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Body-Based and Mind-Based Regulation in Overweight and Obese Women

NCT07738263 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-07-31

No results posted yet for this study

Summary

This study will compare two regulation-based approaches in women with overweight or obesity. The first approach is a body-based regulation program including breathing awareness, body-awareness-based yoga practices, non-invasive manual auricular stimulation, and restorative relaxation. The second approach is a mind-based regulation program including structured psychoeducation and cognitive-emotional awareness activities focused on stress, emotions, automatic thoughts, and emotional eating.

Participants will be women aged 18 to 60 years with a body mass index between 27.0 and 39.9 kg/m². Eligible participants will be randomly assigned to one of the two intervention groups. Both programs will last 8 weeks.

The main aim of the study is to examine and compare the preliminary effects of these two approaches on heart rate variability, especially RMSSD, which is an indicator of cardiac vagal regulation. The study will also assess emotional eating, self-compassion, mindfulness, body measurements, body composition, adherence to the program, and possible adverse events. Assessments will be performed at baseline and after the 8-week intervention by an evaluator who is blinded to group allocation.

Conditions

  • Overweight and/or Obesity

Interventions

BEHAVIORAL

Body-Based Regulation Program

Participants will receive an 8-week structured body-based regulation program administered by a physiotherapist. The program consists of 16 supervised face-to-face sessions (twice weekly, 60 minutes each) including breathing awareness exercises, body awareness-based yoga practices, non-invasive manual auricular stimulation, and restorative relaxation techniques. The intervention is designed to improve body awareness, autonomic nervous system regulation, and emotional regulation.

BEHAVIORAL

Mind-Based Regulation Program

Participants will receive an 8-week structured psychoeducation and cognitive-emotional awareness program developed by a clinical psychologist. The intervention aims to improve awareness of the relationships among stress, emotions, automatic thoughts, and eating behavior, recognize emotional eating triggers, develop balanced cognitive responses, and strengthen adaptive coping strategies. The program includes face-to-face sessions during weeks 1, 4, and 8, standardized digital educational materials, weekly online follow-up meetings, and self-monitoring exercises. No yoga, breathing exercises, relaxation exercises, or body-based practices are included.

Sponsors & Collaborators

  • Pamukkale University

    lead OTHER

Principal Investigators

  • Raziye ŞAVKIN, PhD · Pamukkale University, Faculty of Physiotherapy and Rehabilitation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2027-05-31
Completion
2027-05-31

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07738263 on ClinicalTrials.gov