Type 2 DiabetesDM MNT PilotNCT07868250
KPSC MNT Pilot RCT
A study testing Diabetes Medical Nutrition Therapy (DM MNT) Pilot in people with Type 2 Diabetes, run by Kaiser Permanente at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Diabetes Medical Nutrition Therapy (DM MNT) Pilot
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jun 2026to Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Kaiser Permanente San Bernardino County Medical Center
Fontana, California, 92335
Valerie T Steve, MPH, 855-266-4560, Valerie.T.Steve@kp.org
Angela Shumaker, MPH, RDN, 855-266-4560, Angela.O.Shumaker@kp.org
About this study
Official title: KPSC Diabetes Medical Nutrition Therapy (MNT) Pilot Randomized Controlled 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.
Read the detailed description
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.
- Conditions
- Type 2 Diabetes
- Being tested
- Diabetes Medical Nutrition Therapy (DM MNT) Pilot
- Keywords
- nutrition therapy, medical nutrition therapy, diabetes mellitus, type 2, type 2 diabetes, diabetes management, diabetes control intervention, glycemic control, glycemic control intervention
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diabetes Medical Nutrition Therapy (DM MNT) PilotBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention: Diabetes Medical Nutrition Therapy (DM MNT) Pilot | Experimental | Not described Receives: Behavioral: Diabetes Medical Nutrition Therapy (DM MNT) Pilot |
| Control: Standard Care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 (%)
Measured: Baseline to 12 months.
Secondary outcomes (4)
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 (%)
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline to 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study start17 Jun 2026
- Primary completionDec 2027 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a two-arm pilot randomized implementation trial. Participants will be randomly assigned (1:1) to the intervention or control group (standard care).
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07868250
- Sponsor's protocol ID
- 14548
- Acronym
- DM MNT Pilot
- Status last verified
- Sep 2026
- First submitted
- 21 Sep 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data sharing will be considered in accordance with institutional policies, participant privacy and confidentiality requirements, and applicable data use and governance requirements.
Publications
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.
PubMed 18165339Sikand 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.
PubMed 37165278Casagrande 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.
PubMed 36288809Orr 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.
PubMed 31151439Evert 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.
PubMed 31000505Molle 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.
PubMed 41078978Braunstein 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.
PubMed 33339763Moloney 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.
PubMed 41083126Hess-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.
PubMed 39847170Razaz 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.
PubMed 31186171Franz 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.
PubMed 28533169Boocock 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.
PubMed 33761151Garber 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.
PubMed 26731084Powers 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.
PubMed 26048904Ahola AJ, Groop PH. Barriers to self-management of diabetes. Diabet Med. 2013 Apr;30(4):413-20. doi: 10.1111/dme.12105.
PubMed 23278342
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- KPSC Diabetes Medical Nutrition Therapy (MNT) Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07868250
- Acronym / sponsor ID
- DM MNT Pilot / 14548
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Study start
- 17 Jun 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 9 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a two-arm pilot randomized implementation trial. Participants will be randomly assigned (1:1) to the intervention or control group (standard care).
| Arm | Type | Receives |
|---|---|---|
| Intervention: Diabetes Medical Nutrition Therapy (DM MNT) Pilot | Experimental | Behavioral: Diabetes Medical Nutrition Therapy (DM MNT) Pilot |
| Control: Standard Care | No intervention | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diabetes Medical Nutrition Therapy (DM MNT) PilotDM 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. | Behavioural | Intervention: Diabetes Medical Nutrition Therapy (DM MNT) Pilot |
Primary outcome
Mean Change From Baseline in Hemoglobin A1c (HbA1c)
Time frame: Baseline to 12 months.
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 (%)
4 secondary outcomes
Percentage of Participants With Hemoglobin A1c (HbA1c) ≤8% at Follow-Up
Time frame: Baseline to 12 months.
Mean Change From Baseline in Body Weight
Time frame: Baseline to 12 months.
Mean Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C)
Time frame: Baseline to 12 months.
Mean Change From Baseline in Body Mass Index (BMI)
Time frame: Baseline to 12 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Background: PubMed 18165339American 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.
- Background: PubMed 37165278Sikand 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.
- Background: PubMed 36288809Casagrande 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.
- Background: PubMed 31151439Orr 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.
- Background: PubMed 31000505Evert 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.
- Background: PubMed 41078978Molle 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.
- Background: PubMed 33339763Braunstein 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.
- Background: PubMed 41083126Moloney 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.
- Background: PubMed 39847170Hess-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.
- Background: PubMed 31186171Razaz 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.
- Background: PubMed 28533169Franz 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.
- Background: PubMed 33761151Boocock 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.
- Individual participant dataSharing planned: Undecided. Data sharing will be considered in accordance with institutional policies, participant privacy and confidentiality requirements, and applicable data use and governance requirements.
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Metabolic and Inflammatory Outcomes of the Ketogenic Diet Comparing Saturated and Unsaturated Fat Sources
PreDiabetes, Diabetes Mellitus, Type 2
Not yet recruitingPhase 1/2
A Study Testing the Safety and Possible Benefits of an Ear Injection of a New Compound, Paliroden, in People With Type 2 Diabetes Who Have Difficulty Understanding Speech in Noisy Situations
Cochlear Synaptopathy
Not yet recruitingPhase 1
A Research Study to Check the Safety of NNC9836-0001 When Given to Healthy Participants and Participants With Type 2 Diabetes
Diabetes Mellitus, Type 2
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diabetes Medical Nutrition Therapy (DM MNT) Pilot in people with Type 2 Diabetes, run by Kaiser Permanente at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Taynara Formagini, PhD (626-564-3427, Taynara.X.Formagini@kp.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change From Baseline in Hemoglobin A1c (HbA1c) (time frame: Baseline to 12 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07868250, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.