NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

Not Yet RecruitingNA

Sponsor: Pamukkale University

Conditions: Overweight and/or Obesity

Interventions: Body-Based Regulation Program, Mind-Based Regulation Program

Countries: Turkey (Türkiye)

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 overview

Sex: FEMALE

Age: 18 Years to 60 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (1)

Denizli, Turkey (Türkiye)