Time Restricted Eating (TRE) in Bipolar Disorder

Обзор

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.

Подробное описание

The overall goal of this study is to examine the effects of TRE on weight loss and secondary health outcomes in individuals with BD,. A secondary goal is to determine whether these effects are mediated by improvements in circadian rhythms.

Using an 8-week trial of 8-hour TRE compared to a wait list control group, the study will test the following specific aims:

* Examine the effect TRE on weight loss * if compared to wait list control, individuals assigned to TRE will have greater improvement in waist circumference, depression, anxiety, cognition, sleep and daily functioning. * if a change in circadian timing will significantly mediate the degree of improvement in body weight with TRE.

Our sample will be representative of the target population, or adults with bipolar disorder who are currently obese and depressed. The study interventions will be offered via telehealth to reduce barriers to access (e.g., childcare, time, parking/transportation costs, less time out of work).

Participants will have a study visit at the start (week 0), midway through (week 4), at the end of the 8-week intervention (week 8), and at a 3-month follow-up (week 20). Study visits will occur after 7 days of monitoring their food intake on Meallogger. To accommodate for scheduling conflicts that may arise, these visits can occur within +3 days of their scheduled dates, if necessary. Study procedures conducted during and surrounding these visits are the same for Weeks 0, 8 and 20.

To recognize participants for the time and effort involved in completing all study procedures.

Вмешательства

• Другое Time Restricted Eating
  See arms description

Первичные конечные точки

• Weight Loss [Срок оценки: Week 0, Week 8, Week 20]

Вторичные конечные точки (8)

• Patient Health Questionnaire-9 (PHQ-9) [Срок оценки: Week 0, Week 4, Week 8, Week 20]
• Generalized Anxiety Disorder scale (GAD-7) [Срок оценки: Week 0, Week 4, Week 8 and Week 20]
• Pittsburgh Sleep Quality Index (PSQI) [Срок оценки: Week 0, Week 4, Week 8, Week 20]
• Cognitive complaints in bipolar disorder rating assessment (COBRA) [Срок оценки: Week 0, Week 4, Week 8, Week 20]
• Patient-reported Outcome Measurement Information System (PROMIS) Cognitive Function Short Form 8a [Срок оценки: Week 0, Week 4, Week 8, Week 20]
• World Health Organization Disability Assessment Scale (WHODAS 2.0) [Срок оценки: Week 0, Week 4, Week 8, Week 20]
• The Altman Self-Rating Mania Scale (ASRM) [Срок оценки: Week 0, Week 4, Week 8, Week 20]
• Changes in waist size [Срок оценки: Week 0, 8, and 20]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Massachusetts General Hospital — Boston

Идентификаторы

NCT: NCT07211217 · 2025P002114

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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