KNA Proof-of-Concept

NCT04968041 | Completed Results

• 1 other identifier: STUDY00000111
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The intervention program proof-of-concept was assessed as a single-arm, within-subjects clinical study with a target enrollment of 10 participants with possible or probable amnestic MCI. The protocol required participants to complete a pre-intervention assessment within two weeks of beginning the intervention, attend seven, one-hour intervention group sessions across six weeks, complete a post-assessment and interview in the final week of the intervention, and complete weekly surveys throughout the intervention.

Conditions

Adherence, Treatment; Retention; Cognitive Impairment, Mild

Outcome Measures

Primary Outcomes (3)

• Ketogenic Adherence

  Assessed based on reported ketone levels during the program (reporting at least one day or greater with trace amounts of ketones) using urinalysis ketone test strips administered at home by participants.

  6-weeks

• Acceptability

  Assessed based on qualitative feedback and online surveys described here: https://pilotfeasibilitystudies.biomedcentral.com/articles/10.1186/s40814-022-00970-z. Participants also rated how well they felt the program helped them achieve their health-related goals 0 (none) to 3 (all).

  6-weeks

• Retention

  Assessed based on attendance and % of participants who remained in the program from start to finish

  baseline to 6-weeks

Secondary Outcomes (1)

• Cognitive Functioning

  Baseline and 6-weeks

Study Arms (1)

MI-CBT KNA Program

EXPERIMENTAL

6-week group intervention using MI and CBT strategies to promote adherence to a ketogenic nutrition program.

Behavioral: Motivational Interviewing-Cognitive Behavioral Therapy Ketogenic Nutrition Adherence Program

Interventions

Motivational Interviewing-Cognitive Behavioral Therapy Ketogenic Nutrition Adherence Program BEHAVIORAL

The intervention using strategies from motivational interviewing and cognitive behavioral therapy to promote motivation and adherence to ketogenic nutrition in older adults at high risk for Alzheimer's disease. The program is a 6-week, group program led by a psychologist and nutrition expert.

Also known as: MI-CBT KNA Program

MI-CBT KNA Program

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Presence of severe and/or unstable medical conditions
• diagnosable major neurocognitive disorder

Sponsors & Collaborators

• Florida State University: lead

Study Sites (1)

Florida State University

Tallahassee, Florida, 32306, United States

Location

Related Publications (1)

• Sheffler JL, Arjmandi B, Quinn J, Hajcak G, Vied C, Akhavan N, Naar S. Feasibility of an MI-CBT ketogenic adherence program for older adults with mild cognitive impairment. Pilot Feasibility Stud. 2022 Jan 22;8(1):16. doi: 10.1186/s40814-022-00970-z.

  PMID: 35065656 DERIVED

MeSH Terms

Conditions

Treatment Adherence and Compliance; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Julia Sheffler
• Organization: Florida State University

julia.sheffler@med.fsu.edu

850-644-4199

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 13, 2021
• First Posted: July 20, 2021
• Study Start: September 27, 2019
• Primary Completion: June 30, 2020
• Study Completion: August 30, 2020
• Last Updated: March 1, 2024
• Results First Posted: March 1, 2024

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)