NCT07868250 · Kaiser Permanente
KPSC MNT Pilot RCT
(DM MNT Pilot)
What this study is about
The purpose of this pilot randomly assigned trial is to evaluate the implementation and effectiveness of a Diabetes Medical Nutrition Therapy (DM MNT) program for adults with type 2 diabetes and poor glycemic control receiving care in a large integrated health system.
View original scientific description
The purpose of this pilot randomized trial is to evaluate the implementation and effectiveness of a Diabetes Medical Nutrition Therapy (DM MNT) program for adults with type 2 diabetes and poor glycemic control receiving care in a large integrated health system. The study will assess implementation outcomes using the RE-AIM framework, as well as changes in glycemic control and other clinical outcomes, to inform potential broader implementation of MNT within routine diabetes care.
Interventions
BEHAVIORAL
Diabetes Medical Nutrition Therapy (DM MNT) Pilot
DM MNT intervention is a targeted clinical initiative designed to improve glycemic control and overall health outcomes for adults with poorly controlled diabetes (HgbA1c ≥ 8%) in San Bernardino County. The program leverages evidence based Medical Nutrition Therapy (MNT) provided by Registered Dietitians (RDs) as a primary intervention, emphasizing personalized care, behavior change support, and coordinated management with clinical teams.
Primary outcome measures
Mean Change From Baseline in Hemoglobin A1c (HbA1c)
Time frame: Baseline to 12 months.
Mean change in HbA1c from baseline to from baseline to 12 months (the end of the 6-session MNT intervention). HbA1c will be obtained from the electronic health record and reported as a percentage (%). Change will be calculated as HbA1c at follow-up minus HbA1c at baseline. Unit of Measure: Percentage points (%)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Kaiser Permanente Southern California member
- Type 2 diabetes diagnosis (ICD-10 codes E11. (all subcodes for type 2 diabetes))
- Ages 18-75 (Age calculated as of the date the eligibility list is generated. Include patients whose age is ≥18 and ≤75 on that date)
- Glycated hemoglobin (A1c) between 8-13 (Most recent hemoglobin A1c value within the past 6 months is ≥8% and ≤13% as of the date the eligibility list is generated)
- Actively seeing a care manager (Have an upcoming appointment with a Care Manager)
Exclusion criteria
- Kidney disease stage 4-5 (ICD-10 codes: N18.4 (CKD stage 4), N18.5 (CKD stage 5) within last 6 months)
- Current dialysis (Procedure codes: CPT 90935, 90937, 90945, 90947, 90999; OR encounter with dialysis service in last 6 months)
- Active cancer treatment (ICD-10 codes for cancer (C00-C97) combined with recent treatment (chemotherapy, radiation, immunotherapy) within last 6 months)
- Pregnancy (ICD-10 codes O00-O9A, positive pregnancy test labs, or encounters with OB/GYN codes indicating pregnancy in last 9 months)
- Diagnosed eating disorders (ICD-10 codes: F50.\
- (all eating disorder subcodes). within past 36 months)
- Currently in palliative care/hospice (Encounter type or service codes for hospice or palliative care in the past 6 months)
- Currently receiving Nutrition Support (Orders for enteral or parenteral nutrition (EN/PN) or dietitian notes indicating ongoing nutrition support in the past 6 months: ID codes: 670795, 520142, 525183, 534927)
Where
- Fontana, California
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 9, 2026 · Source of record for eligibility and locations