Healthy Lifestyles for Bipolar Disorder

NCT06188754 | Recruiting DMC

• 1 other identifier: Healthy Lifestyles 01
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to compare the effects of two different healthy lifestyles on outcomes for those with bipolar disorder. The goals are to understand the acceptability of time-restricted eating and the mediterranean diet for those who are already receiving medication treatment for bipolar disorder, and to consider how these two food plans predict changes in manic symptoms, depressive symptoms, and Quality of Life. Participants will complete daily measures of eating, sleep and mood for two weeks, and then will be assigned to follow one of the two food plans for eight weeks. The investigators will measure symptoms and Quality of Life at baseline and during and after the food plan.

Conditions

Time Restricted Eating; Diet, Mediterranean

Keywords

bipolar disorder; sleep; circadian rhythm

Outcome Measures

Primary Outcomes (9)

• Acceptability

  Participant self-ratings of the acceptability of the intervention: The primary index of acceptability will be the percentage of individuals who endorse that they agree or strongly agree that they would recommend the food plan to a friend. This single item has been used in previous trials of bipolar disorder. Higher agreement will be considered a positive outcome.

  immediately post-treatment (10 weeks after enrollment)

• Adherence to time-restricted eating

  Adherence will be scored based on the time of their first and final calorie consumption each day during the 8 week intervention. The investigators will select entries from the time interval that contains 95% of intake events. Following standards in other US and European studies of TRE, the investigators will focus on days in which participants adequately logged (e.g., entered at least two intake events, covering at least a 5 hour window), and will calculate the percentage of days in which individuals met the eating window goal. High adherence will be defined as meeting this standard on at least 78% of days logged. As supplemental data, the investigators will report the percentage of days logged, and the percentage of days in which individuals logged adequately and followed the planned window.

  Average number of daily food logs showing adherence across the 8-week intervention

• Adherence to Mediterranean Diet

  Adherence will be scored based on a Food Frequency Questionnaire that we developed for this study. We will score this using the Adherence to the Mediterranean Diet scoring system (AMed), which provides up to 9 points based on above-median consumption of beneficial foods (e.g., fruits and vegetables) and below median consumption of "extras" such as alcohol. Higher scores reflect better adherence to the mediterranean diet.

  Average number of food logs showing adherence at or above the median for 2 days at the mid-point of treatment (week 6) and at the end of treatment (week 10)

• Mania

  Decline in Young Mania Rating Scale (YMRS) total scores, completed by a blind rater

  Lower YMRS at the end of intervention (10 weeks) as compared to baseline

• Depression

  Decline in Montgomery Asberg Depression Scale (MADRS) total scores, completed by a blind rater

  Lower MADRS at the end of intervention (10 weeks) as compared to baseline

• Self-rated Quality of Life (QOL)

  Higher scores on the self-rated Brief Quality of Life in Bipolar Disorder (QoL.BD) at 1.5-months post intervention as compared to baseline

  Scores at 1.5-months post-intervention (16 weeks after study entry) as compared to baseline

• Mania at follow-up

  Sustained lower YMRS scores across follow-up

  YMRS scores will be lower at 3, 6, 12 month post-intervention follow-ups as compared to baseline

• Depression at follow-up

  Sustained lower MADRS scores across follow-up

  MADRS scores will be lower at 3, 6, 12 month post-intervention follow-ups as compared to baseline

• QOL at follow-up

  Sustained higher Brief QOL.BD scores

  Brief QOL.BD scores will be higher at 6- and 12-month post-intervention follow-ups as compared to baseline

Secondary Outcomes (8)

• Self-rated mania

  at post-intervention (10 weeks) and at 1.5, 3, 6, and 12 month follow-ups post-intervention, as compared to baseline

• Self-rated depression

  at post-intervention (10 weeks) and at 1.5, 3, 6, and 12 month follow-ups post-intervention, as compared to baseline

• Sleep hygiene behaviors

  post-intervention (10 weeks) as compared to baseline

• Weekly change in mania severity

  Weekly scores from the end of the intervention through one-year post-intervention follow-up

• Sleep disturbance and sleep impairment

  post-treatment (10 weeks) as compared to baseline

Study Arms (2)

Time Restricted Eating (TRE) for 8 weeks

EXPERIMENTAL

Participants will receive an intro to TRE and then throughout 8 weeks they will receive brief online psychoeducation several times per week with optional weekly coaching sessions. TRE involves restricting the window of eating to 10 hours/ day, most typically by avoiding eating in the first 1-2 hours after awakening and in the 2-4 before sleep. Those with an eating window \> 14 hours will be asked to restrict their eating to 12 hours in the first week, then 10 hours in week 2. To select the period, investigators will ask Ss to review baseline logs to consider sleep, eating, family meals and social commitment schedules, and any special energy demands, such as exercise. During the eating window, no restrictions are placed on the type or quantity of food consumed. The investigators will instruct participants to follow their habitual diet within their 10-hour eating window and to aim to consume the same number of calories per day as they did at baseline.

Behavioral: Time restricted eating

Mediterranean diet for 8 weeks

ACTIVE COMPARATOR

Participants will receive a several page introduction to the mediterranean diet, and then will receive support throughout the 8 week intervention to follow this food plan, including brief online psychoeducation that will be sent several times per week, and optional weekly coaching sessions. The mediterranean diet is a plan for healthy eating based on how people eat in the mediterranean region. Individuals will be encouraged to consume vegetables (6 servings/day), fruits (2-4 servings/day), whole grains (daily), legumes (3-4 times per week), nuts (.5 oz per day), and oily fish (2 servings/week). Participants will be encouraged to choose lean meats and other sources of protein over red meat and processed meats. Sweets, refined cereals, alcohol, and wine or alcohol will be labelled as extras, and participants will be encouraged to limit consumption of extras.

Behavioral: Mediterranean diet

Interventions

Time restricted eating BEHAVIORAL

Limiting food intake to 10 hours per day

Also known as: intermittent fasting

Time Restricted Eating (TRE) for 8 weeks

Mediterranean diet BEHAVIORAL

Dietary advice designed to improve consumption of vegetables, fruits, whole grains, and the use of olive oil.

Mediterranean diet for 8 weeks

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• meets diagnostic criteria for bipolar I disorder or bipolar II disorder (but not cyclothymia, BD Not otherwise specified or BD due to another medical condition)
• current sleep (insomnia, hypersomnolence) or circadian sleep-wake (delayed phase, advanced phase, irregular sleep-wake, non-24-hour sleep-wake-type) concerns indicated by endorsement of at least some sleep or circadian-related impairment across the screening self-reports or interview
• Living in an English-speaking country (and one that we have expertise in research procedures and diet)
• Has been speaking English for at least 10 years, speaks English in the home, or certifies that they are able to understand English well for the study and demonstrates this during the screening interview.
• Receiving medical care for BD (referrals will be provided for those who would like to begin care)
• Mood-stabilizing medication regimens stable for at least one month
• \< 5 kg weight change in the past 3 months
• Currently eating ≥ 12 hours per day at least twice per week
• Able to operate the camera function and respond to web-based surveys by phone (loaner phones will be provided as needed)
• Not engaged in current shift work or have other responsibilities such as providing care that would chronically disrupt their sleep (i.e., \> 3 h between 22:00 and 05:00 h for at least 1 day/week)
• Able to complete 7 days of dietary logs adequately (e.g., at least 2 entries per day, covering at least a 5-hour eating window) during the baseline period
• Able to complete screening and baseline questionnaires adequately (e.g., not failing more than 1 attention check item with instructed responding; responding to standard multiple-choice items in a mean of \< 2 seconds per item). Where individuals respond to more than 14 items in a row with the same response, we will manually review for possible invalidity.

You may not qualify if:

• Current episode of depression, hypomania or mania, or psychosis (assessed by the aDiagnostic Interview for Anxiety, Mood, and Obsessive-compulsive and Related Neuropsychiatric Disorders; DIAMOND), Participants with acute mood disorder episodes will be encouraged to seek treatment and to consider the study when symptoms have remitted.
• Eating disorder diagnosis (by self-report of treatment or diagnosis at any point during their life, Short Eating Disorder Examination Questionnaire (EDE-QS) scores above clinical concern thresholds for eating disorders, or DIAMOND interview of symptoms during adulthood)
• Past 3-month alcohol use disorder or substance use disorder (assessed by DIAMOND)
• Active suicidal ideation coupled with plan, intent or attempt history as assessed by Columbia Suicide Severity Rating Scale
• Conditions that would interfere with ability to take part in the intervention , including pregnancy, breastfeeding, uncorrected hypo or hyperthyroidism, gastrointestinal conditions impairing nutrient absorption,
• Medical conditions such as HIV, AIDS, lupus, or multiple sclerosis that could confound the assessment of mania or other measures
• Cognitive deficits as noted during the initial interview or as indicated by low performance on the Short Orientation Memory Concentration Test (\< 20 on the weighted score).

Sponsors & Collaborators

• University of California, Berkeley: lead
• University College, London: collaborator
• Swinburne University of Technology: collaborator
• Deakin University: collaborator
• University of British Columbia: collaborator
• Salk Institute for Biological Studies: collaborator
• Wellcome Trust: collaborator

Study Sites (1)

University of California

Berkeley, California, 94720, United States

RECRUITING

Related Publications (1)

• Johnson SL, Murray G, Kriegsfeld LJ, Manoogian ENC, Mason L, Allen JD, Berk M, Panda S, Rajgopal NA, Gibson JC, Joyner KJ, Villanueva R, Michalak EE. A randomized controlled trial to compare the effects of time-restricted eating versus Mediterranean diet on symptoms and quality of life in bipolar disorder. BMC Psychiatry. 2024 May 18;24(1):374. doi: 10.1186/s12888-024-05790-4.

  PMID: 38762486 DERIVED

MeSH Terms

Conditions

Intermittent Fasting; Bipolar Disorder

Interventions

Diet, Mediterranean

Condition Hierarchy (Ancestors)

Fasting; Feeding Behavior; Behavior; Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Sheri L Johnson, PhD

  University of California, Berkeley

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sheri L Johnson, PhD

CONTACT

(510) 519-4305; calmprogram@berkeley.edu

Nandini Rajgopal, BS

CONTACT

(510) 519-4305; calmprogram@berkeley.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes will be assessed by an interviewer who is unaware of treatment condition.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned to take part in either time-restricted eating or the Mediterranean diet.

Study Record Dates

• First Submitted: December 18, 2023
• First Posted: January 3, 2024
• Study Start: June 5, 2024
• Primary Completion (Estimated): December 28, 2028
• Study Completion (Estimated): February 28, 2029
• Last Updated: February 6, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: De-identified data will be shared within one year after data collection ends.
• Access Criteria: Data will be available publically through Open Science Foundation upon request. We will also comply with Wellcome Trust guidance for data sharing.

Locations

US (1)