MI-CBT Adherence Program for Lifestyle Interventions in Older Adults

NCT04817176 | Completed Results

• 2 other identifiers: 1KL2TROO1429P30AG059297
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief 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. 1.The study protocol will result in high patient retention (90%) and patient attendance of intervention sessions (80%), and
2. 2.A centralized MI-CBT telehealth delivery approach will be associated with high intervention acceptability ratings from patients.
3. 3.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
4. 4.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

Outcome Measures

Primary Outcomes (3)

• Retention

  Retention in the clinical intervention as assessed by percent of attendance at the intervention groups

  6-weeks

• Acceptability

  Acceptability will be assessed using the Client Satisfaction Questionnaire - 8, item 1, rated 1 (poor) - 4 (excellent) (How would you rate the quality of service you received?).

  6-weeks

• Ketosis (Adherence)

  Participants will show measurable levels of ketones using at-home urinalysis test strips by week 5 of the intervention, as evidenced by greater than trace amounts of ketones on the urine test strips (i.e., \>5mg/dl).

  5 weeks

Other Outcomes (1)

• Brief Pain Inventory, Pain Intensity Scale

  6 weeks

Study Arms (2)

MI-CBT KNA Program

EXPERIMENTAL

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.

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

KN Information-Only Program

ACTIVE COMPARATOR

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.

Other: Ketogenic Nutrition Program

Interventions

Motivational Interviewing-Cognitive Behavioral Therapy Ketogenic Nutrition Adherence Program BEHAVIORAL

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.

MI-CBT KNA Program

Ketogenic Nutrition Program OTHER

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.

Also known as: KN Information-Only

KN Information-Only Program

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 60-85 years
• Meets criteria for possible mild cognitive impairment
• Telephone MoCA Score of greater than 12
• Reports interest in participating in the described nutrition intervention
• English speaking
• Has internet access with video conferencing capability and access to a computer, iPad, or other tablet.

You may not qualify if:

• Major, unstable health or psychiatric conditions, including: Type 1 diabetes, major neurocognitive disorders, schizophrenia, bipolar I disorder, or active psychosis
• Under-weight based on BMI
• Prescribed medications that may interact with ability to adhere to KN, including: insulin, monoamine oxidase inhibitors (MAOIs), or immunosuppressants
• Deemed unable to provide consent based on telephone cognitive screener with a licensed psychologist.

Sponsors & Collaborators

• Florida State University: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Florida State University

Tallahassee, Florida, 32310, United States

Location

Related Publications (2)

• Sheffler JL, Kiosses DN, He Z, Arjmandi BH, Akhavan NS, Klejc K, Naar S. Improving Adherence to a Mediterranean Ketogenic Nutrition Program for High-Risk Older Adults: A Pilot Randomized Trial. Nutrients. 2023 May 16;15(10):2329. doi: 10.3390/nu15102329.

  PMID: 37242211 RESULT

• Klejc K, Cruz-Almeida Y, Sheffler JL. Addressing Pain Using a Mediterranean Ketogenic Nutrition Program in Older Adults with Mild Cognitive Impairment. J Pain Res. 2024 May 23;17:1867-1880. doi: 10.2147/JPR.S451236. eCollection 2024.

  PMID: 38803693 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction; Patient Compliance; Ketosis

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Acidosis; Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Dr. Julia Sheffler
• Organization: Florida State University College of Medicine

julia.sheffler@med.fsu.edu

850-644-4199

Study Officials

• Julia L Sheffler, PhD

  Florida State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: March 23, 2021
• First Posted: March 26, 2021
• Study Start: September 24, 2021
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: February 14, 2025
• Results First Posted: February 14, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)