N/A
Completed N=58
MI-CBT Adherence Program for Lifestyle Interventions in Older Adults
Mild Cognitive Impairment · Adherence, Patient · Ketosis
Source: ClinicalTrials.gov NCT04817176 ↗
Enrolled (actual)
58
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcomePrimary: Retention — 90.6; 76.6 percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Retention |
90.6; 76.6 | — |
| PRIMARY Acceptability |
3.65; 3.6 | — |
| PRIMARY Ketosis (Adherence) |
17.32; 10.54 | — |
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT04817176). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.