KPSC MNT Pilot RCT

NCT07868250 | Recruiting

• 1 other identifier: 14548
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 2 Diabetes

Keywords

nutrition therapy; medical nutrition therapy; diabetes mellitus, type 2; type 2 diabetes; diabetes management; diabetes control intervention; glycemic control; glycemic control intervention

Outcome Measures

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 (%)

  Baseline to 12 months.

Secondary Outcomes (4)

• Percentage of Participants With Hemoglobin A1c (HbA1c) ≤8% at Follow-Up

  Baseline to 12 months.

• Mean Change From Baseline in Body Weight

  Baseline to 12 months.

• Mean Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C)

  Baseline to 12 months.

• Mean Change From Baseline in Body Mass Index (BMI)

  Baseline to 12 months.

Other Outcomes (1)

• Reach of the Diabetes Medical Nutrition Therapy (MNT) Intervention

  From study initiation through completion of recruitment, up to 24 months.

Study Arms (2)

Intervention: Diabetes Medical Nutrition Therapy (DM MNT) Pilot

EXPERIMENTAL

Behavioral: Diabetes Medical Nutrition Therapy (DM MNT) Pilot

Control: Standard Care

NO INTERVENTION

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.

Intervention: Diabetes Medical Nutrition Therapy (DM MNT) Pilot

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Kaiser Permanente: lead

Study Sites (1)

Kaiser Permanente San Bernardino County Medical Center

Fontana, California, 92335, United States

RECRUITING

Related Publications (16)

• American Diabetes Association; Bantle JP, Wylie-Rosett J, Albright AL, Apovian CM, Clark NG, Franz MJ, Hoogwerf BJ, Lichtenstein AH, Mayer-Davis E, Mooradian AD, Wheeler ML. Nutrition recommendations and interventions for diabetes: a position statement of the American Diabetes Association. Diabetes Care. 2008 Jan;31 Suppl 1:S61-78. doi: 10.2337/dc08-S061. No abstract available.

  PMID: 18165339 BACKGROUND

• Sikand G, Handu D, Rozga M, de Waal D, Wong ND. Medical Nutrition Therapy Provided by Dietitians is Effective and Saves Healthcare Costs in the Management of Adults with Dyslipidemia. Curr Atheroscler Rep. 2023 Jun;25(6):331-342. doi: 10.1007/s11883-023-01096-0. Epub 2023 May 11.

  PMID: 37165278 BACKGROUND

• Casagrande SS, Bullard KM, Siegel KR, Lawrence JM. Food insecurity, diet quality, and suboptimal diabetes management among US adults with diabetes. BMJ Open Diabetes Res Care. 2022 Oct;10(5):e003033. doi: 10.1136/bmjdrc-2022-003033.

  PMID: 36288809 BACKGROUND

• Orr CJ, Keyserling TC, Ammerman AS, Berkowitz SA. Diet quality trends among adults with diabetes by socioeconomic status in the U.S.: 1999-2014. BMC Endocr Disord. 2019 May 31;19(1):54. doi: 10.1186/s12902-019-0382-3.

  PMID: 31151439 BACKGROUND

• Evert AB, Dennison M, Gardner CD, Garvey WT, Lau KHK, MacLeod J, Mitri J, Pereira RF, Rawlings K, Robinson S, Saslow L, Uelmen S, Urbanski PB, Yancy WS Jr. Nutrition Therapy for Adults With Diabetes or Prediabetes: A Consensus Report. Diabetes Care. 2019 May;42(5):731-754. doi: 10.2337/dci19-0014. Epub 2019 Apr 18. No abstract available.

  PMID: 31000505 BACKGROUND

• Molle J, Agnel J, Colson S, Chays-Amania A. Using implementation science to promote evidence-based nutritional care in healthcare settings: A mixed-methods systematic review. Int J Nurs Stud Adv. 2025 Aug 24;9:100414. doi: 10.1016/j.ijnsa.2025.100414. eCollection 2025 Dec.

  PMID: 41078978 BACKGROUND

• Braunstein N, Guerrero M, Liles S, Germann A, Kuppich M, Martin H, Schofield M, Yoder Latortue K. Medical Nutrition Therapy for Adults in Health Resources & Services Administration-Funded Health Centers: A Call to Action. J Acad Nutr Diet. 2021 Oct;121(10):2101-2107. doi: 10.1016/j.jand.2020.10.023. Epub 2020 Dec 16.

  PMID: 33339763 BACKGROUND

• Moloney L, Rozga M, Steiber A, Handu D. The Effectiveness of Medical Nutrition Therapy in Prevention and Treatment of Chronic Disease: A Position Paper of the Academy of Nutrition and Dietetics. J Acad Nutr Diet. 2026 Feb;126(2):156219. doi: 10.1016/j.jand.2025.10.010. Epub 2025 Oct 11.

  PMID: 41083126 BACKGROUND

• Hess-Fischl A. The Value of Medical Nutrition Therapy and Diabetes Self-Management Education and Support in Diabetes Care and Education: A Call to Action to Increase Referrals and Recognize Insurance Coverage Variation. Curr Diab Rep. 2025 Jan 23;25(1):18. doi: 10.1007/s11892-024-01573-z.

  PMID: 39847170 BACKGROUND

• Razaz JM, Rahmani J, Varkaneh HK, Thompson J, Clark C, Abdulazeem HM. The health effects of medical nutrition therapy by dietitians in patients with diabetes: A systematic review and meta-analysis: Nutrition therapy and diabetes. Prim Care Diabetes. 2019 Oct;13(5):399-408. doi: 10.1016/j.pcd.2019.05.001. Epub 2019 Jun 9.

  PMID: 31186171 BACKGROUND

• Franz MJ, MacLeod J, Evert A, Brown C, Gradwell E, Handu D, Reppert A, Robinson M. Academy of Nutrition and Dietetics Nutrition Practice Guideline for Type 1 and Type 2 Diabetes in Adults: Systematic Review of Evidence for Medical Nutrition Therapy Effectiveness and Recommendations for Integration into the Nutrition Care Process. J Acad Nutr Diet. 2017 Oct;117(10):1659-1679. doi: 10.1016/j.jand.2017.03.022. Epub 2017 May 19. No abstract available.

  PMID: 28533169 BACKGROUND

• Boocock RC, Lake AA, Haste A, Moore HJ. Clinicians' perceived barriers and enablers to the dietary management of adults with type 2 diabetes in primary care: A systematic review. J Hum Nutr Diet. 2021 Dec;34(6):1042-1052. doi: 10.1111/jhn.12875. Epub 2021 Mar 24.

  PMID: 33761151 BACKGROUND

• Garber AJ, Abrahamson MJ, Barzilay JI, Blonde L, Bloomgarden ZT, Bush MA, Dagogo-Jack S, DeFronzo RA, Einhorn D, Fonseca VA, Garber JR, Garvey WT, Grunberger G, Handelsman Y, Henry RR, Hirsch IB, Jellinger PS, McGill JB, Mechanick JI, Rosenblit PD, Umpierrez GE; American Association of Clinical Endocrinologists (AACE); American College of Endocrinology (ACE). CONSENSUS STATEMENT BY THE AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS AND AMERICAN COLLEGE OF ENDOCRINOLOGY ON THE COMPREHENSIVE TYPE 2 DIABETES MANAGEMENT ALGORITHM--2016 EXECUTIVE SUMMARY. Endocr Pract. 2016 Jan;22(1):84-113. doi: 10.4158/EP151126.CS. No abstract available.

  PMID: 26731084 BACKGROUND

• Powers MA, Bardsley J, Cypress M, Duker P, Funnell MM, Hess Fischl A, Maryniuk MD, Siminerio L, Vivian E. Diabetes Self-management Education and Support in Type 2 Diabetes: A Joint Position Statement of the American Diabetes Association, the American Association of Diabetes Educators, and the Academy of Nutrition and Dietetics. Diabetes Care. 2015 Jul;38(7):1372-82. doi: 10.2337/dc15-0730. Epub 2015 Jun 5. No abstract available.

  PMID: 26048904 BACKGROUND

• Ahola AJ, Groop PH. Barriers to self-management of diabetes. Diabet Med. 2013 Apr;30(4):413-20. doi: 10.1111/dme.12105.

  PMID: 23278342 BACKGROUND

• Puzhakkal S, Kavanagh S, Conway B, Kow CS, Hasan SS. Self-care and self-management in diabetes: concepts, theories and practices. Int J Clin Pharm. 2025 Dec;47(6):2094-2100. doi: 10.1007/s11096-025-01941-z. Epub 2025 Jun 9.

  PMID: 40489012 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Early Growth Response Protein 3

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Early Growth Response Transcription Factors; DNA-Binding Proteins; Proteins; Amino Acids, Peptides, and Proteins; Immediate-Early Proteins; Transcription Factors

Central Study Contacts

Taynara Formagini, PhD

CONTACT

626-564-3427; Taynara.X.Formagini@kp.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a two-arm pilot randomized implementation trial. Participants will be randomly assigned (1:1) to the intervention or control group (standard care).

Study Record Dates

• First Submitted: September 21, 2026
• First Posted: October 9, 2026
• Study Start: June 17, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): July 1, 2028
• Last Updated: October 9, 2026

Record last verified: 2026-09

Locations

US (1)