The Healthy Eating and Active Living to Reverse Diabetes Pilot Study

NCT ID: NCT07316569

Last Updated: 2026-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-11
• Study Completion Date: 2025-08-02

Brief Summary

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.

Conditions

Diabete Type 2; Diabetes; Overweight , Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Enhanced Usual Diabetes Care

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Intensive Multicomponent Healthy Eating and Weight Loss Intervention

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Tennessee

OTHER

Sponsor Role: lead

Responsible Party

James E. Bailey, MD, MPH

Executive Director, Tennessee Population Health Consortium

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

UTHSC Health Hub-Uptown

Memphis, Tennessee, United States

UTHSC Health Hub-ShelbyCares

Memphis, Tennessee, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

A23-0844-001

Identifier Type: OTHER

Identifier Source: secondary_id

23-09351-FB UM

Identifier Type: -

Identifier Source: org_study_id