Pilot Trial of an Motivational Interviewing-Cognitive Behavioral Therapy Ketogenic Nutrition Adherence Program for Older Adults

Preparation. During the first 6 months of the study, the investigators will work closely with key stakeholders (i.e., clinic director, practice manager, and nurse practitioner) in the Florida State University (FSU) SeniorHealth clinic to coordinate initial contact with patients about the study. Initial contact will include posting flyers in the SeniorHealth clinic, handing out flyers during appointments, and emailing flyers or calling patients who have consented to be contacted about FSU research studies (a consent process, which is completed as part of the normal SeniorHealth intake packet), posting flyers in the Westminster Oaks monthly newsletter, and patients will be able to fill out a contact card with their name, phone number, and email that will be placed in a locked "drop box" in the SeniorHealth clinic. A study team member will collect these cards weekly to enter into a secure screening waitlist. Patients may also discuss interest with their provider or contact the study team directly using the information on the study flyer, potential participants will be added to a secure screening waitlist, which will include only their name and phone number. This screening waitlist potential participant contact information will be stored in a password protected document. Contact information for potential participants will be destroyed for any participant who does not qualify and consent to remain in the study.

Screening phone call. After confirming interest in being contacted about the study, participants will be contacted by a member of the research team and screened for eligibility. This screening will include a telephone Montreal cognitive assessment (MoCA), sections 1 and 4 from the Functional Status Questionnaire (FSQ), a brief memory complaint scale, and self-reported height, weight, and age. Participants will also be asked to report any restrictive dietary or medical conditions that may make them unable to change their nutrition. This contact information will not be retained for future research purposes. All screened participants will be provided with a handout on healthy living designed in collaboration with the SeniorHealth physicians. If participants are eligible, then they will be sent an online consent form, which they will read and review telephonically with a member of the research team before signing. The study team will then complete a final eligibility check of the patient's EHR and review with the physician to confirm eligibility and ensure participant safety. Participants who are eligible and consent to participate will have screening data linked with other study data, in order to reduce redundancy in assessment measures.

Pre-intervention EHR data download (Time 0). The research team will extract and clean relevant EHR data on participants who consent to participate in the study. Data from EHR will be used to conduct a secondary eligibility screening to determine if there are any other major health conditions that will exclude participants from the study. Data will only include the minimum protected health information (PHI) necessary to complete the proposed study. Data from the EHR will include the following information only from appointments pertinent to the study: patients' problem/diagnostic list, medication list, patient vitals, metabolic panels, HbA1C, scores on recent cognitive and psychological assessments (i.e., MoCA, depression inventories), and relevant provider notes about a patient's cognitive functioning. Participants that are seen by FSU clinicians will be considered for the study and contacted by our team. Their EHR is maintained on Athena and thus all the information will be accessed from Athena. Clinic staff working for FSU will be responsible for screening their EHR and determining their eligibility for the study. These data will include the participants MoCA scores, the geriatric depression inventory (GDS), and FSQ scores or relevant qualitative data about their activities of daily living, and demographic characteristics. The study team will also include laboratory results that may be relevant to cognitive outcomes for secondary data analyses, including: HbA1c, glucose, potassium, blood pressure, and cholesterol. All laboratory data will be pulled from the EHR, and will not require additional bloodwork or labs to be completed by patient participants.

Baseline Assessment (Time 1). In addition to embedded EHR data, we are collecting additional data to evaluate the personal impacts of the intervention. This assessment will include: the Repeatable Battery of Neuropsychological Status (RBANS update - form A), the GDS, FSQ, and CAIDE risk score. This assessment will be completed using HIPAA Compliant Zoom.

Post-intervention Assessment (Time 2). Participants will complete this assessment in the final weeks of the program, in order to assess participants when they are in ketosis. Participants will be asked to return their ketone logs either electronically, reported over the phone, or via mail to the study PI. The research team will complete qualitative interviews with participants to collect information about barriers and facilitators to completing the program and adhering to KN. Participants will complete the RBANS update - Form B, the GDS, and FSQ, and the client satisfaction questionnaire . This assessment will be completed using HIPAA Compliant Zoom.