Time Restricted Eating in Bipolar Disorder and Obesity

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, controlled study compares an 8-week time-restricted eating (TRE) plan to a wait-list control in adults with bipolar disorder who are overweight and depressed. After a 1-week baseline, participants are assigned 1:1 to TRE or wait-list, with assessments at weeks 0, 4, 8, and 20, including metabolic measures, body weight, and daily eating patterns. The TRE group will follow an 8-hour eating window, with telehealth delivery to improve access, and outcomes include weight loss, waist circumference, mood, cognition, sleep, and daily functioning. The study also explores whether changes in circadian timing mediate weight changes. Follow-up care offers TRE to wait-list participants after 20 weeks.

Why it matters

Who can join: the full rules

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:

1. Dietary factors:

   1. 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)
   2. Concurrent dietary intervention or modification unrelated to study procedures
2. Psychiatric factors:

   1. Severe depression (i.e., PHQ-9\>20)
   2. Experiencing manic symptoms (i.e., ASRM \< 6)23
   3. Active suicidal ideation (i.e., PHQ-9, item 9 \>2)
   4. Current alcohol/substance use disorder (as assessed with the Quick SCID)
3. Medical factors:

   1. Use of weight loss medications or supplements
   2. Use of medications that may cause weight loss or gain, unless body weight and medication usage remained stable for at least 6 months
   3. Previous weight loss surgery
   4. Malignancy within past 2 years
   5. Major surgery within past 3 months
   6. Medical instability considered to interfere with study procedures
   7. Use of medications that have the potential to cause hypoglycemia (e.g., insulin, sulfonylureas)
   8. Undergoing treatment for cancer
   9. Use of medications for which time restricted eating would interfere with recommended timing of medication ingestion with food intake.
4. Lifestyle and other factors:

   a. Work or social schedules that would impede ability to adhere to study protocol
5. Adherence factors:

   1. Ability to adhere to study procedures

Where it's running

• Massachusetts General Hospital
  Boston, Massachusetts, United States Recruiting

Study contacts

• Principal investigator: Louisa G. Sylvia, PhD — Massachusetts General Hospital
• Study coordinator: Giuliana M Chau
• Email: gchau1@mgh.harvard.edu
• Phone: 16176439923

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.