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NOT YET RECRUITING
NCT07738263
NA

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

Sponsor: Pamukkale University

View on ClinicalTrials.gov

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.

Official title: Effects of Body-Based and Mind-Based Regulation Approaches on Heart Rate Variability, Emotional Eating, and Psychological Indicators in Overweight and Obese Women: An Evaluator-Blinded Randomized Trial

Key Details

Gender

FEMALE

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2026-09

Completion Date

2027-05

Last Updated

2026-07-31

Healthy Volunteers

No

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.

Locations (1)

Pamukkale University, Faculty of Physiotherapy and Rehabilitation, Exercise and Obesity Unit

Denizli, Turkey (Türkiye)