KPSC MNT Pilot RCT
ConditionType 2 Diabetes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorKaiser Permanente
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Diabetes Medical Nutrition Therapy (DM MNT) Pilot
BehavioralDM 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.
Treatment groups
600 Participants
are divided into 2 treatment groupsGroup A: Intervention: Diabetes Medical Nutrition Therapy (DM MNT) PilotExperimental treatment 1 intervention
Group B: Control: Standard CareNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.Secondary outcomes
1
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.2
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.3
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.4
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.Other outcomes
1
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov