MI-CBT Adherence Program for Lifestyle Interventions in Older Adults
Public ClinicalTrials.gov record NCT04817176. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Pilot Trial of an Motivational Interviewing-Cognitive Behavioral Therapy Ketogenic Nutrition Adherence Program for Older Adults
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT04817176
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 58 participants
Conditions and interventions
Conditions
Interventions
- Motivational Interviewing-Cognitive Behavioral Therapy Ketogenic Nutrition Adherence Program Behavioral
- Ketogenic Nutrition Program Other
Behavioral · Other
Eligibility (public fields only)
- Age range
- 60 Years to 85 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 24, 2021 (Actual)
- Primary completion
- Jul 1, 2023 (Actual)
- Completion
- Jul 1, 2023 (Actual)
- Last update posted
- Feb 14, 2025
2021 – 2023
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Florida State University | Tallahassee | Florida | 32310 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04817176, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 14, 2025 · Synced Oct 18, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04817176 live on ClinicalTrials.gov.