Healthy Lifestyles for Bipolar Disorder

Part of paid clinical trials in Berkeley, California.

Sponsor
University of California, Berkeley
Study ID
NCT06188754
Status
Recruiting
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Conditions

  • Diet, Mediterranean
  • Time Restricted Eating

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Time restricted eating — BEHAVIORAL
    Limiting food intake to 10 hours per day
  • Mediterranean diet — BEHAVIORAL
    Dietary advice designed to improve consumption of vegetables, fruits, whole grains, and the use of olive oil.

Study Details

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.

Key Dates

Start date
Jun 5, 2024
Status verified
Feb 2025
Primary completion
Dec 28, 2028
Completion
Feb 28, 2029

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Time Restricted Eating (TRE) for 8 weeks
    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.
  • Active Comparator: Mediterranean diet for 8 weeks
    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.

Primary Outcome Measure

Acceptability [ Time Frame: immediately post-treatment (10 weeks after enrollment) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of CaliforniaBerkeleyCalifornia94720
Sheri L Johnson
[email protected]
415-347-6755

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By research site
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