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NCT04817176 · ClinicalTrials.gov registry record · NA
MI-CBT Adherence Program for Lifestyle Interventions in Older Adults
A NA study, sponsored by Florida State University.
- Completed
- Registry status
- NA
- Development phase
- 58
- Enrollment target
NCT04817176: Completed NA study, sponsored by Florida State University.
NCT04817176 is a NA study that has completed, run by Florida State University. The registered enrollment target is 58 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04817176, a NA study, has completed, sponsored by Florida State University.
- COMPLETED
- Registry status
- NA
- Development phase
- 58 participants
- Enrollment target
Study 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.
Primary Outcome
Retention in the clinical intervention as assessed by percent of attendance at the intervention groups
Interventions
- BEHAVIORAL Motivational Interviewing-Cognitive Behavioral Therapy Ketogenic Nutrition Adherence Program
- OTHER Ketogenic Nutrition Program
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 58 participants |
| Start Date | 2021-09-24 |
| Est. Completion | 2023-07-01 |
| Phase | NA |
What the finished NCT04817176 record still lists
NCT04817176 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 58 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which Motivational Interviewing-Cognitive Behavioral Therapy Ketogenic Nutrition Adherence Program is the first listed.
NCT04817176 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04817176 about?
NCT04817176 is a clinical study titled "MI-CBT Adherence Program for Lifestyle Interventions in Older Adults". 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 fo...
What is the current status of trial NCT04817176?
This trial is currently completed. It is a NA study. The enrollment target is 58 participants. The study started on 2021-09-24. Estimated completion is 2023-07-01.
What interventions are being tested in trial NCT04817176?
The interventions under investigation include: Motivational Interviewing-Cognitive Behavioral Therapy Ketogenic Nutrition Adherence Program (BEHAVIORAL), Ketogenic Nutrition Program (OTHER).
Who is sponsoring clinical trial NCT04817176?
This trial is sponsored by Florida State University, which has 219 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04817176's enrollment target sits among peer trials
58 1256th of 2000 higher than 740 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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