Healthy Eating and Active Living to Reverse Diabetes Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Tennessee
- Enrollment
- 35
- Locations
- 2
- Primary Endpoint
- Change in Hemoglobin A1c (HbA1c)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Change in Hemoglobin A1c (HbA1c)
Time Frame: Baseline to 6 months
Change in HbA1c (%) from baseline to 6 months
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
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
- Change in Random Blood Glucose(Baseline to 6 months)
- Change in Diabetes Self-Efficacy Score(Baseline to 6 months)
- Change in Diabetes Self-Care Activities Score(Baseline to 6 months)
- Cost of Intervention Delivery(6 months)
Investigators
James E. Bailey, MD, MPH
Executive Director, Tennessee Population Health Consortium
University of Tennessee