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Behavioural Intervention

Healthy Lifestyles for Bipolar Disorder (HL Trial)

N/A

Recruiting

Led By Sheri L Johnson, PhD

Research Sponsored by University of California, Berkeley

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

I have not gained or lost more than 11 pounds in the last 3 months.

I have access to a smartphone.

Must not have

Have you been diagnosed with Schizophrenia?

Timeline

Screening 2 weeks

Treatment 8 weeks

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to compare the effects of two different healthy lifestyles on people with bipolar disorder. The trial will investigate the acceptability of time-restricted eating and the Mediterranean diet for those who are already taking

Who is the study for?

This trial is for individuals with bipolar disorder who are currently on medication. Participants will track their eating, sleep, and mood for two weeks before being randomly assigned to one of two healthy eating plans: time-restricted eating or the Mediterranean diet.

What is being tested?

The study aims to assess the acceptability and impact of time-restricted eating versus the Mediterranean diet on manic and depressive symptoms, as well as overall quality of life in people with bipolar disorder already receiving medication.

What are the potential side effects?

Since this trial focuses on dietary interventions rather than medications, side effects may include changes in weight, digestive discomfort or alterations in energy levels due to new eating patterns.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am currently receiving treatment for bipolar disorder.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Timeline

Screening ~ 2 weeks0 visits

Treatment ~ 8 weeks0 visits

Follow Up ~ 12 months0 visits

Screening ~ 2 weeks

Treatment ~ 8 weeks

Follow Up ~12 months

This trial's timeline: 2 weeks for screening, 8 weeks for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Acceptability

Adherence to Mediterranean Diet

Adherence to time-restricted eating

+6 more

Secondary study objectives

Daily emotional lability as assessed using ecological momentary assessment

Regularity of daily routines (Brief Social Rhythm Questionnaire)

Self-rated depression

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Time Restricted Eating (TRE) for 8 weeksExperimental Treatment1 Intervention

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.

Group II: Mediterranean diet for 8 weeksActive Control1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Time restricted eating

2021

N/A

~130

0 / 5Eligibility criteria met