Time Restricted Eating (TRE) in Bipolar Disorder
Recruiting · NCT07211217 · Interventional (participants receive a specific treatment) · Lead sponsor: Massachusetts General Hospital
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 take part
Inclusion criteria
- 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 criteria
- 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
- 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)
- 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.
- Lifestyle and other factors:
- a. Work or social schedules that would impede ability to adhere to study protocol
- Adherence factors:
- Ability to adhere to study procedures
Where it is running
1 location listed across 1 US state.
- Massachusetts General Hospital - Boston, Massachusetts, United States