Time Restricted Eating Tested in Adults With Bipolar Disorder and Obesity
Tests a daily eating window plan in adults with bipolar disorder who have obesity.
Plain-language title generated from the registry record
Registry title: Time Restricted Eating (TRE) in Bipolar Disorder
Key facts
- Where
- Boston, United StatesSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT07211217, who can take part
Where in United States
- Massachusetts General HospitalBoston, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Massachusetts General Hospital
- Trial code
- NCT07211217
- Record updated
- 10 November 2026
- Original description
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.Read full original descriptionShow less
Time Restricted Eating (TRE) in Bipolar Disorder
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.
Inclusion: Adults (aged 18-65 years); Diagnosed with bipolar disorder (i.e., subtype Bipolar I or II as assessed with the Quick SCID)21; Currently experiencing depression (i.e., PHQ-9 ≥ 10)22; Currently overweight (i.e., Body mass index (BMI) > 30 kg/m2); Provides Informed Consent.
Exclusion: Dietary factors:; Diagnosis, or strong clinical suspicion, of eating disorders, including but not limited to, anorexia nervosa, bulimia nervosa, binge eating disorder (as assessed with the Quick SCID); Concurrent dietary intervention or modification unrelated to study procedures; Medical factors:; Use of weight loss medications or supplements; Use of medications that may cause weight loss or gain, unless body weight and medication usage remained stable for at least 6 months; Previous weight loss surgery; Malignancy within past 2 years; Major surgery within past 3 months; Medical instability considered to interfere with study procedures; Use of medications that have the potential to cause hypoglycemia (e.g., insulin, sulfonylureas); Undergoing treatment for cancer; Use of medications for which time restricted eating would interfere with recommended timing of medication ingestion with food intake; Psychiatric factors:; Severe depression (i.e., PHQ-9>20); Experiencing manic symptoms (i.e., ASRM < 6)23; Active suicidal ideation (i.e., PHQ-9, item 9 >2); Current alcohol/substance use disorder (as assessed with the Quick SCID); Lifestyle and other factors:; Work or social schedules that would impede ability to adhere to study protocol; Adherence factors:; Ability to adhere to study procedures.