KNA Proof-of-Concept

NCT04968041 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2024-03-01

Study results available
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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

Interventions

BEHAVIORAL

Motivational Interviewing-Cognitive Behavioral Therapy Ketogenic Nutrition Adherence Program

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.

Sponsors & Collaborators

  • Florida State University

    lead OTHER

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
60 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-09-27
Primary Completion
2020-06-30
Completion
2020-08-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04968041 on ClinicalTrials.gov