Learning How to Implement and Use a Ketogenic Diet to Improve Mental Health
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- 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)
Study Overview
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:
- Mastery Class (Education, Q & A)
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 74 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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)
Arms & Interventions
Medical Keto Mastery Class
Intervention: Medical Keto Education Program (Other)
Outcomes
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Deanna Kelly
Professor
University of Maryland, Baltimore