[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659818":3},{"organization":4,"outcomesModule":7,"designInfo":31,"detailedDescription":39,"studyPopulation":36,"armGroups":40,"interventions":49,"overallOfficials":36,"centralContacts":55,"locations":61,"responsibleParty":87,"collaborators":36,"id":89,"slug":90,"hasResults":91,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":95,"eligibilityCriteria":96,"healthyVolunteers":91,"sex":97,"minAge":98,"maxAge":99,"enrollmentInfo":100,"targetDuration":36,"studyType":103,"phases":104,"briefSummary":106,"conditions":107,"keywords":109,"overallStatus":64,"whyStopped":36,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":127},{"fullName":5,"class":6},"Kaiser Permanente","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":26},[9],{"measure":10,"description":11,"timeFrame":12},"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.\n\nUnit of Measure:\n\nPercentage points (%)","Baseline to 12 months.",[14,17,20,23],{"measure":15,"description":16,"timeFrame":12},"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.\n\nUnit of Measure: Percentage of participants (%)",{"measure":18,"description":19,"timeFrame":12},"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.\n\nUnit of Measure: kg",{"measure":21,"description":22,"timeFrame":12},"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\u002FdL. Change will be calculated as LDL-C at follow-up minus LDL-C at baseline.\n\nUnit of Measure: mg\u002FdL",{"measure":24,"description":25,"timeFrame":12},"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\u002Fm²). 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\u002Fm²",[27],{"measure":28,"description":29,"timeFrame":30},"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,","From study initiation through completion of recruitment, up to 24 months.",{"allocation":32,"interventionModel":33,"interventionModelDescription":34,"primaryPurpose":35,"observationalModel":36,"timePerspective":36,"maskingInfo":37},"RANDOMIZED","PARALLEL","This is a two-arm pilot randomized implementation trial. Participants will be randomly assigned (1:1) to the intervention or control group (standard care).","HEALTH_SERVICES_RESEARCH",null,{"masking":38,"maskingDescription":36,"whoMasked":36},"NONE","\\*\\*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.\n\n\\*\\*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.\n\n\\*\\*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.\n\n\\*\\*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.\n\nA 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.\n\n\\*\\*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.\n\n\\*\\*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.\n\n\\*\\*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.\n\n\\*\\*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.",[41,46],{"label":42,"type":43,"description":36,"interventionNames":44},"Intervention: Diabetes Medical Nutrition Therapy (DM MNT) Pilot","EXPERIMENTAL",[45],"Behavioral: Diabetes Medical Nutrition Therapy (DM MNT) Pilot",{"label":47,"type":48,"description":36,"interventionNames":36},"Control: Standard Care","NO_INTERVENTION",[50],{"type":51,"name":52,"description":53,"armGroupLabels":54,"otherNames":36},"BEHAVIORAL","Diabetes Medical Nutrition Therapy (DM MNT) Pilot","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.",[42],[56],{"name":57,"role":58,"phone":59,"phoneExt":36,"email":60},"Taynara Formagini, PhD","CONTACT","626-564-3427","Taynara.X.Formagini@kp.org",[62],{"facility":63,"status":64,"city":65,"state":66,"zip":67,"country":68,"countryCode":69,"cosmosGeoPoint":70,"geoPoint":75,"contacts":76},"Kaiser Permanente San Bernardino County Medical Center","RECRUITING","Fontana","California","92335","United States","US",{"type":71,"coordinates":72},"Point",[73,74],-117.43505,34.09223,{"lat":74,"lon":73},[77,81,84],{"name":78,"role":58,"phone":79,"phoneExt":36,"email":80},"Valerie T Steve, MPH","855-266-4560","Valerie.T.Steve@kp.org",{"name":82,"role":58,"phone":79,"phoneExt":36,"email":83},"Angela Shumaker, MPH, RDN","Angela.O.Shumaker@kp.org",{"name":85,"role":86,"phone":36,"phoneExt":36,"email":36},"Taynara Formagini, PhD, MSc","PRINCIPAL_INVESTIGATOR",{"type":88,"investigatorFullName":36,"investigatorTitle":36,"investigatorAffiliation":36,"oldNameTitle":36,"oldOrganization":36},"SPONSOR","100659818","kpsc-mnt-pilot-rct-100659818",false,"NCT07868250","KPSC MNT Pilot RCT","KPSC Diabetes Medical Nutrition Therapy (MNT) Pilot Randomized Controlled Trial","DM MNT Pilot","Inclusion Criteria:\n\n* Kaiser Permanente Southern California member\n* Type 2 diabetes diagnosis (ICD-10 codes E11. (all subcodes for type 2 diabetes))\n* 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)\n* 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)\n* Actively seeing a care manager (Have an upcoming appointment with a Care Manager)\n\nExclusion Criteria:\n\n* Kidney disease stage 4-5 (ICD-10 codes: N18.4 (CKD stage 4), N18.5 (CKD stage 5) within last 6 months)\n* Current dialysis (Procedure codes: CPT 90935, 90937, 90945, 90947, 90999; OR encounter with dialysis service in last 6 months)\n* Active cancer treatment (ICD-10 codes for cancer (C00-C97) combined with recent treatment (chemotherapy, radiation, immunotherapy) within last 6 months)\n* Pregnancy (ICD-10 codes O00-O9A, positive pregnancy test labs, or encounters with OB\u002FGYN codes indicating pregnancy in last 9 months)\n* Diagnosed eating disorders (ICD-10 codes: F50.\\* (all eating disorder subcodes). within past 36 months)\n* Currently in palliative care\u002Fhospice (Encounter type or service codes for hospice or palliative care in the past 6 months)\n* Currently receiving Nutrition Support (Orders for enteral or parenteral nutrition (EN\u002FPN) or dietitian notes indicating ongoing nutrition support in the past 6 months: ID codes: 670795, 520142, 525183, 534927)","ALL","18 Years","75 Years",{"count":101,"type":102},600,"ESTIMATED","INTERVENTIONAL",[105],"NA","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.",[108],"Type 2 Diabetes",[110,111,112,113,114,115,116,117],"nutrition therapy","medical nutrition therapy","diabetes mellitus, type 2","type 2 diabetes","diabetes management","diabetes control intervention","glycemic control","glycemic control intervention","2026-10-05",{"date":120,"type":121},"2026-10-09","ACTUAL",{"date":123,"type":121},"2026-06-17",{"date":125,"type":102},"2028-07",{"name":5,"class":6},1]