CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 58 enrolled
Drug / intervention
Motivational Interviewing-Cognitive Behavioral Therapy Ketogenic Nutrition Adherence Program +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04817176
NCT04817176N/ACompleted

Pilot Trial of an Motivational Interviewing-Cognitive Behavioral Therapy Ketogenic Nutrition Adherence Program for Older Adults

Florida State University·interventional·Posted Mar 26, 2021·Updated Feb 14, 2025

In Brief

A clinical study evaluating Motivational Interviewing-Cognitive Behavioral Therapy Ketogenic Nutrition Adherence Program and Ketogenic Nutrition Program for Mild Cognitive Impairment and 2 related conditions. Completed, enrolled 58 participants across 1 site.

Detailed Summary

Objective 1: Assess feasibility and acceptability of all protocol components of a pilot trial testing a 6-week telehealth Mediterranean 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) to prepare for a full-scale trial. Specifically, the investigators will examine the feasibility of the recruitment, retention, assessment, and intervention delivery methods. The investigators hypothesize that: 1. The study protocol will result in high patient retention (90%) and patient attendance of intervention sessions (80%), and 2. A centralized MI-CBT telehealth delivery approach will be associated with high intervention acceptability ratings from patients. Objective 2: Assess signal of initial effect of the KNA program on important clinical outcomes and adherence relative to a KN information-only condition. The investigators hypothesize that patients in the KNA condition, relative to the KN-only condition, will show: 1. higher rates of clinically significant improvements on the RBANS total scale scores, improvements in daily functioning (FSQ), and decreases in patient CAIDE risk score( (Cardiovascular Risk Factors, Aging, and Incidence of Dementia), and 2. improved adherence to KN, as evidenced by higher levels of measurable urine ketones in the KNA condition compared to the KN-only condition.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20222023202420252026
First PostedMar 26, 2021
Enrollment StartSep 24, 2021
Primary CompletionJul 1, 2023
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 5.3 years ago

Interventions

Motivational Interviewing-Cognitive Behavioral Therapy Ketogenic Nutrition Adherence Programbehavioral

Experimental Arm: 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.

Ketogenic Nutrition Programother

Active Comparator Arm: 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.