NCT07738263Not yet recruiting
Body-Based and Mind-Based Regulation in Overweight and Obese Women
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
Source: ClinicalTrials.gov · Last updated 31 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 6 Jul 2026
- Start date
- 1 Sept 2026
- Primary completion date
- 31 May 2027
- Lead sponsor
- Pamukkale University
- Diseases
- Obesity
- NCT number
- NCT07738263
What you commit to
- Study type: Interventional
- Planned participants: 30
- From 1 Sept 2026 to the primary completion date, 31 May 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Initiation of weight-loss medication or GLP-1 receptor agonist therapy within the previous 6 months.
- Regular tobacco or nicotine product use within the previous 3 months.
Other illness
- 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.
- History of bariatric surgery.
- 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.
- Musculoskeletal conditions preventing participation in the intervention.
Other
- BMI ≥40 kg/m².
- Pregnancy or breastfeeding.
- Cardiopulmonary or orthopedic limitations that make exercise unsafe.
Who the study is looking for
- 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.
Age in the registry: 18 years to 60 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Pamukkale University, Faculty of Physiotherapy and Rehabilitation, Exercise and Obesity Unit Coordinator of this site? Confirm its status | Denizli | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.