Overweight and/or ObesityNCT07738263
Body-Based and Mind-Based Regulation in Overweight and Obese Women
A study testing Body-Based Regulation Program and Mind-Based Regulation Program in people with Overweight and/or Obesity, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Overweight and/or Obesity
- What is being tested?
- Body-Based Regulation Program and Mind-Based Regulation Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Sep 2026to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Pamukkale University, Faculty of Physiotherapy and Rehabilitation, Exercise and Obesity Unit
Denizli
Raziye Şavkın, Assoc. Prof., +902582964253, rkirkoluk@pau.edu.tr
Duygu Mert, PT
About this study
Official title: 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
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.
Read the detailed description
Overweight and obesity are associated not only with metabolic and physical health problems but also with changes in autonomic nervous system regulation, emotional eating, and psychological well-being. Reduced heart rate variability may reflect impaired cardiac vagal regulation and may be related to stress-related and emotion-related eating behaviors. Regulation-based approaches that target either body-to-mind or mind-to-body pathways may provide supportive strategies for improving autonomic and emotional regulation in women with overweight or obesity.
This study is designed as a two-arm, parallel-group, evaluator-blinded randomized trial. The study population will consist of women aged 18 to 60 years with overweight or obesity who apply to the Exercise and Obesity Unit of the Faculty of Physiotherapy and Rehabilitation, Pamukkale University. Participants will be randomized in a 1:1 ratio using BMI-category-stratified block randomization based on a computer-generated allocation sequence prepared by a researcher who is not involved in outcome assessment or intervention delivery. Allocation will be concealed until the baseline assessment is completed. The evaluator who performs baseline and post-intervention assessments will remain blinded to group allocation.
The Body-Based Regulation Group will receive an 8-week structured program delivered face-to-face by a physiotherapist. The program will include breathing awareness, body-awareness-based yoga practices, non-invasive manual auricular stimulation, and restorative relaxation. Sessions will be conducted twice weekly for 8 weeks, with each session lasting approximately 60 minutes. This intervention is intended to support autonomic and cardiac vagal regulation through body-based mechanisms.
The Mind-Based Regulation Group will receive an 8-week structured psychoeducation and cognitive-emotional awareness program. The program will focus on recognizing the relationships among stress, emotional states, automatic thoughts, and eating behavior; identifying triggers for emotional eating; developing more balanced cognitive responses; and creating alternative behavioral strategies for eating urges. Face-to-face structured sessions will be conducted in weeks 1, 4, and 8. In the remaining weeks, participants will receive standardized digital content and study forms and will attend short online meetings. The weekly module duration will be approximately 30 to 45 minutes. This intervention will not include yoga, breathing exercises, relaxation exercises, or other body-based practices.
Assessments will be conducted at baseline and after the 8-week intervention. Heart rate variability will be the primary physiological outcome. RR interval data will be recorded using a Polar H10 chest strap after a 10-minute quiet adaptation period, followed by a 5-minute resting recording. RMSSD will be the primary HRV parameter. If required according to distributional characteristics, RMSSD values will be analyzed after natural logarithmic transformation as lnRMSSD. Secondary HRV parameters will include HF, LF/HF, SDNN, and mean heart rate.
Patient-reported outcomes will include emotional eating, eating behavior, self-compassion, and mindfulness. Anthropometric measurements and body composition will be recorded as exploratory and descriptive outcomes. Adherence to the intervention, completion of home/module-related activities, and possible adverse events will also be monitored throughout the study.
The primary analysis will compare post-intervention RMSSD or lnRMSSD values between groups using an analysis of covariance model adjusted for baseline values. Secondary outcomes will be analyzed using similar baseline-adjusted models where appropriate. The study is planned to include 30 participants in total, with 15 participants in each group.
- Conditions
- Overweight and/or Obesity
- Being tested
- Body-Based Regulation Program, Mind-Based Regulation Program
- Keywords
- obesity, overweight, Heart Rate Variability, Emotional Eating, Body-Based Regulation, Mind-Based Regulation, Autonomic Nervous System, Psychological Well-Being, women, Randomized Controlled Trial
- Medical subject headings
- Obesity, Overweight, Emotional Eating, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Body-Based Regulation ProgramBehavioural
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.
Mind-Based Regulation ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Body-Based Regulation Group | Experimental | Participants 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. Receives: Behavioral: Body-Based Regulation Program |
| Mind-Based Regulation Group | Experimental | Participants 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. Receives: Behavioral: Mind-Based Regulation Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and Week 8
Secondary outcomes (10)
High-Frequency Power (HF)
Change in high-frequency (HF) power (ms²), an index of parasympathetic cardiac autonomic activity derived from heart rate variability recordings.
Measured: Baseline and Week 8
Low Frequency/High Frequency Ratio (LF/HF Ratio)
Change in the low frequency/high frequency (LF/HF) ratio derived from heart rate variability recordings.
Measured: Baseline and Week 8
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.
Measured: Baseline and Week 8
Mean Heart Rate
Change in resting mean heart rate (beats per minute [bpm]) measured during the heart rate variability assessment.
Measured: Baseline and Week 8
Eating Behavior (Dutch Eating Behavior Questionnaire, DEBQ)
Eating behavior will be assessed using the validated Turkish version of the 33-item Dutch Eating Behavior Questionnaire (DEBQ). The questionnaire comprises three subscales assessing emotional eating, external eating, and restrained eating. Items are rated on a 5-point Likert scale ranging from "never" to "very often," with an additional "not applicable" response option where appropriate. Scores for the emotional eating, external eating, and restrained eating subscales will be calculated and analyzed separately according to the validated scoring instructions. Higher scores on each subscale indicate a greater tendency toward the corresponding eating behavior.
Measured: Baseline and Week 8
Emotional Eating (Turkish Emotional Eating Scale)
Emotional eating will be assessed using the 30-item Turkish Emotional Eating Scale. Each item is rated on a 5-point Likert scale ranging from 1 ("never") to 5 ("almost always"). The scale evaluates the tendency to eat in response to emotional states and related difficulties in controlling eating behavior. A total score is calculated by summing the item scores, with possible scores ranging from 30 to 150. Higher scores indicate a greater tendency toward emotional eating.
Measured: Baseline and Week 8
Self-Compassion
Self-compassion will be assessed using the validated Turkish version of the 24-item Self-Compassion Scale. The scale evaluates how individuals respond to themselves during difficult or distressing experiences. Items are rated on a 5-point Likert scale ranging from "almost never" to "almost always." Negatively worded items will be reverse-scored according to the validated scoring instructions. A total score will be calculated, with higher scores indicating greater self-compassion.
Measured: Baseline and Week 8
Mindfulness
Mindfulness will be assessed using the validated Turkish version of the 15-item Mindful Attention Awareness Scale (MAAS). The scale evaluates an individual's general tendency to attend to and remain aware of present-moment experiences in daily life. Items are rated on a 6-point Likert scale ranging from "almost always" to "almost never." A single overall score will be calculated according to the validated scoring instructions. Higher scores indicate greater mindful awareness.
Measured: Baseline and Week 8
Protocol Adherence
The percentage of prescribed intervention components completed will be recorded. In the Body-Based Regulation Group, adherence will be calculated based on attendance at the 16 supervised face-to-face sessions. In the Mind-Based Regulation Group, adherence will be calculated based on completion of weekly modules, digital content, brief online meetings, and study forms. Participants completing at least 80% of the prescribed intervention components will be classified as protocol completers.
Measured: Through Week 8
Participants With Intervention-Related Adverse Events
The number and type of symptoms, unexpected health problems, and adverse events occurring during or after the interventions and considered possibly related to the intervention will be recorded.
Measured: Through Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2026
- Study startSep 2026 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and/or ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to one of two parallel intervention groups: a body-based regulation group or a mind-based regulation group. Outcome assessments will be performed at baseline and after completion of the intervention.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raziye Şavkın, Pamukkale University
- Investigators
- Raziye ŞAVKIN, PhD, Study chair, Pamukkale University, Faculty of Physiotherapy and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07738263
- Sponsor's protocol ID
- E-60116787-020-895690
- Status last verified
- Jul 2026
- First submitted
- 6 Jul 2026
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07738263
- Acronym / sponsor ID
- E-60116787-020-895690
- Conditions
- Overweight and/or Obesity
- Keywords
- obesity, overweight, Heart Rate Variability, Emotional Eating, Body-Based Regulation, Mind-Based Regulation, Autonomic Nervous System, Psychological Well-Being
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 31 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Overweight and obesity are associated not only with metabolic and physical health problems but also with changes in autonomic nervous system regulation, emotional eating, and psychological well-being. Reduced heart rate variability may reflect impaired cardiac vagal regulation and may be related to stress-related and emotion-related eating behaviors. Regulation-based approaches that target either body-to-mind or mind-to-body pathways may provide supportive strategies for improving autonomic and emotional regulation in women with overweight or obesity.
This study is designed as a two-arm, parallel-group, evaluator-blinded randomized trial. The study population will consist of women aged 18 to 60 years with overweight or obesity who apply to the Exercise and Obesity Unit of the Faculty of Physiotherapy and Rehabilitation, Pamukkale University. Participants will be randomized in a 1:1 ratio using BMI-category-stratified block randomization based on a computer-generated allocation sequence prepared by a researcher who is not involved in outcome assessment or intervention delivery. Allocation will be concealed until the baseline assessment is completed. The evaluator who performs baseline and post-intervention assessments will remain blinded to group allocation.
The Body-Based Regulation Group will receive an 8-week structured program delivered face-to-face by a physiotherapist. The program will include breathing awareness, body-awareness-based yoga practices, non-invasive manual auricular stimulation, and restorative relaxation. Sessions will be conducted twice weekly for 8 weeks, with each session lasting approximately 60 minutes. This intervention is intended to support autonomic and cardiac vagal regulation through body-based mechanisms.
The Mind-Based Regulation Group will receive an 8-week structured psychoeducation and cognitive-emotional awareness program. The program will focus on recognizing the relationships among stress, emotional states, automatic thoughts, and eating behavior; identifying triggers for emotional eating; developing more balanced cognitive responses; and creating alternative behavioral strategies for eating urges. Face-to-face structured sessions will be conducted in weeks 1, 4, and 8. In the remaining weeks, participants will receive standardized digital content and study forms and will attend short online meetings. The weekly module duration will be approximately 30 to 45 minutes. This intervention will not include yoga, breathing exercises, relaxation exercises, or other body-based practices.
Assessments will be conducted at baseline and after the 8-week intervention. Heart rate variability will be the primary physiological outcome. RR interval data will be recorded using a Polar H10 chest strap after a 10-minute quiet adaptation period, followed by a 5-minute resting recording. RMSSD will be the primary HRV parameter. If required according to distributional characteristics, RMSSD values will be analyzed after natural logarithmic transformation as lnRMSSD. Secondary HRV parameters will include HF, LF/HF, SDNN, and mean heart rate.
Patient-reported outcomes will include emotional eating, eating behavior, self-compassion, and mindfulness. Anthropometric measurements and body composition will be recorded as exploratory and descriptive outcomes. Adherence to the intervention, completion of home/module-related activities, and possible adverse events will also be monitored throughout the study.
The primary analysis will compare post-intervention RMSSD or lnRMSSD values between groups using an analysis of covariance model adjusted for baseline values. Secondary outcomes will be analyzed using similar baseline-adjusted models where appropriate. The study is planned to include 30 participants in total, with 15 participants in each group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to one of two parallel intervention groups: a body-based regulation group or a mind-based regulation group. Outcome assessments will be performed at baseline and after completion of the intervention.
| Arm | Type | Receives |
|---|---|---|
| Body-Based Regulation Group | Experimental | Behavioral: Body-Based Regulation ProgramParticipants 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 | Experimental | Behavioral: Mind-Based Regulation ProgramParticipants 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Body-Based Regulation ProgramParticipants 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. | Behavioural | Body-Based Regulation Group |
| Mind-Based Regulation ProgramParticipants 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. | Behavioural | Mind-Based Regulation Group |
Primary outcome
Heart Rate Variability (RMSSD)
Time frame: Baseline and Week 8
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.
10 secondary outcomes
High-Frequency Power (HF)
Time frame: Baseline and Week 8
Low Frequency/High Frequency Ratio (LF/HF Ratio)
Time frame: Baseline and Week 8
Standard Deviation of NN Intervals (SDNN)
Time frame: Baseline and Week 8
Mean Heart Rate
Time frame: Baseline and Week 8
Eating Behavior (Dutch Eating Behavior Questionnaire, DEBQ)
Time frame: Baseline and Week 8
Emotional Eating (Turkish Emotional Eating Scale)
Time frame: Baseline and Week 8
Self-Compassion
Time frame: Baseline and Week 8
Mindfulness
Time frame: Baseline and Week 8
Protocol Adherence
Time frame: Through Week 8
Participants With Intervention-Related Adverse Events
Time frame: Through Week 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Raziye ŞAVKIN, PhD study chair
Pamukkale University, Faculty of Physiotherapy and Rehabilitation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Body-Based Regulation Program and Mind-Based Regulation Program in people with Overweight and/or Obesity, run by Pamukkale University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Raziye ŞAVKIN, Assoc. Prof. (+902582964253, rkirkoluk@pau.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart Rate Variability (RMSSD) (time frame: Baseline and Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.