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| Name | Class |
|---|---|
| Brigham and Women's Hospital | OTHER |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Time Restrictive Eating Condition | Active Comparator | 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). |
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| Waitlist Condition | No Intervention | Participants assigned to the wait list condition will have the option of receiving the TRE intervention after 20 weeks. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Time Restricted Eating | Other | See arms description |
|
| Measure | Description | Time Frame |
|---|---|---|
| Weight Loss | Body weight will be collected in the fasted state using a digital scale (lbs) | Week 0, Week 8, Week 20 |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Health Questionnaire-9 (PHQ-9) | It is a 9-item self-report questionnaire that is widely used to assess depression symptom severity. A PHQ-9 score ≥10 has a sensitivity of 88% and a specificity of 88% for major depression. PHQ-9 scores of 5, 10, 15, and 20 represented mild, moderate, moderately severe, and severe depression, respectively. | Week 0, Week 4, Week 8, Week 20 |
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Inclusion Criteria:
Exclusion Criteria:
Dietary factors:
Psychiatric factors:
Medical factors:
Lifestyle and other factors:
a. Work or social schedules that would impede ability to adhere to study protocol
Adherence factors:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Giuliana M Chau | Contact | 16176439923 | gchau1@mgh.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Louisa G. Sylvia, PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
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| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| D050177 | Overweight |
| D000093763 | Intermittent Fasting |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D044343 | Overnutrition |
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Waitlist Control Group
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| Generalized Anxiety Disorder scale (GAD-7) | The Generalized Anxiety Disorder Assessment (GAD-7) is a seven-item questionnaire that is used to measure or assess the severity of generalized anxiety disorder (GAD). The GAD-7 has good reliability, criterion, construct, factorial, and procedural validity. The raw score ranges from 0 to 21. Increasing scores are associated with multiple domains of functional impairment. Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively. | Week 0, Week 4, Week 8 and Week 20 |
| Pittsburgh Sleep Quality Index (PSQI) | Change in sleep quality as measure by the Pittsburgh Sleep Quality Index (PSQI) global score. PSQI global score range is 0-21 with higher scores indicating more sleep disturbance. The Pittsburgh Sleep Quality Index (PSQI) is a widely used self-report questionnaire that assesses sleep quality over a one-month time interval. Nineteen individual items generate seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. A global PSQI score greater than 5 yielded a diagnostic sensitivity of 89.6% and specificity of 86.5% in distinguishing good and poor sleepers. | Week 0, Week 4, Week 8, Week 20 |
| Cognitive complaints in bipolar disorder rating assessment (COBRA) | The Cognitive Complaints in Bipolar Disorder Rating Assessment (COBRA) evaluates cognitive impairments which were perceived in daily living. It consists of 16-items using a 4-point Likert scale as follows for each item: 0 = never, 1 = sometimes, 2 = often, and 3 = always. The COBRA had a one-factor structure and showed high internal consistency. | Week 0, Week 4, Week 8, Week 20 |
| Patient-reported Outcome Measurement Information System (PROMIS) Cognitive Function Short Form 8a | Patient-reported Outcome Measurement Information System (PROMIS) Cognitive Function Short Form 8a is an 8-item self report questionnaire assess subjective cognitive difficulties regarding a patient's concentration, memory, language, mental acuity, as well as perceived changes in cognitive functioning. It has strong internal consistency reliability, supporting its use as a reliable measure of subjective cognitive functioning. This measure has seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, social functioning, sleep disturbance). The scale includes four items per domain, each scored from 1 to 5. The scale also includes one question at the end about pain intensity, which is scored from 0 to 10. The possible score ranges from 8 to 40. Higher scores indicate poorer outcomes. | Week 0, Week 4, Week 8, Week 20 |
| World Health Organization Disability Assessment Scale (WHODAS 2.0) | The adult self-administered version of the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) is a 36-item measure that assesses disability in adults age 18 years and older. It assesses disability across six domains, including understanding and communicating, getting around, self-care, getting along with people, life activities (i.e., household, work, and/or school activities), and participation in society. Each item is rated on a 5-point scale from 0 (none) to 4 (extreme or cannot do), with higher scores indicating greater disability. The total score is calculated by summing the item scores, which can then be converted into a standardized score ranging from 0 to 100, with higher scores indicating greater disability. | Week 0, Week 4, Week 8, Week 20 |
| The Altman Self-Rating Mania Scale (ASRM) | The Altman Self-Rating Mania Scale (ASRM) is a five-item scale that assesses mood, self-confidence, sleep disturbance, speech, and activity level over a week. The ASRM at a screening cutoff score of 5.5 has shown an optimal combination of sensitivity and specificity (85% and 86%, respectively). The ASRM score range from 5 to 25 with higher scores indicating greater severity of manic symptoms | Week 0, Week 4, Week 8, Week 20 |
| Changes in waist size | Measurements of the waist | Week 0, 8, and 20 |
| D009748 |
| Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005215 | Fasting |
| D005247 | Feeding Behavior |
| D001519 | Behavior |