Combined Yogic Practices and Ayurvedic Dinacharya in Adults With Perceived Stress Poor Sleep and Metabolic Risk Study Protocol for a Three Arm Randomized Controlled Trial
Abstract
Background: Perceived stress, poor sleep, physical inactivity and metabolic risk commonly occur together. Yoga may improve stress and sleep, while Ayurvedic Dinacharya provides a structured framework for waking, hygiene, physical activity, meal timing and sleep. Existing studies do not establish whether adding a standardized Dinacharya programme provides benefit beyond Yoga alone. Objective: To determine whether a 12-week programme of standardized Yoga plus Ayurvedic Dinacharya reduces perceived stress more than standard lifestyle advice and whether Dinacharya adds benefit beyond the same Yoga programme alone. Methods: This assessor-blinded, three-arm, parallel randomized controlled trial will enrol 228 adults aged 18 to 60 years with an operationally defined elevated Perceived Stress Scale score, poor sleep quality and at least one metabolic risk indicator. Participants will be allocated equally to standard lifestyle advice, standardized Yoga, or the same Yoga programme plus standardized Dinacharya. The intervention will last 12 weeks, with follow-up at week 24. The primary outcome is change in the 10-item Perceived Stress Scale score from baseline to week 12 for Yoga plus Dinacharya versus standard advice. Secondary outcomes include sleep quality, anthropometry, blood pressure, fasting glucose, lipid profile, adherence and adverse events. The primary analysis will follow the intention-to-treat principle. Ethics and registration: Institutional ethics approval and prospective Clinical Trials Registry India registration will be obtained before the first participant is enrolled. Written informed consent will be required. Trial findings will be reported regardless of direction or statistical significance. Trial status: Recruitment has not started. The planned recruitment period is 12 months after ethics approval and prospective registration.
