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

Authors
Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2026
Overweight and obesity are associated not only with metabolic and physical healthproblems but also with changes in autonomic nervous system regulation, emotional eating,and psychological well‐being. Reduced heart rate variability may reflect impaired cardiacvagal regulation and may be related to stress‐related and emotion‐related eatingbehaviors. Regulation‐based approaches that target either body‐to‐mind or mind‐to‐bodypathways may provide supportive strategies for improving autonomic and emotionalregulation 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 obesitywho apply to the Exercise and Obesity Unit of the Faculty of Physiotherapy andRehabilitation, Pamukkale University. Participants will be randomized in a 1:1 ratiousing BMI‐category‐stratified block randomization based on a computer‐generatedallocation sequence prepared by a researcher who is not involved in outcome assessment orintervention delivery. Allocation will be concealed until the baseline assessment iscompleted. The evaluator who performs baseline and post‐intervention assessments willremain blinded to group allocation.The Body‐Based Regulation Group will receive an 8‐week structured program deliveredface‐to‐face by a physiotherapist. The program will include breathing awareness,body‐awareness‐based yoga practices, non‐invasive manual auricular stimulation, andrestorative relaxation. Sessions will be conducted twice weekly for 8 weeks, with eachsession lasting approximately 60 minutes. This intervention is intended to supportautonomic and cardiac vagal regulation through body‐based mechanisms.The Mind‐Based Regulation Group will receive an 8‐week structured psychoeducation andcognitive‐emotional awareness program. The program will focus on recognizing therelationships 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 structuredsessions will be conducted in weeks 1, 4, and 8. In the remaining weeks, participantswill receive standardized digital content and study forms and will attend short onlinemeetings. The weekly module duration will be approximately 30 to 45 minutes. Thisintervention will not include yoga, breathing exercises, relaxation exercises, or otherbody‐based practices.Assessments will be conducted at baseline and after the 8‐week intervention. Heart ratevariability will be the primary physiological outcome. RR interval data will be recordedusing a Polar H10 chest strap after a 10‐minute quiet adaptation period, followed by a5‐minute resting recording. RMSSD will be the primary HRV parameter. If requiredaccording to distributional characteristics, RMSSD values will be analyzed after naturallogarithmic 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 willbe recorded as exploratory and descriptive outcomes. Adherence to the intervention,completion of home/module‐related activities, and possible adverse events will also bemonitored throughout the study.The primary analysis will compare post‐intervention RMSSD or lnRMSSD values betweengroups using an analysis of covariance model adjusted for baseline values. Secondaryoutcomes will be analyzed using similar baseline‐adjusted models where appropriate. Thestudy is planned to include 30 participants in total, with 15 participants in each group.
Epistemonikos ID: 10de66f076c4711fa96736d7c01deb765998db99
First added on: Aug 01, 2026