NCT07027995 - Food and Fitness With Medicine (FFWM) | Crick | Crick

NCT07027995 - Food and Fitness With Medicine (FFWM) | Crick | Crick

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosis of at least one of the following conditions: hypertension, type 2 diabetes, hyperlipidemia, chronic kidney disease, and/or metabolic syndrome. * At least 18 years of age at the time of signing consent. * Participants must have reliable transportation to attend Exercise is Medicine sessions. * Access to an internet-enabled device. * No objections to online grocery shopping, home food deliveries, or nutrition counseling. * Residence meets Instacart delivery requirements (e.g., non-institutionalized). * Participant is willing to use a personal credit card for Instacart back-up payments. * Participants must speak English to be able to consent and engage in FIM and EIM programs. * Participant has been clinically prescribed GLP-1RA's. Exclusion Criteria: * Conditions that impact digestion, metabolism, or food intake (e.g. surgical loss of esophagus, stomach, or colon, pancreatic dysfunction, bariatric surgery, brain surgery that alters cognition, etc.). * Participants with uncontrolled mental illness disorders (e.g., schizophrenia, bipolar disorder, major depression, etc.) that are not well-managed or controlled through treatment, as determined by the study team. * Familial history of certain cancers (e.g., multiple endocrine neoplasia, medullary thyroid carcinoma, etc.). * Active digestive illnesses (i.e., Celiac disease, irritable bowel syndrome, chronic malabsorption). * Comorbidities such as psychiatric or general illness that may put the subject at risk as determined by the investigator/s. * Renal impairment, eGFR \< 60 ml/min/1.73m2 * Factor which, in the investigator's opinion, is likely to compromise the subject's ability to participate in the study. * Recent participation (e.g., 3 months) in other behavioral nutrition trials or programs (i.e., bariatric programs, diabetes education programs). * Currently pregnant or planning to become pregnant during the study. * Participant is not willing to provide a urine, blood, or stool sample.

Outcomes

Primary Outcomes

GLP-1 RA discontinuation rates

GLP-1RA discontinuation rates will be captured using the electronic medical record to obtain medication name and formulation, dosage and frequency, prescription start and end dates, prescribing provider, refill information and prescription status (active, discontinued, completed), clinic notes or medication reconciliation fields confirming ongoing use or discontinuation, pharmacy records indicating medication pick-up (when available).

Time frame: 0, 12, and 24 weeks

Secondary Outcomes

American Heart Association (AHA) PREVENT Scores

The AHA PREVENT scores are used in cardiovascular research to estimate the risk of future cardiovascular disease (CVD) based on factors such as BMI, age, sex, cholesterol, blood pressure, smoking, eGFR, diabetes, medication use, UACR, zip, and HbA1c. Scores are reported as a percent risk for CVD using the following scale: low (\<5%), borderline (5% to 7.4%), intermediate (7.5% to 19.9%), and high (\>20%).

Time frame: 0, 12, and 24 weeks

Metabolites

Stool and urine samples will be collected from participants to analyze metabolites at 3 study time points. Participants will collect samples and return within 7 days of a clinic visit. Samples will be processed and stored under strict biosafety protocols to maintain integrity.

Time frame: 0, 12, and 24 weeks

Life's Essential 8 Scores

The Life's Essential 8 Survey is a combination of questions used to assess and needed to accurately collect data to determine Life's essential 8 (LE8 scores for participants). Questions collect data on lifestyle health behaviors such as sleep patterns and smoking status. The Life's Essential 8 (LE8) is scored on a scale of 0 to 100. The LE8 score is used to assess and track an individual's overall cardiovascular health based on 8 key factors with a higher score indicating better cardiovascular health.

Time frame: 0, 12, and 24 weeks

Blood Lipids

Trained phlebotomists will perform a venous blood draw. The total amount of blood that will be collected for lipids (total cholesterol, high density lipoprotein (HDL), low density lipoprotein (LDL)) for this entire research study (3 time points over 24 weeks) is less than 2.5 mL (\<1 teaspoon).

Time frame: 0, 12, and 24 weeks

Body Composition

We will look at body composition to monitor shifts in muscle mass, body fat, and visceral fat throughout the intervention. Participants will be weighed, wearing light clothing and without shoes, on a calibrated bioelectrical impedance scale (seca mBCA Ultra) capable of analyzing body composition including visceral fat, total body fat percentage, lean body mass, and resting energy expenditure.

Time frame: 0, 12, and 24 weeks

Dietary Patterns

The National Cancer Institute's Dietary History Questionnaire (DHQIII) will be used to assess dietary patterns. The DHQIII tool is validated and assesses dietary intake of 134 foods and beverages in the past 30 days using the Healthy Eating Index score. Scores range 0-100 with higher scores indicating better overall diet quality.

Time frame: 0, 12, and 24 weeks

Hip Circumference

Hip circumference will be measured with a measuring tape following the current NHANES Anthropometry Procedures Manual.

Time frame: 0, 12, and 24 weeks

Dermal Carotenoid Scores

Resonance Raman spectroscopy (RRS) is a non-invasive, validated method of measuring dermal carotenoids as a biomarker of fruit and vegetable intake. The Pharmanex NuSkin Biophotonic Scanner (model S3) uses a standardized RSS protocol intended for nutritional purposes and will not be used to diagnose any disease or medical condition. The scan involves passing a safe LED light across the surface of the skin for approximately 2 minutes. 2-3 measures will be obtained at each time point.

Time frame: 0, 12, and 24 weeks

Blood Pressure

Blood pressure including both systolic and diastolic blood pressure measures will be checked via an automated oscillometric sphygmomanometer (Omron 7 series).

Time frame: 0, 12, and 24 weeks

Nutrition Security

The Center for Nutrition and Health Impact Nutrition Security Screener will be used to assess nutrition security. The Center for Nutrition and Health Impact developed a four-item nutrition security screening tool. Three questions ask about household consumption and concerns around foods thought by the respondent to be good (or not) for health and well-being, and a fourth question asks about food variety.

Time frame: 0, 12, 24 weeks.

Social and Emotional Wellbeing

The De Jon Gierveld Social Isolation Scale will be used to asses social and emotional wellbeing. This short form, 6-item scale can be used as a reliable and valid measurement instrument for overall, emotional, and social loneliness. For this scale each item is assigned a score of 0 or 1 with the total possible score ranging form 0 to 6 with high scores indicating higher rates of loneliness.

Time frame: 0, 12, and 24 weeks

Social Needs

Centers for Medicare and Medicaid Services Accountable Health Communities Health-Related Social Needs Screening Tool will be used to identify needs. Tested by the CMS Innovation, this tool addresses the critical gap between clinical care and community services in the current health care delivery system by testing whether systematically identifying and addressing the health-related social needs of Medicare and Medicaid beneficiaries impacts their total health care costs and improves health. The questionnaire includes 26 questions addressing living situation, food security, transportation, utilities, safety, financial strain, employment, family and community support, education, physical activity, substance abuse, mental health and disabilities. This screening tool is not scored on a standardized scale rather participants screening positive for unmet social needs will be referred to available and free community resources (e.g., Health Impact Ohio, SNAP, MidOhio Food Farmacy, etc).

Time frame: 0, 12, and 24 weeks

HbA1c

Trained phlebotomists will perform a venous blood draw. The total amount of blood that will be collected for HbA1c for this entire research study (3 time points over 24 weeks) is less than 2.5 mL (\<1 teaspoon).

Time frame: 0, 12, and 24 weeks

Waist Circumference

Waist circumference will be measured with a measuring tape following the current NHANES Anthropometry Procedures Manual.

Time frame: 0, 12, and 24 weeks

Food Noise

The Food Noise Questionnaire (FNQ) is a 5-item instrument to assess the frequency and intensity of intrusive food-related thoughts, urges, and preoccupations. Each item is scored 0-5, with a total score range of 0-20. Higher scores indicate greater perceived food noise.

Time frame: 0, 12, 24 and weeks