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IRB No. 19-206S-1: Just Us Moving Program in the State of Connecticut (JUMP-CT)

JUMP-CT aims to increase light physical activity and reduce weight in the African and Hispanic American populations with type 2 diabetes in the greater Hartford region. This program is a simple behavioral modification program focused on decreasing the hemoglobin A1c levels, a marker of blood sugar levels,in diabetics and in turn improving the management of diabetes and its associated complications and risk factors over time.

IRB No. 24-213-1 (Dr. Andrea Shields, PI): Development and Validation of a Non-Invasive Microbiome-Based Diagnostic Tool for Early Detection of Gestational Diabetes Mellitus

Gestational Diabetes Mellitus (GDM) is the development of glucose intolerance during pregnancy and is a serious complication with an incidence of 18% among pregnant people in the US. Recent evidence suggests that the gut microbiome undergoes changes parallel to GDM development early in pregnancy. This creates an important opportunity to establish a microbiome-based early screening tool to predict and potentially prevent GDM. Hypothesis/Question: Can a report containing risk scores for GDM based on proprietary stool collection from pregnant patients during their first trimester be developed to send to healthcare professionals promptly? Aims / objectives: We aim to develop a screening tool for the prediction of GDM as early as trimester 1 (T1) before the recommended administration of Oral Glucose Tolerance Test. Through non-invasive gut microbiome testing, we will determine T1 gut microbiome signatures associated with GDM and, based on these findings, develop an Machine Learning-based prediction model for GDM. This would allow for preventative treatment strategies before the disease becomes symptomatic and its side effects on the pregnant person and child become irreversible. The project aim is to demonstrate that the T1 maternal gut microbiome is a valid early indicator of GDM development, and an ML predictive model based on the microbiome';s characteristics permits accurate prediction of GDM development.

IRB No. 26-108-1 (Dr. Cato Laurencin, PI): Medically tailored meals in Connecticut: A pilot study to assess the feasibility health outcomes for adults with diabetes in underserved urban and rural communities.

Chronic diseases like Type 2 diabetes disproportionately affect low-income communities, where food insecurity and limited access to nutritious meals hinder disease management. In Connecticut, 10.7% of adults have diabetes, with higher prevalence among African American and Hispanic populations. Traditional dietary advice often fails without access to healthy food. Medically tailored meals (MTMs)—nutritionally customized, home-delivered meals designed by registered dietitians—have shown promise in improving glycemic control, reducing healthcare utilization, and enhancing patient satisfaction. Pilot programs in Bridgeport and Hartford have demonstrated positive outcomes, yet MTMs remain largely uncovered by Medicare and Medicaid, limiting reach. Community-based recruitment may improve engagement and adherence compared to clinical referrals. Study Rationale Despite growing evidence, MTM programs face barriers in recruitment and adherence. Most prior studies relied on clinical referrals, potentially excluding individuals without access or trust in healthcare settings. Community-based recruitment may offer better reach, cultural alignment, and satisfaction. This pilot study will compare recruitment pathways and gather preliminary data for future large-scale implementation. This study aims to evaluate attitudes, satisfaction, and health outcomes among underserved individuals with diabetes recruited via community vs. clinical pathways. Objectives and Aims Primary Objective To assess feasibility, reach, and effectiveness of community-based vs. clinic-based recruitment for enrolling food-insecure adults with Type 2 diabetes into a 12-week MTM program. Secondary Objectives Evaluate participant attitudes, satisfaction, and adherence to MTMs. Estimate MTM effects on weight, blood pressure, self-reported health, and healthcare utilization. Aims and Hypotheses Aim 1: Participant Attitudes and Satisfaction Compare acceptability, cultural suitability, intention to change, and satisfaction between recruitment arms. Hypothesis: Community-recruited participants will report higher satisfaction and more positive attitudes. Aim 2: Recruitment, Adherence, and Retention Compare eligibility yield, enrollment rates, time-to-enroll, adherence, and retention. Hypotheses: Community recruitment will yield equal or higher enrollment and faster time-to-enroll. Community participants will show higher retention and fewer barriers. ≥80% of community participants will adhere to meal ordering. Aim 3: Health Outcomes (Exploratory) Assess changes in PROMIS-29 domains and HbA1c. Hypothesis: Participants may show improvements in health outcomes. Study Design 12-week pilot study providing MTMs twice daily to 20 adults with Type 2 diabetes in underserved Connecticut communities. Participants will be recruited via community organizations (Arm A) or clinical referrals (Arm B). Data will be collected through surveys, chef logs, and biometric measures. Target Population Inclusion criteria: Adults 18-year-old age or older with: Type 2 diabetes mellitus Medicaid or Medicare Advantage plan HbA1c threshold > 5.7% in the past three months Able to speak English or Spanish language Resident of Connecticut Able to provide informed consent. Exclusion Criteria Type 1 diabetes Advanced diabetes (e.g., individuals with chronic diabetic complications) Severe cognitive (e.g., severe dementia or Alzheimer's disease) Physical impairments (e.g., individuals who have experienced a stroke within the past three months that affects their balance or ability to walk). Recent major cardiovascular events (e.g., including heart attack, stroke, transient ischemic attacks, revascularization procedures, or those currently participating in a cardiac rehabilitation program.) Individuals with a history of arrhythmia will be excluded unless they have a pacemaker or are currently taking medication to manage the condition A history of pulmonary embolism within the past six months or a recent diagnosis of congestive heart failure will also preclude participation. Uncontrolled hypertension (e.g., uncontrolled severe hypertension, defined as a blood pressure greater than 180/120) Pregnancy (e.g., current pregnancy, plans to become pregnant within the next three months, or becoming pregnant during the course of the study.) Alcohol misuse (AUDIT score ≥8) - (e.g., Individuals with problematic alcohol use, as indicated by an AUDIT score of 8 or higher, will be excluded due to the potential interference of heavy alcohol consumption with HbA1c testing) Individuals with chronic obstructive pulmonary disease (COPD) who require continuous oxygen therapy. Patients with end-stage liver disease Recruitment Strategy Phase I: Prescreening Flyers distributed at community sites and clinics Recruitment Response Form is completed Prescreening includes questionnaires: The Validated 2-item Hunger sign (HVS) screening from The ACLM Diet Screener -9-Lifestyle medicine questionnaire The Alcohol use disorders identification test (AUDIT) _Screening-Tool Phase II: Insurance Referral Eligible participants will contact their health plan to see if they are eligible to receive a home-delivered meals benefit from MOM'S MEALS, or they will contact their Area Agency on Aging at - North Central Area Agency on Aging, 151 New Park Ave, Box 75, Hartford, CT 06106,Phone: (860) 724-6443 - to see if they qualify for government-funded programs. Vendor -Mom's Meal -assesses allergies/comorbidities and confirms financial eligibility. Phase III: Enrollment Eligible participants contacted for in-person consent and baseline visit Baseline includes biometrics, HbA1c, and surveys administration Data Collection Instruments The Validated 2-item Hunger sign (HVS) screening form The ACLM Diet Screener -9-Lifestyle medicine questionnaire The Alcohol use disorders identification test (AUDIT) _Screening-Tool ACLM Diet Screener 9_lifestyle medicine questionnaire DSat-28 diet satisfaction questionnaire POMP - Home Delivered Meals Survey PROMIS-29 v2.1 questionnaire Social Support _ Eating Habits Survey Social Support _Exercise questionnaire Data Collection Timeline Week Activities 0 (Baseline) Consent, biometrics, HbA1c, surveys 4 Follow-up surveys, adherence check 8 Follow-up surveys, adherence check 12 Final surveys, biometrics, HbA1c Evaluation Tools CONSORT-style flow diagram: Recruitment efficiency Weekly referral logs: Retention tracking Vendor delivery logs: Adherence measurement Focus groups: Qualitative feedback on MTM experience