An interventional study of Diabetes Medical Nutrition Therapy (DM MNT) Pilot in Type 2 Diabetes, sponsored by Kaiser Permanente. Recruiting at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-09.
Sponsored by Kaiser Permanente · Not applicable, Interventional, and Health services research
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.
**Study Overview:** This is a two-arm pilot randomized implementation trial evaluating the delivery of Diabetes Medical Nutrition Therapy (DM MNT) for adults with type 2 diabetes and poor glycemic control (A1c ≥8%). Approximately 600 participants will be randomly assigned in a 1:1 ratio to either the DM MNT intervention or standard care. The study will evaluate both the implementation of MNT within routine diabetes care and its effectiveness in improving glycemic control and other clinical outcomes. Implementation outcomes will be assessed using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework.
**Setting:** The study will be conducted within Kaiser Permanente Southern California (KPSC), an integrated health system serving more than 4 million members across Southern California through a network of medical centers and outpatient clinics. The study will focus on the KPSC San Bernardino Regional Area, which has a relatively high prevalence of poorly controlled type 2 diabetes. The intervention is being evaluated as part of routine diabetes care to assess the feasibility and potential impact of integrating MNT into health-system clinical practice.
**Participants:** The study will enroll approximately 600 adults with type 2 diabetes who meet eligibility criteria, including poor glycemic control. Approximately 300 participants will be allocated to the DM MNT intervention and 300 to standard care. Randomization will occur in a 1:1 ratio using an automated allocation procedure based on a computer-generated sequence.
**Recruitment and Enrollment:** Potentially eligible patients will be identified through electronic health record queries based on prespecified inclusion and exclusion criteria. Eligible patients will be identified on a monthly basis and randomized to the intervention or standard care group. Patients assigned to the intervention group will be contacted by a licensed vocational nurse (LVN) from the Diabetes Department (Complete Care), as part of routine clinical outreach. The LVN will introduce the DM MNT program, assess patient interest, and facilitate enrollment. Additional outreach may be conducted by email when patients cannot be reached by telephone.
A waiver of individual research consent was obtained because the intervention is low risk and delivered within routine clinical care; yet participants receive an informational sheet with a detailed description of the study aims, procedures, participants' rights, among other details. Study data will be obtained from the electronic health record and program records and will be handled in accordance with applicable privacy and data protection requirements.
**Intervention:** The DM MNT Pilot is a clinical program designed to improve glycemic control and support diabetes self-management among adults with poorly controlled type 2 diabetes. Participants assigned to the intervention will receive individualized Medical Nutrition Therapy from Registered Dietitians (RDs) over 12 months. MNT will focus on six individualized nutrition assessment and counseling, dietary and lifestyle behavior change, goal setting, and ongoing support for diabetes self-management.. RDs will provide personalized recommendations based on participants' clinical characteristics, nutritional needs, preferences, and goals, and will coordinate care with the patient's clinical team as appropriate.
**Control:** Participants assigned to the control group will receive standard diabetes care available within KPSC and will not receive the DM MNT intervention through the study.
**Study Outcomes:** The study will evaluate implementation outcomes across the RE-AIM domains, including the reach of the intervention, effectiveness, adoption, implementation, and potential maintenance within routine health-system care. Clinical outcomes will include changes in glycemic control, with hemoglobin A1c as the primary clinical outcome. Additional clinical and health-care utilization outcomes will also be evaluated.
**Study Purpose:** Findings from this pilot study will provide information on the implementation and effectiveness of integrating MNT into routine diabetes care and will inform decisions about potential broader implementation of the program within KPSC.
9,589 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,332 are open to participants now.
This study's planned enrollment of 600 is above the median of 81 across 7,713 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Kaiser Permanente is the lead sponsor of 392 studies on the registry; 42 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 3 (43%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Mean Change From Baseline in Hemoglobin A1c (HbA1c)
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 (%)
Time frame: Baseline to 12 months.
Percentage of Participants With Hemoglobin A1c (HbA1c) ≤8% at Follow-Up
Percentage of participants with an HbA1c value ≤8% at 12 months (the end of the 6-session MNT intervention) compared to baseline. Unit of Measure: Percentage of participants (%)
Time frame: Baseline to 12 months.
Mean Change From Baseline in Body Weight
Mean change in body weight from baseline to 12 months (the end of the 6-session MNT intervention). Body weight will be obtained from the electronic health record and reported in kilograms. Change will be calculated as body weight at follow-up minus body weight at baseline. Unit of Measure: kg
Time frame: Baseline to 12 months.
Mean Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C)
Mean change in LDL-C from baseline to 12 months (the end of the 6-session MNT intervention). LDL-C will be obtained from the electronic health record and reported in mg/dL. Change will be calculated as LDL-C at follow-up minus LDL-C at baseline. Unit of Measure: mg/dL
Time frame: Baseline to 12 months.
Mean Change From Baseline in Body Mass Index (BMI)
Mean change in body mass index (BMI) from baseline to 12 months (the end of the 6-session MNT intervention). BMI will be calculated using height and body weight measurements recorded in the electronic health record and reported in kilograms per square meter (kg/m²). BMI will be calculated as weight in kilograms divided by height in meters squared. Change in BMI will be calculated as BMI at 12 months minus BMI at baseline. Unit of Measure: kg/m²
Time frame: Baseline to 12 months.
Reach of the Diabetes Medical Nutrition Therapy (MNT) Intervention
Reach of the diabetes MNT intervention will be assessed by the proportion of eligible patients who are referred to MNT and the proportion of referred patients who initiate MNT. Reach will also be assessed by comparing the demographic and clinical characteristics of patients who initiate MNT with those of the eligible patient population. Unit of Measure: Percentage of eligible patients and percentage of referred patients,
Time frame: From study initiation through completion of recruitment, up to 24 months.
Plan to share: Undecided — Data sharing will be considered in accordance with institutional policies, participant privacy and confidentiality requirements, and applicable data use and governance requirements.
Started Jun 2026 (actual). Primary completion is estimated for Dec 2027, 18 months after the start.
Of 1,924 non-industry interventional studies with no phase under Diabetes Mellitus, Type 2, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 39. This study's planned 18 months is below that.
Counting every sponsor, half of 2,101 studies reached it within 20 months; a quarter within 10 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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