Trial Outcomes & Findings for KNA Proof-of-Concept (NCT NCT04968041)

Last Updated: 2024-03-01

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

10 participants

Primary outcome timeframe

6-weeks

Results posted on

2024-03-01

Participant Flow

Participant milestones

Participant milestones
Measure	MI-CBT KNA Program 6-week group intervention using MI and CBT strategies to promote adherence to a ketogenic nutrition program. 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.
Overall Study STARTED	10
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

KNA Proof-of-Concept

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MI-CBT KNA Program n=10 Participants 6-week group intervention using MI and CBT strategies to promote adherence to a ketogenic nutrition program. 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.
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=93 Participants
Age, Categorical >=65 years	9 Participants n=93 Participants
Age, Continuous	70.44 years STANDARD_DEVIATION 3.05 • n=93 Participants
Sex: Female, Male Female	2 Participants n=93 Participants
Sex: Female, Male Male	8 Participants n=93 Participants
Race/Ethnicity, Customized White Non-Hispanic	5 Participants n=93 Participants
Race/Ethnicity, Customized Black	2 Participants n=93 Participants
Race/Ethnicity, Customized Latino/Hispanic	3 Participants n=93 Participants
Region of Enrollment United States	10 Participants n=93 Participants
Repeatable Battery for Assessment of Neuropsychological Status (RBANS-Update)	89.78 units on a scale STANDARD_DEVIATION 9.135 • n=93 Participants
Adherence	8.56 units on a scale STANDARD_DEVIATION 1.87 • n=93 Participants

PRIMARY outcome

Timeframe: 6-weeks

Outcome measures

Outcome measures
Measure	MI-CBT KNA Program n=9 Participants 6-week group intervention using MI and CBT strategies to promote adherence to a ketogenic nutrition program. 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.
Ketogenic Adherence	8 Participants

PRIMARY outcome

Timeframe: 6-weeks

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).

Outcome measures

Outcome measures
Measure	MI-CBT KNA Program n=9 Participants 6-week group intervention using MI and CBT strategies to promote adherence to a ketogenic nutrition program. 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.
Acceptability All goals	3 Participants
Acceptability Most	1 Participants
Acceptability Some	5 Participants

PRIMARY outcome

Timeframe: baseline to 6-weeks

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

Outcome measures

Outcome measures
Measure	MI-CBT KNA Program n=9 Participants 6-week group intervention using MI and CBT strategies to promote adherence to a ketogenic nutrition program. 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.
Retention	9 Participants

SECONDARY outcome

Timeframe: Baseline and 6-weeks

Assessed using the total scaled score (age-normed) of the Repeatable Battery for the Assessment of Neuropsychological Status - Update. A score of 100 is considered "average" (50th percentile), and higher scores are considered better cognitive functioning. The outcome reported is the actual value at 6-weeks, rather than a change score.

Outcome measures

Outcome measures
Measure	MI-CBT KNA Program n=9 Participants 6-week group intervention using MI and CBT strategies to promote adherence to a ketogenic nutrition program. 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.
Cognitive Functioning	97.11 score on a scale Standard Deviation 11.14

Adverse Events

MI-CBT KNA Program

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Julia Sheffler

Florida State University

Phone: 850-644-4199

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place