Body- or Mind-based regulation in women with overweight or obesity

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a two-arm, evaluator-blinded randomized trial comparing an 8-week body-based regulation program (breathing awareness, body-focused yoga, non-invasive auricular stimulation, and relaxation) with a mind-based regulation program (psychoeducation and cognitive-emotional awareness for stress, emotions, and emotional eating) in women aged 18-60 with BMI 27.0–39.9. Participants are assigned 1:1 and assessments are conducted by blinded evaluators at baseline and after the intervention. The primary outcome is changes in heart rate variability (RMSSD) as a marker of cardiac vagal regulation; secondary outcomes include emotional eating, self-compassion, and mindfulness. The study is conducted at Pamukkale University in Denizli, Turkey, with randomization stratified by BMI category and allocation concealed until baseline assessments are complete.

Why it matters

Who can join: the full rules

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.

Where it's running

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

Study contacts

• Study coordinator: Raziye ŞAVKIN, Assoc. Prof.
• Email: rkirkoluk@pau.edu.tr
• Phone: +902582964253

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Weekly berobenatide for knee osteoarthritis in adults who are overweight or obese

  This study tests whether weekly berobenatide helps reduce knee pain and improve function, while also affecting body weight, in adults with knee osteoarthritis who are overweight or obese (with or without type 2 diabetes).

  Recruiting Phase 3 Pfizer · Birmingham, Alabama and 3 other locations · NCT07915609

• Berobenatide in adults with sleep apnea and obesity who don’t use a PAP machine

  This study tests berobenatide versus placebo in adults with moderate-to-severe obstructive sleep apnea and overweight or obesity who are not using PAP therapy.

  Recruiting at 3 sites Phase 3 Pfizer · Cullman, Alabama and 3 other locations · NCT07881757

• Berobenatide: how it enters the blood after different delivery methods in adults with overweight or obesity

  This study tests a single dose of Berobenatide to see how it behaves in the body when given in different delivery forms to adults with overweight or obesity.

  Recruiting Phase 1 Pfizer · Anaheim, California · NCT07876531

• Switching to a monthly dose of Berobenatide to help keep weight off after weight loss with semaglutide or tirzepatide

  This study tests whether switching to a monthly berobenatide shot can help adults who have overweight or obesity and have already lost weight using semaglutide or tirzepatide to keep the weight off.

  Recruiting at 18 sites Phase 3 Pfizer · Birmingham, Alabama and 25 other locations · NCT07845500

• Berobenatide in adults with sleep apnea and obesity using a PAP machine

  This study tests berobenatide vs. placebo in adults with moderate to severe obstructive sleep apnea and overweight/obesity who use a PAP device.

  Recruiting at 6 sites Phase 3 Pfizer · Cullman, Alabama and 7 other locations · NCT07823608

• Semaglutide delivered by a needle-free skin patch versus injections in adults with overweight or obesity

  This early study tests a needle-free skin patch delivering semaglutide against standard injections in adults who are overweight or obese to see if the patch works safely and as well as injections.

  Recruiting Phase 1 Terrestrial Bio, Inc. · Tempe, Arizona · NCT07673900

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.