Body-Based and Mind-Based Regulation in Overweight and Obese Women
ConditionOverweight and/or Obesity
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-60
SponsorPamukkale University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
Body-Based Regulation Program
BehavioralParticipants 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
BehavioralParticipants 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.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Body-Based Regulation GroupExperimental treatment 1 intervention
Group B: Mind-Based Regulation GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Heart Rate Variability (RMSSD)
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.
Time frame
Baseline and Week 8Secondary outcomes
1
High-Frequency Power (HF)
Change in high-frequency (HF) power (ms²), an index of parasympathetic cardiac autonomic activity derived from heart rate variability recordings.
Time frame
Baseline and Week 82
Low Frequency/High Frequency Ratio (LF/HF Ratio)
Change in the low frequency/high frequency (LF/HF) ratio derived from heart rate variability recordings.
Time frame
Baseline and Week 83
Standard Deviation of NN Intervals (SDNN)
Change in the standard deviation of normal-to-normal intervals (SDNN, ms), a time-domain heart rate variability parameter reflecting overall autonomic variability.
Time frame
Baseline and Week 84
Mean Heart Rate
Change in resting mean heart rate (beats per minute \[bpm\]) measured during the heart rate variability assessment.
Time frame
Baseline and Week 8Other outcomes
1
Body Weight
Change in body weight measured in kilograms using a calibrated digital scale
Time frame
Baseline and Week 82
Body Mass Index (BMI)
Change in body mass index (kg/m²) calculated as weight in kilograms divided by height in meters squared.
Time frame
Baseline and Week 83
Waist Circumference
Change in waist circumference (cm) measured using a non-stretch measuring tape.
Time frame
Baseline and Week 84
Hip Circumference
Change in hip circumference (cm) measured using a non-stretch measuring tape.
Time frame
Baseline and Week 8Sponsors and contacts
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Source ClinicalTrials.gov
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