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Clinical Trials in Turkey / NCT07738263
Starting soon Not applicable

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

NCT07738263 · tracked via the Priya Life Science Turkey tracker
Sponsor
Pamukkale University
Phase
Not applicable
Started
2026-09
Last updated
2026-07-31

Condition(s) studied

Overweight and/or Obesity

Investigational drug(s) / intervention(s)

Body-Based Regulation ProgramMind-Based Regulation Program

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.

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.

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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
60 Years
Healthy volunteers
No
Inclusion Criteria: * Female participants. * Age between 18 and 60 years. * Body mass index (BMI) between 27.0 and 39.9 kg/m². * No regular participation in yoga, meditation, breathing exercises, structured relaxation programs, or similar mind-body practices within the previous 3 months. * No initiation of a structured weight-loss program within the previous 3 months. * Able to attend weekly intervention sessions, modules, and study assessments. * Willing to refrain from starting any new exercise, yoga, meditation, diet, or weight-loss program during the study. * Able and willing to provide written informed consent. Exclusion Criteria: * BMI ≥40 kg/m². * Uncontrolled hypertension or severe cardiovascular disease. * Cardiac arrhythmia, pacemaker, or other cardiac conditions that may affect heart rate variability (HRV). * Regular use of beta-blockers, antiarrhythmic agents, or other medications that substantially affect HRV (including medications affecting heart rate/rhythm, anticholinergic drugs, tricyclic antidepressants, and stimulant/sympathomimetic medications). * Neurological disease. * Uncontrolled thyroid disease or uncontrolled metabolic/endocrine disorders. * Pregnancy or breastfeeding. * History of bariatric surgery. * Initiation of weight-loss medication or GLP-1 receptor agonist therapy within the previous 6 months. * Current or clinically diagnosed anorexia nervosa, bulimia nervosa, binge eating disorder, or other eating disorders requiring active treatment (emotional eating alone is not an exclusion criterion). * Psychological or psychiatric conditions that would interfere with safe participation. * Diagnosed obstructive sleep apnea or untreated severe sleep disorders. * Regular tobacco or nicotine product use within the previous 3 months. * Musculoskeletal conditions preventing participation in the intervention. * Cardiopulmonary or orthopedic limitations that make exercise unsafe.

Primary outcome measure(s)

  • Heart Rate Variability (RMSSD) — Baseline and Week 8
    RMSSD (ms) will be derived from a 5-minute resting RR-interval recording obtained using a Polar H10 chest strap and analyzed using Kubios HRV software. If required based on distributional characteristics, RMSSD values will be natural-log transformed and analyzed as lnRMSSD.

Trial sites (1)

FacilityCityRegionStatus
Pamukkale University, Faculty of Physiotherapy and Rehabilitation, Exercise and Obesity Unit Denizli Turkey (Türkiye)

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07738263 on ClinicalTrials.gov ↗ ← All trials in Turkey