Time Restricted Eating (TRE) in Bipolar Disorder (NCT07211217)
๐ฉบ Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Massachusetts General Hospital โ Boston, Massachusetts
Age range: 18 Years to 65 Years
๐งช Interventions in This Study
- Time Restricted Eating (OTHER)
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (1 Sites)
- Massachusetts General Hospital โ Boston, Massachusetts
๐ Contact the Study Coordinator
Phone: (617) 643-9923
Email: gchau1@mgh.harvard.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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- Child Bipolar Network Ketogenic Diet Approach to Bipolar Disorder in Adolescents โ Los Angeles, California
- FOCUS Bipolar: Families Opening Conversations for Understanding Signs โ Dallas, Texas
- Multimodal Intervention to Support Hospital-to-Community Transition in Bipolar Disorder โ Hamilton, Ontario
Explore by condition: All Bipolar Disorder (BD) clinical trials
๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.