A Subsidized Healthy Food Prescription Program for Adults with type 2 Diabetes who are Experiencing Food Insecurity: Protocol for a Randomized Controlled Trial, Modelling and Implementation Studies

Abstract Background: The high cost of many healthy foods poses a significant challenge to the maintenance of optimal blood glucose levels for adults with type 2 diabetes (T2DM) who are experiencing food insecurity, leading to diabetes complications and excess acute care usage and costs. Subsidized healthy food prescription programs may help to reduce food insecurity by financially supporting patients to improve their diet quality, prevent diabetes complications and avoid acute care use. This study will use a type 2 hybrid effectiveness-implementation design to examine the reach, effectiveness, adoption, implementation and maintenance (RE-AIM) of a subsidized healthy food prescription program for adults who are experiencing food insecurity and persistent hyperglycemia. A randomized controlled trial (RCT) will investigate program effectiveness via impact on blood glucose levels (primary outcome), food insecurity, diet quality and other clinical and patient-reported outcomes. A modelling study will estimate longer-term program effectiveness in reducing diabetes-related complications, resource use and costs. An implementation study will examine all RE-AIM domains, including reasons behind program successes and failures, fidelity, mechanisms of impact, contextual determinants of effective implementation and sustainability. Methods: 404 adults who are experiencing food insecurity and persistent hyperglycemia, including adults who identify as Indigenous, will be randomized to a subsidized healthy food prescription intervention (n=202) or a healthy food prescription comparison group (n=202). Both groups will receive a healthy food prescription. The intervention group will additionally receive $1.50/day/household member to purchase healthy foods in supermarkets for 6 months. The implementation process will follow the Quality Implementation Framework. Outcomes will be assessed at baseline and follow-up (6 months) in the RCT and analyzed using mixed-effects linear and multinomial logistic/ordinal regression models. Longer-term outcomes will be modelled using the validated UK Prospective Diabetes Study outcomes simulation model-2. Implementation processes and outcomes will be continuously measured via quantitative and qualitative data and analyzed using descriptive statistics and theory-informed directed content analysis, respectively. Discussion: This research will provide a comprehensive body of data with high internal and external validity to assist policymakers and practitioners to effectively and rapidly translate the evidence generated into programs and policies to support patients with T2DM who are experiencing food insecurity. Trial registration: ClinicalTrials.gov NCT04725630 (January 25, 2021; https://www.clinicaltrials.gov/ct2/show/NCT04725630?term=Subsidized+Healthy+Food+Prescription+Program&cond=Diabetes+Mellitus%2C+Type+2&draw=2&rank=1).

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A Subsidized Healthy Food Prescription Program for Adults With Type 2 Diabetes Who Are Experiencing Food Insecurity: Protocol for a Randomized Controlled Trial

Current Developments in Nutrition ◽

10.1093/cdn/nzab057_002 ◽

2021 ◽

Vol 5 (Supplement_2) ◽

pp. 1272-1272

Author(s):

Sharlette Dunn ◽

Dana Olstad ◽

Reed F Beall ◽

Eldon Spackman ◽

Lorraine Lipscombe ◽

...

Keyword(s):

Blood Glucose ◽

Food Insecurity ◽

Diet Quality ◽

Diabetes Complications ◽

Controlled Trial ◽

Healthy Food ◽

Healthy Foods ◽

Glucose Levels ◽

Blood Glucose Levels ◽

Average Blood Glucose

Abstract Objectives It is vital for individuals with type 2 diabetes (T2DM) to adhere to a healthy dietary pattern to maintain optimal blood glucose levels and overall health. Increasing costs of healthy foods, however, are a barrier to maintaining healthful dietary patterns, particularly for individuals with T2DM who are experiencing food insecurity. Poor diet quality may result in difficulties maintaining optimal blood glucose levels, leading to higher rates of diabetes complications, and increased acute care usage and costs. Although the adverse impacts of food insecurity on maintaining optimal blood glucose levels are well documented, effective strategies to this among individuals with T2DM are lacking. One approach is providing subsidies to purchase healthy foods through subsidized healthy food prescription programs. These programs may help reduce food insecurity and improve diet quality, thereby improving blood glucose levels and reducing diabetes complications over time. Methods A parallel group randomized controlled trial will examine the effectiveness of a subsidized healthy food prescription program compared to a healthy food prescription alone in improving average blood glucose levels (primary outcome), and other secondary outcomes among 404 adults who are experiencing food insecurity and persistent hyperglycemia. The subsidized healthy food prescription program consists of two core elements: 1) A one-time healthy food prescription pamphlet that outlines an evidence-based healthy dietary pattern; 2) A healthy food subsidy of $1.50/day/household member to purchase healthy foods in participating supermarkets for 6 months. At baseline and 6-month follow-up, participants will provide responses to sociodemographic and health-related items, and a variety of patient-reported outcomes. Biochemical and physical measurements will also be obtained. Results The study's theory of change posits that reducing food insecurity and improving diet quality will be key mediators in improving blood glucose levels, which may reduce diabetes complications, and healthcare usage and costs over time. Conclusions The results of this study will demonstrate if a subsidized healthy food prescription program results in meaningful changes in average blood glucose levels and other clinically relevant outcomes. Funding Sources Alberta Innovates, Alberta Health Services.

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A randomized controlled trial evaluating the effects of tai chi training on indicators of glycaemic control and insulin resistance in adults with raised blood glucose levels

Journal of Science and Medicine in Sport ◽

10.1016/j.jsams.2009.10.441 ◽

2010 ◽

Vol 12 ◽

pp. e210-e211

Author(s):

L. Xin ◽

N. Burton ◽

W. Brown

Keyword(s):

Insulin Resistance ◽

Randomized Controlled Trial ◽

Blood Glucose ◽

Glycaemic Control ◽

Tai Chi ◽

Controlled Trial ◽

Glucose Levels ◽

Randomized Controlled ◽

Blood Glucose Levels

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Mobile-based insulin dose adjustment for type 2 diabetes in community and rural populations: study protocol for a pilot randomized controlled trial

Therapeutic Advances in Endocrinology and Metabolism ◽

10.1177/2042018819836647 ◽

2019 ◽

Vol 10 ◽

pp. 204201881983664 ◽

Cited By ~ 2

Author(s):

Anish Menon ◽

Leonard Gray ◽

Farhad Fatehi ◽

Dominique Bird ◽

Darsy Darssan ◽

...

Keyword(s):

Blood Glucose ◽

Dose Adjustment ◽

Controlled Trial ◽

Insulin Dose ◽

Community Outreach ◽

Routine Care ◽

Glucose Levels ◽

Blood Glucose Levels ◽

Pilot Randomized Controlled Trial

Background: Insulin initiation and/or titration for type 2 diabetes (T2DM) is often delayed as it is a resource-intensive process, often requiring frequent exchange of information between a patient and their diabetes healthcare professional, such as a credentialed diabetes educator (CDE) for insulin dose adjustment (IDA). Existing models of IDA are unlikely to meet the increasing service demand unless efficiencies are increased. Mobile health (mHealth), a subset of Ehealth, has been shown to improve glycaemic control through enhanced self-management and feedback leading to improved patient satisfaction and could simultaneously reduce costs. Considering the potential benefits of mHealth, we have developed an innovative mHealth-based care model to support patients and clinicians in diabetes specialist community outreach and telehealth clinics, that is, REthinking Model of Outpatient Diabetes care utilizing EheaLth – Insulin Dose Adjustment (REMODEL-IDA). This model primarily aims to improve the glycaemic management of patients with T2DM on insulin, with the secondary aims of improving healthcare service delivery efficiency and the patients’ experience. Methods/Design: A two-arm pilot randomized controlled trial (RCT) will be conducted for 3 months with 44 participants, randomized at a 1:1 ratio to receive either the mHealth-based model of care (intervention) or routine care (control), in diabetes specialist community outreach and telehealth clinics. The intervention arm will exchange information related to blood glucose levels via the Mobile Diabetes Management System developed for outpatients with T2DM. They will receive advice on insulin titration from the CDE via the mobile-app and receive automated text-message prompts for better self-management based on their blood glucose levels and frequency of blood glucose testing. The routine care arm will be followed up via telephone calls by the CDE as per usual practice. The primary outcome is change in glycated haemoglobin, a marker of glycaemic management, at 3 months. Patient and healthcare provider satisfaction, and time required to perform IDA by healthcare providers in both arms will be collected. This pilot study will guide the conduct of a large-scale pragmatic RCT in regional Australia.

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A randomized, controlled trial of oral versus intravenous fluids for lowering blood glucose in emergency department patients with hyperglycemia

CJEM ◽

10.2310/8000.2013.131082 ◽

2014 ◽

Vol 16 (03) ◽

pp. 214-219 ◽

Cited By ~ 3

Author(s):

Sanjay Arora ◽

Marc A. Probst ◽

Laura Andrews ◽

Marissa Camilion ◽

Andrew Grock ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Blood Glucose ◽

Adverse Events ◽

Controlled Trial ◽

Fluid Administration ◽

Intravenous Fluids ◽

Glucose Levels ◽

Randomized Controlled ◽

Blood Glucose Levels ◽

The Mean

ABSTRACT Objectives: Blood glucose can be lowered via insulin and/or fluid administration. Insulin, although efficacious, can cause hypoglycemia and hypokalemia. Fluids do not cause hypoglycemia or hypokalemia, but the most effective route of fluid administration has not been well described. This study compared the efficacy and safety of oral versus intravenous fluids for reducing blood glucose in patients with hyperglycemia. Methods: We conducted a prospective, nonblinded, randomized, controlled trial. Inclusion criteria were blood glucose > 13.9 mmol/L, age > 18 years, and ability to tolerate oral fluids. Subjects were excluded for critical illness, contraindication to fluids, and/or hyperglycemia therapy prior to enrolment. Subjects were randomized to receive oral bottled water or intravenous normal saline (maximum 2 L) over 2 hours. The primary outcome of interest was a change in blood glucose at 2 hours across treatment arms. Results: The 48 subjects were randomized. Baseline blood glucose levels and total amount of fluid received were similar between the two groups. The mean decrease in blood glucose at 2 hours was similar for both treatment arms: a mean decrease of 3.4 mmol/L (20.2 mmol/L to 16.8 mmol/L) in the oral fluid group versus a mean decrease of 4.0 mmol/L (19.7 mmol/L to 15.7 mmol/L) in the intravenous fluid group. The mean difference between groups was −0.6 mmol/L (95% confidence interval −2.3–1.2; p = 0.51). No adverse events were observed in either group. Conclusion: In this unblinded randomized trial, oral and intravenous fluids were equally efficacious in lowering blood glucose levels in stable hyperglycemic patients and no adverse events were noted. Physicians should be mindful that, although similar, the reduction in blood glucose was modest in both groups.

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Effects of Feedback From Self-Monitoring Devices on Lifestyle Changes in Prediabetes Workers: A 3-Month Randomized Controlled Trial (Preprint)

10.2196/preprints.23261 ◽

2020 ◽

Author(s):

Tomohisa Nagata ◽

Sona-Sanae Aoyagi ◽

Minekazu Takahashi ◽

Masako Nagata ◽

Koji Mori

Keyword(s):

Blood Glucose ◽

Health Behaviors ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Self Monitoring ◽

Glucose Levels ◽

Randomized Controlled ◽

Blood Glucose Levels ◽

Daily Exercise

BACKGROUND Although lifestyle interventions are useful in prevention and management of diabetes, they can be expensive and time-consuming. There is some evidence for the effectiveness of automated mobile technology for health self-monitoring, however, no studies have used such devices with prediabetes workers. OBJECTIVE We aimed to examine the effectiveness of a 3-month digital self-monitoring device on glucose levels and health behaviors of prediabetes workers in Japan. The primary outcome was blood glucose levels and the secondary outcomes were changes in health behaviors and BMI. METHODS A two-arm randomized controlled trial was conducted with workers from 23 organizations. The intervention group (n=50, data analyzed for n=46) wore an armband activity monitor, a body composition monitor, and a blood pressure monitor for 3 months and received semi-automated weekly email messages tailored to their device data. The control group (n=53, data analyzed for n=48) engaged in no self-monitoring. Messages were developed by a physician and a dietician. Post-intervention changes in blood glucose levels, BMI, and health behaviors were compared between the intervention and control groups using blood tests and device data. RESULTS At the end of 3 months, the intervention group showed significantly lower blood glucose levels (HbA1c [%]: intervention mean 6.4 vs. control mean 6.6; Cohen d=0.7; 95% CI 0.2-1.1; P=.009) and significantly greater motivation to increase their daily exercise than the control group. There were no significant between-group differences in BMI or health behaviors. CONCLUSIONS Mobile digital self-monitoring was effective in improving blood glucose levels and motivation to increase daily exercise in prediabetes workers. The use of digital health devices is a cost-effective way of implementing health self-monitoring for large numbers of individuals in the workplace. CLINICALTRIAL This study is registered with the University Hospital Medical Information Network (UMIN000023651).

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