Learning How to Implement and Use a Ketogenic Diet to Improve Mental Health (LIVE IT~LAUNCH)

University of Maryland Baltimore (UMB)

Status: Invitation-only

Conditions: Medical Keto Diet

Treatments: Other: Medical Keto Education Program

Study type: Interventional

Funder types: Other

Identifiers

NCT07116226

HP-00113852

Details and patient eligibility

About

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)

Full description

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 74 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

40 participants in 1 patient group

Medical Keto Mastery Class

Experimental group

Treatment:

Other: Medical Keto Education Program