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RECRUITING Not applicable ClinicalTrials.gov

KPSC MNT Pilot RCT

Sponsor: Kaiser Permanente • ClinicalTrials.gov ID: NCT07868250

Registry updated: 2026-10-09
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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

  • Diabetes Medical Nutrition Therapy (DM MNT) Pilot (Behavioral)
    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.

Eligibility criteria

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)

Conditions

Type 2 Diabetes

Locations

  • Kaiser Permanente San Bernardino County Medical Center — Fontana, California, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record