Cognitive Behavioral Therapy for Insomnia as an Adjunct to Time-restricted Eating on Weight Loss in Adults With Overweight or Obesity and Chronic Insomnia

This study aims to investigate whether CBTI can enhance the effectiveness of TRE forweight control in adults with chronic insomnia and overweight or obesity. Thisassessor‐blinded, two‐arm, parallel‐group randomized controlled pilot trial plans torecruit 50 Chinese adults aged 18 years or older with chronic insomnia and overweight orobesity (BMI ≥23 kg/m²) in Hong Kong. Participants will be randomized (1:1) to a flexibletime‐restricted eating group (FTRE, n=25) or a flexible time‐restricted eating plus CBTIgroup (CBTI+FTRE, n=25). Both groups will follow a 16:8 time‐restricted eating schedulefor 12 weeks, while participants in the CBTI+FTRE group will additionally receive a12‐week group‐based CBTI program consisting of biweekly 90‐minute sessions. Assessmentswill be conducted at baseline, post‐intervention (week 12), and follow‐up (week 24). Theprimary outcome is body weight. Secondary outcomes include body mass index, waist andneck circumferences, body composition, insomnia severity, sleep quality, objective andsubjective sleep parameters, physical activity, blood pressure, appetite, food intake,eating window, and exercise habits. We hypothesize that the addition of CBTI to TRE willresult in greater weight loss and improved sleep outcomes compared with TRE alone