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NCT Number: NCT07316569

The 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.

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Key information

Conditions

Diabete Type 2 Body Weight Body Weight Changes Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Overweight , Obesity Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UTHSC Health Hub-ShelbyCares, Memphis, Tennessee, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intensive Multicomponent Healthy Eating and Weight Loss Intervention

Behavioral

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.

Enhanced Usual Diabetes Care

Behavioral

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.

Primary outcomes

  1. Change in Body Weight

    Time frame: From enrollment to the end of 6 months.

    Change in body weight in pounds from baseline to 6 months

  2. Change in Hemoglobin A1c (HbA1c)

    Time frame: Baseline to 6 months

    Change in HbA1c (%) from baseline to 6 months

  3. Proportion of Participants Achieving Diabetes Remission

    Time frame: 6 months

    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

Secondary outcomes

  1. Change in Random Blood Glucose

    Time frame: Baseline to 6 months

    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).

  2. Change in Diabetes Self-Efficacy Score

    Time frame: Baseline to 6 months

    Change in diabetes self-efficacy from baseline to 6 months, assessed using the Stanford Diabetes Self-Efficacy Scale (DSES).

  3. Change in Diabetes Self-Care Activities Score

    Time frame: Baseline to 6 months

    Change in diabetes self-care behaviors from baseline to 6 months, assessed using the Summary of Diabetes Self-Care Activities (SDSCA).

  4. Cost of Intervention Delivery

    Time frame: 6 months

    Total cost of delivering the intervention over 6 months, including personnel, materials, and program implementation expenses, estimated to inform potential scalability of the intervention.

Sponsors and collaborators

Lead sponsor

University of Tennessee

Other

Registry information

Official study title

Healthy Eating and Active Living to Reverse Diabetes Pilot Study

Acronym: HEAL Diabetes

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jan 5, 2026
Registry last updated
Jan 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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