Not Yet RecruitingNot Applicable

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

Turkey (Türkiye)30 participantsStarted 2026-09

Plain-language 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.

Who can participate

Age range

18 Years – 60 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 (em…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Heart Rate Variability (RMSSD)

Timeframe: Baseline and Week 8

Trial details

NCT IDNCT07738263

SponsorPamukkale University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-05

Contact for this trial

Raziye ŞAVKIN, Assoc. Prof.

+902582964253 rkirkoluk@pau.edu.tr

View on ClinicalTrials.gov More Overweight and/or Obesity trials