BEHAVIORAL

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.

ECoFam intervention

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- Infant death

Sponsors & Collaborators

• Oulu University Hospital: lead
• University of Oulu: collaborator

Study Sites (1)

Oulu University Hospital

Oulu, Finland

RECRUITING

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Obesity; Overweight

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Julia Jäkel, Dr. phil. habil.

  University of Oulu

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julia Jaekel, PhD

CONTACT

358458043150; apfelliebhaber@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: August 4, 2025
• First Posted: August 19, 2025
• Study Start: April 15, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)