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Life sciences · Interventional Study
ClinicalTrials.gov · October 7, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT07211217). This is a study registration, not published results. Lead sponsor: Massachusetts General Hospital. Recruitment status: RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 40 participants (ESTIMATED). Conditions: Bipolar Disorder (BD), Bipolar Disorder Depression, Overweight (BMI > 30). Interventions: OTHER: Time Restricted Eating. Primary outcome measures: Weight Loss , Week 0, Week 8, Week 20. Brief summary: This is a randomized controlled trial investigating the effects of an 8-TRE intervention compared to a wait list (control) on metabolic health and body composition in people diagnosed with BD and who are currently obese and at least mildly depressed. Following a 1-week baseline assessment, participants will be randomized to either a TRE or the wait list (1-to-1 ratio) for 8 weeks. At baseline, Week 8 (post treatment), and Week 20 (follow-up), investigators will assess daily eating patterns for one week, followed by collection of fasting lipids, body weight and vital signs. At Week 4 (i.e., mid-treatment), the investigators will assess self-reported outcomes only. Participants assigned to the wait list condition will have the option of receiving the TRE intervention after 20 weeks.