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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 is a NA study that has completed, run by Florida State University. The registered enrollment target is 58 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04817176
The ClinicalTrials.gov registry entry for NCT04817176 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 58 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Florida State University, which has 219 total studies on file at ClinicalTrials.gov.
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 reports 0 study locations.
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.
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