Time Restricted Eating (TRE) in Bipolar Disorder
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 主要终点
- Weight Loss
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Waitlist Condition
Participants assigned to the wait list condition will have the option of receiving the TRE intervention after 20 weeks.
Time Restrictive Eating Condition
TRE is a dietary intervention where participants eat all of their food within a specific 8-hour eating window, for example eating only between 10am and 6pm. Participants will not be asked to change what they eat, only when to eat. Participants will keep a daily Food Timing Log to record the time of the first and last food and drink that they consume each day. The study will ask participants to continue to do this daily throughout the study (~8 weeks).
干预措施: Time Restricted Eating (Other)
结局指标
主要结局
Weight Loss
时间窗: Week 0, Week 8, Week 20
Body weight will be collected in the fasted state using a digital scale (lbs)
次要结局
- Patient Health Questionnaire-9 (PHQ-9)(Week 0, Week 4, Week 8, Week 20)
- Generalized Anxiety Disorder scale (GAD-7)(Week 0, Week 4, Week 8 and Week 20)
- Pittsburgh Sleep Quality Index (PSQI)(Week 0, Week 4, Week 8, Week 20)
- Patient-reported Outcome Measurement Information System (PROMIS) Cognitive Function Short Form 8a(Week 0, Week 4, Week 8, Week 20)
- World Health Organization Disability Assessment Scale (WHODAS 2.0)(Week 0, Week 4, Week 8, Week 20)
- The Altman Self-Rating Mania Scale (ASRM)(Week 0, Week 4, Week 8, Week 20)
- Cognitive complaints in bipolar disorder rating assessment (COBRA)(Week 0, Week 4, Week 8, Week 20)
- Changes in waist size(Week 0, 8, and 20)
研究者
Louisa Grandin Sylvia
Associate Director
Massachusetts General Hospital