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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07116226
Acronym
LIVE IT~LAUNCH
Enrollment
40
Registered
2025-08-11
Start date
2025-08-01
Completion date
2026-07-01
Last updated
2026-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Medical Keto Diet

Keywords

Medical Ketogenic Diet

Brief summary

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)

Detailed 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.

Interventions

OTHERMedical Keto Education Program

4 hour asynchronous educational class

Sponsors

University of Maryland, Baltimore
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 74 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

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

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORDeanna L Kelly, PharmD, BCPP

University of Maryland, Baltimore

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 21, 2026