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KPSC MNT Pilot RCT

KPSC Diabetes Medical Nutrition Therapy (MNT) Pilot Randomized Controlled Trial

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 75 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 12 months

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Participants assigned to the intervention will receive individualized Medical Nutrition Therapy from Registered Dietitians (RDs) over 12 months."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests a nutrition care program for adults with type 2 diabetes and high blood sugar. It will look at how well the program works, whether it improves blood sugar, and how it could become part of regular diabetes care.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are a Kaiser Permanente Southern California member.
  • You have type 2 diabetes.
  • You are 18–75 years old when the study's eligibility list is made.
  • Your latest A1c test in the past 6 months is 8%–13%. A1c measures your average blood sugar.
  • You have an upcoming visit with a care manager.

Who can't join

  • You had stage 4 or 5 kidney disease, meaning severe kidney disease, in the past 6 months.
  • You are receiving dialysis, a treatment that filters your blood, or had dialysis care in the past 6 months.
  • You have cancer and received chemotherapy, radiation, or immune-based cancer treatment in the past 6 months.
  • Your records show pregnancy in the past 9 months.
  • You were diagnosed with an eating disorder in the past 3 years.
  • You received hospice or palliative care in the past 6 months. These services focus on comfort and symptom relief.
  • You are receiving nutrition through a feeding tube or a vein, as shown in records from the past 6 months.

Simplified for readability. The official criteria below are what the study team uses.

Official 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)

Study sites (1)

CA