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NCT Number: NCT07129434

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

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.

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Key information

Conditions

Polycystic Ovary Syndrome (PCOS) Adnexal Diseases Body Weight Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Neoplasms Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity &Amp;Amp; Overweight Ovarian Cysts Ovarian Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Polycystic Ovary Syndrome Signs and Symptoms Urogenital Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Oulu University Hospital

Oulu, Finland

Location status: Recruiting

Location contact

Jaana Nevalainen, MD PhD

CONTACT

[email protected]

358405801857

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Universal Welch Emotional Connection Screen (uWECS)

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

    Emotional connection evaluated with the uWECS

Secondary outcomes

  1. Mothers' mental health problems

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

    Mothers' mental health problems are assessed with a range of standardized questionnaires using RedCap; higher scores mean worse outcomes.

Study contacts

Contact information is provided by the study sponsor or research team.

Julia Jaekel, PhD

CONTACT

[email protected]

358458043150

Sponsors and collaborators

Lead sponsor

Oulu University Hospital

Other

Collaborators

  • University of Oulu

Registry information

Acronym: ECoFam

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 19, 2025
Registry last updated
Aug 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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