MI-CBT Adherence Program for Lifestyle Interventions in Older Adults
Condition: Mild Cognitive Impairment; Adherence, Patient; Ketosis
MeSH terms: Cognitive Dysfunction
Study type: Interventional
Phase: Early Phase 1

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.
    

Detailed description: 
      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.

      Post-intervention EHR data download and Provider Assessment (Time 3). Approximately six
      months post-intervention, we will complete a final data extraction from the EHR, which will
      include the same data as Time 0. Additionally, we will complete semi-structured interviews
      with the clinic providers to assess implementation barriers and facilitators. Providers will
      also complete quantitative measures on implementation acceptability (i.e., Modified version
      of the Assessment of Fit Scale for outpatient clinics).

      Post-intervention Assessment (Time 4). Patient participants will complete this assessment
      approximately 3 months after completing the intervention program, in order to assess
      long-term maintenance. The research team will complete qualitative interviews with
      participants to collect information about barriers and facilitators to adhering to KN
      long-term. Participants will complete the RBANS Update - form C, the GDS, and FSQ. This
      assessment will be completed using HIPAA Compliant Zoom.

      Intervention Description:

      Using a centralized telehealth approach, the KNA program will consist of 6 weekly group
      meetings, which will take place via HIPAA-compliant Zoom. The group will be co-led by a
      clinical psychologist and a licensed nutritionist. Approximately half of each session will be
      devoted to providing nutrition information and half devoted to psychoeducation, MI
      activities, and CBT skills. Each group session will be recorded and rated by a trained
      clinician using a modified MI Coach Rating Scale to measure fidelity to MI-CBT strategies and
      reviewed with a recognized expert on MI and CBT. These recordings will be stored on a secure
      College of Medicine network drive and will only be used for the duration of the project and
      reviewed by the study team for quality control and intervention consistency. Any information
      from these recordings used for research purposes will be fully de-identified, with
      qualitative information transcribed and coded by the research team.

      MI-CBT KNA Week 1:

      The first group meeting will consist of a 1.5 hour informational and psychoeducational
      session to introduce participants to the purpose of the group, the ketogenic nutrition goals,
      and to the MI-CBT model of behavior change in relation to nutrition. Participants will be
      mailed a workbook that includes weekly goals, handouts on how to maintain KN, including daily
      recipes and food lists, as well as MI-CBT handouts and worksheets. Participants will be asked
      to slowly begin reducing daily net carbohydrate intake to 125g over the first week.

      The study team will provide individualized recommendations for macronutrient intake based on
      the net carbohydrate weekly goal and participant health information (e.g., sex, weight,
      height, activity level). Participants will log macronutrient intake in their food logs in
      order to ensure that approximately 60% of their diet involves healthy fats (e.g., fish,
      avocado, olive oils), and to begin learning the general macronutrient content of foods they
      consume. Participants will have the option of completing these food longs online or using
      paper copies at home. The focus of these first meetings will be on nutritional education and
      helping participants identify relevant values, goals, and reasons for committing to make
      healthy changes.

      MI-CBT KNA Weeks 2-4:

      In 1-hour weekly meetings, participants will learn about the CBT model and relevant skills,
      with assigned homework. Based on feedback from the feasibility trial, the program will
      emphasize cognitive restructuring and problem-solving as primary skills, while handouts on
      additional techniques (e.g., distress tolerance, behavioral activation, mindfulness) will be
      provided as optional.

      These skills will help participants identify health goals, manage triggers for unhealthy
      eating behaviors, and overcome external obstacles to healthy eating. MI will be employed
      throughout these sessions, through worksheets as well as reflective listening, summarizing,
      affirming, and open-ended questions from the group leaders. Participants will be instructed
      to gradually reduce their net carbohydrate intake across the first 3 weeks of the program in
      a step-wise fashion (i.e., 125g in week 1, 75g in week 2, 50g or less in week 3) in order to
      reduce possible adverse responses to the diet (e.g., GI distress, fatigue). Healthy fat
      intake is a core component of this program, and participants will be provided with ample
      instruction on ways to increase healthy fat intake while maintaining a healthy balance of
      macronutrients (e.g., 60% fat, 30% protein, 10% carbohydrates).

      MI-CBT KNA Weeks 5-6:

      In the final two sessions, the focus will shift to emphasize CBT skills practice, maintenance
      of goals, sustainment of progress, and social support. Participants will make maintenance
      plans, learn to manage slips, and continue practicing cognitive restructuring skills. The
      recommended net carbohydrate intake will be reduced to 20g or less these weeks, depending on
      individual ketone level and macronutrients.

      KN-Only (Condition 2):

      Participants assigned to the KN-only group will attend a 1.5-hour informational session as a
      group, which will provide comprehensive information about how to adhere to KN and how to
      track macronutrients, food intake, and ketone levels. Participants will be provided with the
      same participant workbook as the MI-CBT KNA group with informational handouts and KN recipes,
      but without the MI-CBT handouts. Participants will be asked to track food intake and daily
      ketone levels, and will be provided with the option of attending a weekly Zoom meeting where
      they may ask questions about KN and receive additional nutrition information as needed. These
      optional meetings will be offered for 6 weeks. The structure of this control condition will
      allow us to examine of the benefits that an MI-CBT group approach provides for increasing
      adherence to KN and retention in a KN program, compared to KN education only.

      MODIFICATION: EHR data collection and recruitment through the Senior Health clinic were
      determined to not be feasible based on the available patient data. The protocol was updated
      prior to the intervention to include collection of health and biomarker data during in-person
      assessments in place of EHR data collection. Recruitment was extended to all eligible
      community and independent living older adults and was not restricted to patients at the
      senior health clinic.
    

Intervention name(s): Motivational Interviewing-Cognitive Behavioral Therapy Ketogenic Nutrition Adherence Program; Ketogenic Nutrition Program
Intervention type(s): Behavioral; Other
Intervention description(s): Experimental Arm: The program is a 6-week group, telehealth intervention for older adults with possible MCI. The intervention uses Motivational interviewing and cognitive behavioral therapy strategies to enhance motivation and help participants overcome personal obstacles to following health-behavior recommendations. Specifically, the program examines the use of a Mediterranean ketogenic type of nutrition to target mild cognitive impairment. The intervention is designed to disseminate practical information to help older adults learn how to incorporate healthy Mediterranean ketogenic nutrition into their lifestyle.; Active Comparator Arm: 6-week group, telehealth intervention for older adults. The intervention is designed to disseminate practical information to help older adults learn how to incorporate healthy Mediterranean ketogenic nutrition into their lifestyle.
Other intervention name(s): KN Information-Only
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention