An interventional study of Intensive Multicomponent Healthy Eating and Weight Loss Intervention and Enhanced Usual Diabetes Care in Diabete Type 2, Diabetes and Overweight , Obesity, sponsored by University of Tennessee. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-05.
Sponsored by University of Tennessee · Not applicable, Interventional, and Treatment
The HEAL Diabetes Program is a multicomponent intensive plant-forward healthy eating program designed to reverse diabetes. Several recent studies, most notably the Diabetes UK-funded Diabetes Remission Clinical Trial (DiRECT) in England and Scotland, have demonstrated that intensive programs for weight loss and weight loss maintenance can lead to long-term remission of diabetes for as many as half of patients with early Type 2 (adult-onset) diabetes. Furthermore, the U.S. Preventive Services Task Force has recommended that all patients with obesity and at highest risk for diabetes be referred to such intensive multicomponent behavioral weight loss interventions, but no such programs are available for people living in the low-income and underserved areas of Memphis. This effort will pilot an innovative, culturally tailored, and intensive healthy eating program designed to reverse diabetes based in the UTHSC Neighborhood Health Hub located in low-income neighborhoods to demonstrate that this approach will work in Memphis to improve and extend people's lives. The HEAL Diabetes Pilot Program will: a) engage and retain a minimum of 30 patients with Type 2 diabetes and obesity to participate in the program as well as 30 additional "control" patients who will receive routine care, and b) assess patient outcomes including weight loss and rates of diabetes remission using average blood sugar (hemoglobin A1c) over a six-month period. The healthy eating and active living to reverse diabetes (HEAL Diabetes) is a pilot study that aims to evaluate the feasibility, effectiveness, and operational and financial sustainability of a multicomponent health coach-supported nutrition intervention in a predominately African American population in Memphis, Tennessee. The investigators aim to assess study feasibility by evaluating recruitment, sample characteristics, intervention acceptability and procedural suitability. The investigators also aim to quantify and compare the treatment and control groups on primary outcomes including changes in body weight, hemoglobin A1c (HbA1c), and proportion of patients who achieved diabetes remission (HbA1c25 \< 6.5%) from baseline to 12-months. Additionally, the investigators aim to assess changes in diabetes self-efficacy and self-care activities and examine cost effectiveness of the multicomponent intervention. Drawing on evidence from DiRECT, MODEL, and related studies, the investigators hypothesize that the intervention arm will achieve greater weight loss and higher diabetes remission than the control. Additionally, the investigators hypothesize that the program will be operationally and financially sustainable.
9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.
This study's enrollment of 35 is below the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →University of Tennessee is the lead sponsor of 139 studies on the registry; 21 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 2 (29%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria: Patients must meet the following criteria to be eligible:
Exclusion Criteria:
Participants in this arm received enhanced usual care only. Enhanced usual care consisted of standard diabetes education, health coaching, and routine clinical management provided by their existing healthcare providers. No additional study-delivered classes, coaching, or materials were provided. Participants completed study assessments on the same schedule as the intervention group.
Behavioral: Enhanced Usual Diabetes Care
Participants in this arm received a structured, multicomponent diabetes remission intervention promoting healthy eating and intensive weight loss in addition to usual care. The intervention included biweekly group sessions over the study period, covering nutrition and weight management; cooking classes; individual health coaching; 3-month diet replacement; and physician-supervised medication discontinuation. The program also included goal-setting, progress check-ins, and supportive accountability delivered by health coaches. Participants completed the same study assessments as the enhanced care arm.
Behavioral: Intensive Multicomponent Healthy Eating and Weight Loss Intervention
An intensive multicomponent diet and weight-loss intervention designed to support diabetes remission. The program included biweekly group sessions focused on low-carbohydrate, moderate-fat nutrition strategies; portion and calorie guidance; behavior-change skills; goal-setting; and weight-tracking. Participants also completed biweekly individual health-coaching sessions that provided personalized dietary guidance, problem-solving support, and adherence monitoring. The intervention incorporated 12 weeks of weekly total diet replacement provided through home delivery of lower-carbohydrate, lean-protein food items to facilitate adherence to dietary goals. During the total diet replacement phase participants also received physician-supervised medication discontinuation. Physical activity recommendations and strategies for managing blood glucose were also covered. The intervention was delivered by health coaches and provided in addition to participants' usual clinical care.
Participants received enhanced usual diabetes care. This included optional diabetes self-management education provided through routine clinic services, individualized health-coaching sessions provided at neighborhood health hub facilities focused on general diabetes management support. In addition, participants received four produce vouchers valued at $50 each to promote access to fresh fruits and vegetables. No additional study-delivered classes, dietary programming, or supplemental food items were provided.
Change in Body Weight
Change in body weight in pounds from baseline to 6 months
Time frame: From enrollment to the end of 6 months.
Change in Hemoglobin A1c (HbA1c)
Change in HbA1c (%) from baseline to 6 months
Time frame: Baseline to 6 months
Proportion of Participants Achieving Diabetes Remission
Proportion of participants achieving diabetes remission at 6 months, defined as HbA1c \< 6.5% without use of glucose-lowering medications for at least 2 months
Time frame: 6 months
Change in Random Blood Glucose
Change in random (non-fasting) blood glucose concentration from baseline to 6 months, measured using standard capillary or venous blood glucose testing in Milligrams per deciliter (mg/dL).
Time frame: Baseline to 6 months
Change in Diabetes Self-Efficacy Score
Change in diabetes self-efficacy from baseline to 6 months, assessed using the Stanford Diabetes Self-Efficacy Scale (DSES).
Time frame: Baseline to 6 months
Change in Diabetes Self-Care Activities Score
Change in diabetes self-care behaviors from baseline to 6 months, assessed using the Summary of Diabetes Self-Care Activities (SDSCA).
Time frame: Baseline to 6 months
Cost of Intervention Delivery
Total cost of delivering the intervention over 6 months, including personnel, materials, and program implementation expenses, estimated to inform potential scalability of the intervention.
Time frame: 6 months
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — Individual participant data (IPD) will not be shared because the dataset contains sensitive, identifiable health information, and sharing could compromise participant privacy. Data are intended for use only by the study team for the purposes outlined in the study protocol.
This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Tennessee