Evidence map›Paper›PMID 35065656›Full record

ArticlePilot and feasibility studies2022

Feasibility of an MI-CBT ketogenic adherence program for older adults with mild cognitive impairment.

Julia L Sheffler, Bahram Arjmandi, Jamie Quinn, Greg Hajcak, Cynthia Vied, Neda Akhavan, Sylvie Naar

Registry-linked trialOpen access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Pilot and feasibility studies, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04968041 (Feasibility Trial Assessing Adherence and Response to a Ketogenic Dietary Intervention for Individuals at High Risk for Alzheimer's Disease), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.6field-weighted citation impact, top 36% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04968041 nacompletednot on this map

Feasibility Trial Assessing Adherence and Response to a Ketogenic Dietary Intervention for Individuals at High Risk for Alzheimer's Disease

TypeinterventionalSponsorFlorida State UniversityRan2019 to 2020Enrolled10ConditionsAdherence, Treatment, Retention, Cognitive Impairment, MildArmsMotivational Interviewing-Cognitive Behavioral Therapy Ketogenic Nutrition Adherence Program
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 6 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Article
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 1 institution in 1 country.

Julia L ShefflerFlorida State University, Tallahassee, USA. Julia.sheffler@med.fsu.edu.ORCID http://orcid.org/0000-0002-9784-1134
Bahram ArjmandiFlorida State University, Tallahassee, USA.
Jamie QuinnFlorida State University, Tallahassee, USA.
Greg HajcakFlorida State University, Tallahassee, USA.
Cynthia ViedFlorida State University, Tallahassee, USA.
Neda AkhavanFlorida State University, Tallahassee, USA.
Sylvie NaarFlorida State University, Tallahassee, USA.
Florida State University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe National Institutes of Health Obesity-Related Behavioral Intervention Trials model for intervention development was used to establish the feasibility and proof of concept of a motivational ketogenic nutrition adherence program for older adults with mild cognitive impairment.

methodsThis was a single-arm, single-center feasibility trial. A comprehensive assessment protocol, including a clinical interview, neuropsychological testing, and genetic sequencing was used as an initial screening. Nine participants (aged 64-75) with possible amnestic mild cognitive impairment were consented for the intervention. Participants completed pre- and post-intervention neuropsychological assessments using the updated Repeatable Battery for Assessment of Neuropsychological Status. Participants tracked their macronutrient consumption using food diaries and ketone levels using urinalysis test strips daily. Mood and other psychosocial variables were collected through surveys, and qualitative exit interviews were completed.

results100% of participants who began the trial completed the 6-week ketogenic nutrition adherence program, including completion of the pre- and post-assessments. Eight participants achieved measurable levels of ketones during the program. The average self-rated adherence across the program was 8.7 out of 10. A Wilcoxon Signed-Rank test demonstrated significant improvement in cognitive performance from baseline (median = 88) to follow up (median = 96, Z = - 2.26, p = .024). The average difference in cognitive performance from baseline to follow-up was - 7.33 (95% CI - 12.85, - 1.82).

conclusionsResults supported the feasibility for moving to the next phase and demonstrated proof of concept for the intervention. The next step is a randomized pilot trial to test clinical signals of effect compared to a control condition.

trial registrationThis trial was retrospectively registered with clinicaltrials.gov on July 13, 2021. The trial number is NCT04968041.

Indexed as

AdherenceCognitive Behavioral therapyInterventionMild cognitive impairmentMotivational interviewing

Identifiers

PMID35065656
PMCPMC8783179
OpenAlexW4206981424

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.