KNA Proof-of-Concept
Condition: Adherence, Treatment; Retention; Cognitive Impairment, Mild
MeSH terms: Cognitive Dysfunction
Study type: Interventional

Summary: 
      The intervention program proof-of-concept was assessed as a single-arm, within-subjects
      clinical study with a target enrollment of 10 participants with possible or probable amnestic
      MCI. The protocol required participants to complete a pre-intervention assessment within two
      weeks of beginning the intervention, attend seven, one-hour intervention group sessions
      across six weeks, complete a post-assessment and interview in the final week of the
      intervention, and complete weekly surveys throughout the intervention.
    

Detailed description: 
      The primary goal of the proof-of-concept phase is to use pre-post comparisons to determine if
      the treatment package can produce clinically significant improvements. Thus, our goal was to
      assess whether the MI-CBT KNA program influenced adherence to KN and cognitive outcomes. Of
      note, recruitment for the trial occurred in the weeks leading up to the COVID-19 pandemic,
      which substantially altered the original intervention and assessment design due to
      restrictions on in-person human subject research. While the original protocol included
      in-person assessments and group meetings, collection of multiple biological samples (i.e.,
      lipid panels, basic vitals, inflammatory biomarkers), and weekly health assessments, these
      in-person components were modified or removed for completion during the COVID-19 pandemic.
      Pre-assessment and screening appointments described below were completed in-person prior to
      the COVID-19 pandemic. Thus, we completed pre-intervention neuropsychological assessments
      with participants at baseline prior to beginning the trial; however, immediately following
      baseline assessments, we fully revised the protocol to include only online, video, and phone
      contact. We moved the KNA program to an online platform (HIPAA-compliant Zoom), and
      assessments were changed to online surveys and video assessments. Individual testing of the
      video platform was completed prior to the trial, which successfully reduced technical
      problems.

      The MI-CBT KNA Program proof-of-concept was assessed as a single-arm, within-subjects
      clinical study with a target enrollment of 10 participants with possible or probable amnestic
      MCI. The protocol required participants to complete a pre-intervention assessment within two
      weeks of beginning the intervention, attend seven, one-hour intervention group sessions
      across six weeks, complete a post-assessment and interview in the final week of the
      intervention, and complete weekly surveys throughout the intervention. Participants were
      mailed materials, including the participant workbook and food, macronutrient, and ketone
      logs. Participants were also sent two bottles of ketone urine test strips for daily testing
      and materials to complete follow-up assessments. Throughout the program, participants were
      instructed to titrate into full ketosis across the first four weeks of the program by
      gradually reducing total carbohydrate intake and increasing healthy fat intake (e.g., fish,
      nuts, avocado, olive oils etc.). Thus, participants were not expected to attain measurable
      ketone levels until the final weeks of the program.
    

Intervention name(s): Motivational Interviewing-Cognitive Behavioral Therapy Ketogenic Nutrition Adherence Program
Intervention type(s): Behavioral
Intervention description(s): The intervention using strategies from motivational interviewing and cognitive behavioral therapy to promote motivation and adherence to ketogenic nutrition in older adults at high risk for Alzheimer's disease. The program is a 6-week, group program led by a psychologist and nutrition expert.
Other intervention name(s): MI-CBT KNA Program
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention