Active, Not Recruiting

NCT Number: NCT07116226

Learning How to Implement and Use a Ketogenic Diet to Improve Mental Health

The goal of the study is to implement a team-based "train the trainer" group approach by providing participants education and the opportunity for self-implementing a medical ketogenic diet study for 4 weeks.

The overarching goal of the program is for those participating to be able to initiate the diet in clinical and research settings with greater competence.

The study has two parts:

1. Mastery Class (Education, Q & A) 2. 4 Week Open Label LIVE IT ketogenic diet participation with private and group consultation (optional)

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Medical Keto Diet

Age range

18 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maryland Psychiatric Research Center (MPRC)

Catonsville, Maryland, 21228, United States

About this study

There will be two parts to assist with a train the trainer approach: 1) an educational component (4-hour mastery class, 2 Q&A 1.5 hours) with related materials and 2) an open label cohort study providing the opportunity for participants to attempt the medical ketogenic diet within a group for 4 weeks with private and group counseling.

By participating in a 4-week self-implemented diet within a group setting our hope is to increase competence in implementing the diet and monitoring its success with KetoMojo. Secondarily, those who participate in the cohort study may have improvements in their own physical health and mental well-being.

After the 4 hour mastery class is completed an additional two weeks is given prior to the group keto diet starting to ensure all dietician meetings are completed.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Ages 18-74 years
Not currently on a ketogenic diet
No prior experience in successfully implementing a medical ketogenic diet for self
Clinician, researcher or clinical or research team member

Exclusion criteria

Age 18-74 years
Body mass index > 18.5
Not currently on a ketogenic diet (Self report)
No prior experience in successfully implementing a medical ketogenic diet for self (Self report)

Treatment and study plan

Medical Keto Education Program

Other

4 hour asynchronous educational class

Primary outcomes

Change in individual competence in understanding the nutritional aspects and food selection of a medical keto diet. Competence will be measured by pre- and post-education and post- LlVE IT experience (optional)

Time frame: 12 weeks

This will be assessed with16 items answerable along a Visual Analog scale each with scores from 0-100mm with higher scores demonstrating better competence.

Sponsors and collaborators

Lead sponsor

University of Maryland, Baltimore