MI-CBT Adherence Program for Lifestyle Interventions in Older Adults

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.

Conditions

• Mild Cognitive Impairment
• Adherence, Patient
• Ketosis

Interventions

BEHAVIORAL

Motivational Interviewing-Cognitive Behavioral Therapy Ketogenic Nutrition Adherence Program

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.

OTHER

Ketogenic Nutrition Program

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.

Sponsors & Collaborators

• National Institute on Aging (NIA)

  collaborator NIH

• Florida State University

  lead OTHER

Principal Investigators

• Julia L Sheffler, PhD · Florida State University

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

60 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-09-24

Primary Completion

2023-07-01

Completion

2023-07-01

Countries

• United States

Study Locations