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
1 other identifier
interventional
30
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2026
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 6, 2026
CompletedFirst Posted
Study publicly available on registry
July 31, 2026
CompletedStudy Start
First participant enrolled
September 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2027
Study Completion
Last participant's last visit for all outcomes
May 1, 2027
July 31, 2026
July 1, 2026
8 months
July 6, 2026
July 30, 2026
Conditions
Keywords
Outcome Measures
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.
Baseline and Week 8
Secondary Outcomes (10)
High-Frequency Power (HF)
Baseline and Week 8
Low Frequency/High Frequency Ratio (LF/HF Ratio)
Baseline and Week 8
Standard Deviation of NN Intervals (SDNN)
Baseline and Week 8
Mean Heart Rate
Baseline and Week 8
Eating Behavior (Dutch Eating Behavior Questionnaire, DEBQ)
Baseline and Week 8
- +5 more secondary outcomes
Other Outcomes (8)
Body Weight
Baseline and Week 8
Body Mass Index (BMI)
Baseline and Week 8
Waist Circumference
Baseline and Week 8
- +5 more other outcomes
Study Arms (2)
Body-Based Regulation Group
EXPERIMENTALParticipants assigned to this arm will receive an 8-week body-based regulation program delivered by a physiotherapist. The intervention aims to improve body awareness, autonomic regulation, and emotional regulation. Outcome assessments will be conducted at baseline and at the end of the intervention.
Mind-Based Regulation Group
EXPERIMENTALParticipants assigned to this arm will receive an 8-week mind-based regulation program consisting of structured psychoeducation and cognitive-emotional awareness practices. Outcome assessments will be conducted at baseline and at the end of the intervention.
Interventions
Participants 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.
Participants 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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pamukkale University, Faculty of Physiotherapy and Rehabilitation, Exercise and Obesity Unit
Denizli, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Raziye ŞAVKIN, PhD
Pamukkale University, Faculty of Physiotherapy and Rehabilitation
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Outcome assessments will be performed by an evaluator who is blinded to the participants' group allocation. The evaluator will not be involved in the intervention or randomization procedures.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assoc. Prof.
Study Record Dates
First Submitted
July 6, 2026
First Posted
July 31, 2026
Study Start (Estimated)
September 1, 2026
Primary Completion (Estimated)
May 1, 2027
Study Completion (Estimated)
May 1, 2027
Last Updated
July 31, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will not share