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MI-CBT KNA Program for Ketosis (MI-CBT KNAP Trial)

Phase < 1
Waitlist Available
Led By Julia L Sheffler, PhD
Research Sponsored by Florida State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6-weeks
Awards & highlights

MI-CBT KNAP Trial Summary

This trial is testing a 6-week telehealth ketogenic nutrition adherence (KNA) program using motivational interviewing and cognitive behavioral strategies (MI-CBT) compared to a KN information only group for older adults with mild cognitive impairment (MCI) in a community senior health clinic.

Eligible Conditions
  • Ketosis
  • Patient Adherence
  • Mild Cognitive Impairment

MI-CBT KNAP Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6-weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6-weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Acceptability
Ketosis (adherence)
Retention
Secondary outcome measures
Clinical signal of effect
Other outcome measures
Pain intensity

MI-CBT KNAP Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: MI-CBT KNA ProgramExperimental Treatment1 Intervention
The program is a 6-week group, telehealth intervention for older adults with possible MCI. The intervention uses Motivational interviewing and cognitive behavioral therapy strategies to enhance motivation and help participants overcome personal obstacles to following health-behavior recommendations. Specifically, the program examines the use of a Mediterranean ketogenic type of nutrition to target mild cognitive impairment. The intervention is designed to disseminate practical information to help older adults learn how to incorporate healthy Mediterranean ketogenic nutrition into their lifestyle.
Group II: KN Information-Only ProgramActive Control1 Intervention
6-week group, telehealth intervention for older adults. The intervention is designed to disseminate practical information to help older adults learn how to incorporate healthy Mediterranean ketogenic nutrition into their lifestyle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Motivational Interviewing-Cognitive Behavioral Therapy Ketogenic Nutrition Adherence Program
2021
Completed Early Phase 1
~70

Find a Location

Who is running the clinical trial?

Florida State UniversityLead Sponsor
198 Previous Clinical Trials
30,633 Total Patients Enrolled
Julia L Sheffler, PhDPrincipal InvestigatorFlorida State University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are recruitment efforts underway for this experiment?

"According to clinicaltrials.gov, this trial is not actively recruiting candidates at present. Initially posted on September 24th 2021 and last amended on the 6th of September 2022; however, there are currently over 600 other studies that are searching for participants."

Answered by AI

What criteria must be met for someone to qualify as a participant in this trial?

"In order to be eligible for this experiment, potential participants should present with ketosis and fall in the age range of 60-85 years. The trial is accepting a total of sixty people into its cohort."

Answered by AI

Is this trial accessible to adults aged 18 and over?

"According to the criteria, only individuals aged 60 - 85 can join this trial. There are 28 studies for ages 18 and under, whereas 560 trials exist for those over 65 years old."

Answered by AI

Who else is applying?

What state do they live in?
Wisconsin
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
MI-CBT Adherence Program for Lifestyle Interventions in Older Adults
Julia Sheffler 2021. "MI-CBT Adherence Program for Lifestyle Interventions in Older Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04817176.
~16 spots leftby Apr 2025
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