The Healthy Eating and Active Living to Reverse Diabetes Pilot Study (HEAL Diabetes)

Healthy Eating and Active Living to Reverse Diabetes Pilot Study

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.

Study Overview

• Status: Completed
• Conditions: Diabetes; Diabete Type 2; Overweight , Obesity
• Intervention / Treatment: Behavioral: Enhanced Usual Diabetes Care; Behavioral: Intensive Multicomponent Healthy Eating and Weight Loss Intervention

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Memphis, Tennessee, United States, 38105
      • UTHSC Health Hub-Uptown
    • Memphis, Tennessee, United States, 38109
      • UTHSC Health Hub-ShelbyCares

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria: Patients must meet the following criteria to be eligible:

• adults 18 years or older
• a type 2 diabetes (T2D) duration of 0-6 years (diagnosis based on one recorded HbA1c test)
• HbA1c value ≥ 6.5 percent at the screening visit
• BMI ≥ 25 kg/m2
• access to a cell phone or smartphone with texting and voicemail capabilities

Exclusion Criteria:

• current use of insulin or more than two hypoglycemic medications (either oral or injectable)
• a recent routine HbA1c greater than or equal to 12%
• weight loss of >5 kg within the last six months
• inability to understand consent procedures, understand and speak English
• pregnancy or considering pregnancy
• diagnosis or exhibited unstable psychiatric condition, dementia, neurological disorder, or history of severe head trauma or brain tumor, and cognitive impairment
• perceived unwillingness or inability to participate
• planned move from the region during the study
• participation in another clinical research trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Enhanced Care; 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 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.
Experimental: Intensive Care (Multicomponent Intervention); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Body Weight	Change in body weight in pounds from baseline to 6 months	From enrollment to the end of 6 months.
Change in Hemoglobin A1c (HbA1c)	Change in HbA1c (%) from baseline to 6 months	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	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).	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).	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.	6 months

Collaborators and Investigators

• Sponsor: University of Tennessee

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2023
• Primary Completion (Actual): August 2, 2025
• Study Completion (Actual): August 2, 2025

Study Registration Dates

• First Submitted: December 2, 2025
• First Submitted That Met QC Criteria: December 18, 2025
• First Posted (Actual): January 5, 2026

Study Record Updates

• Last Update Posted (Actual): January 5, 2026
• Last Update Submitted That Met QC Criteria: December 18, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: weight loss; diet; lifestyle; healthy eating; pragmatic; health coaching; behavioral change; multicomponent; community-based diabetes care
• Additional Relevant MeSH Terms: Endocrine System Diseases; Nutrition Disorders; Metabolic Diseases; Overnutrition; Body Weight; Body Weight Changes; Glucose Metabolism Disorders; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity; Weight Loss; Diabetes Mellitus, Type 2; Diabetes Mellitus
• Other Study ID Numbers: 23-09351-FB UM; A23-0844-001 (Other Identifier: UTHSC Office of Sponsored Programs)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No