Clinical trial NCT02426138: Community Servings: Food as Medicine for Diabetes
Official title: Community Servings: Food as Medicine for Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2015-04-24
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Food insecurity, defined as difficulty accessing food owing to cost, affects 1 in 5 diabetes patients. To address this, the investigators are conducting a pilot randomized controlled trial of medically tailored meal delivery (MTM). The pilot study has two specific aims:

Aim 1: To determine the effect of receiving MTM on dietary quality for food insecure diabetes patients with hyperglycemia Aim 2: To determine the feasibility and acceptability of the program as a medical intervention and refine the program as needed for testing in larger studies.

This study is a crossover randomized controlled pilot trial, where approximately 50 participants, 25 in each arm, will be randomized to receipt of 12 weeks of MTM, to begin immediately, or waitlist control. After 12 weeks, the groups will crossover, with the waitlist control group now receiving 12 weeks of MTM. At baseline, 12 weeks, and 24 weeks, the participants will complete assessments of their dietary quality (HEI score), psychosocial measures such as diabetes distress and food insecurity, along with measures of body mass index, blood pressure, hemoglobin A1c, and lipids.

Detailed description: a. Historical background The Center for Disease Control and Prevention (CDC) estimates that there are currently 29 million people with diabetes and 86 million people with pre-diabetes in the U.S. One in 10 Americans has diabetes now, and, if current trends continue, 1 in 3 Americans will have diabetes by 2050. This chronic disease significantly impacts both quality of life and rapidly rising national healthcare costs. The estimated cost of diabetes in the U.S. in 2014 was $265 billion with $176 billion in direct medical costs and $89 billion is indirect medical costs (disability, work loss, premature mortality). Medical expenses for people with diabetes are 2.3 times higher than for people without diabetes.

Food insecurity, defined as limited access to nutritious food due to cost, has been associated with increased prevalence of diabetes and worse diabetes control. Food insecurity may worsen diabetes by decreasing consumption of fresh fruits and vegetables and increasing consumption of inexpensive, calorie-dense food, and which in turn leads to greater Hemoglobin A1c, an indicator of hyperglycemia, over time.

c. Rationale behind the proposed research, and potential benefits to participants and/or society

Approximately 20% of diabetes patients report food insecurity, a number that increases to over 25% among those with the worst metabolic control.5 The prevalence of food insecurity is also 20% in the MGH Population we surveyed (data not yet published). Hyperglycemia is particularly responsive to dietary changes,8 yet few interventions have attempted to address food insecurity in diabetes care. Prior studies have examined the impact of the Supplemental Nutrition Assistance Program (SNAP, formerly the Food Stamp Program), but have not found important improvements in diabetes outcomes for participants9. This may be because neighborhood access to produce and other high quality food is low for many SNAP participants, or because making healthy food choices is difficult in resource-constrained environments. Additionally, recent sociological work has shown that expecting low-income women to cook healthy meals for their families induces a significant burden, and the burden of these expectations may drive less healthy food choices. Additionally, while significant time is needed for healthy food preparation, low-income patients often face limited leisure time, and multiple competing demands for both time and financial resources. Alternatively, direct provision of healthy foods was incidentally noted to improve diabetes outcomes in a prior randomized controlled trial, but this study was not conducted with the goal of addressing food insecurity.

In this study, we propose to test whether home delivery of freshly prepared meals specifically tailored to the needs of diabetes patients improves their dietary quality. We hypothesize that the delivery of the meals will help them eat more healthily and improve the food security of participants. Secondary outcomes in this pilot study will be weight and metabolic control, along with psychological aspects of diabetes care.

Aim 1: To evaluate the effectiveness of receiving Community Servings meals on dietary quality for food insecure diabetes patients with severe hyperglycemia (HbA1c \> 8.0%) H1. Primary outcome. Healthy Eating Index 2010 (HEI) score: We hypothesize that the CS group will demonstrate greater improvements in dietary quality, as assessed by HEI score, at 12 weeks, compared with usual care. The sample size of 50 provides 80% power to detect a 5 point difference between the CS and usual care groups, assuming an 11 point standard deviation and accounting for a 10% drop-out rate.

H1b. Secondary exploratory outcomes. Medical outcomes: We hypothesize that compared with usual care, CS group participants will improve HbA1c, blood pressure, weight, and lipids from baseline at the end of the intervention.

H1c. Behavioral and psychosocial outcomes: Because meal provision will reduce stress related to procuring healthy meals, and free up household resources that would otherwise be spent on food, we hypothesize that compared with usual care, the CS groups will have greater improvements from baseline in patient-reported outcomes of diabetes distress and material need security.

Aim 2: To evaluate the feasibility of providing meals and patient experience with the CS program, particularly focusing on factors that determine acceptability, continuation, and scalability We will use a mixed methods approach using participant structured interviews and surveys to assess engagement and satisfaction with the program, and participant interviews or focus groups to compare responders and non-responders. We will also collect quantitative indicators of feasibility and implementation such as percent of meals delivered and consumed, enrollment and persistence with the program, and logistical issues in order to plan for a future full-scale intervention.

Eligibility criteria: Inclusion Criteria:

* • Diagnosis of type 2 diabetes

  * Age 18 years or older
  * HbA1c level \>8.0%
  * Report food insecurity as indicated by the 2-item USDA Food Security Survey Module13
  * Willing to commit to random assignment to either receive CS meals immediately or as a waitlist control
  * Stable health, with no severe medical comorbidities that might interfere with their ability to participate in the intervention, such as severe psychiatric illness or imminent hospitalization
  * Be willing to keep a food diary
  * Be willing to attend and complete a baseline, 12 week, and 24 week assessment at MGH
  * Be able to understand and communicate effectively in English
  * Have a primary care physician within the MGH practice based research network
  * Live in an area where Community Servings can deliver meals
  * Ability to store and prepare Community Servings meals

Exclusion Criteria:

* • Must not be pregnant or planning pregnancy in the next year

  * Currently enrolled in another diabetes study Food allergy that would prohibit consumption of meals
  * Receiving episodic treatments that may increase blood glucose levels (e.g. prednisone)

Primary outcomes:
measure: Healthy Eating Index 2010 Score
timeFrame: Average of 3 24-hour food recalls per study period (on and off meals; one in-person visit and 2 over the phone at 4 and 8 weeks into the study)
Secondary outcomes:
measure: Number of Participants With Food Insecurity
timeFrame: Measured at end of On-Meals Period and end of Off-Meals Period for each participant
measure: Diabetes Distress Scale
timeFrame: Measured at end of On-Meals Period and end of Off-Meals Period for each participant
Other outcomes:
measure: Hemoglobin A1c
timeFrame: Measured at end of On-Meals Period and end of Off-Meals Period for each participant
measure: LDL Cholesterol
timeFrame: Measured at end of On-Meals Period and end of Off-Meals Period for each participant
measure: Body Mass Index
timeFrame: Measured at end of On-Meals Period and end of Off-Meals Period for each participant
measure: Systolic Blood Pressure
timeFrame: Measured at end of On-Meals Period and end of Off-Meals Period for each participant using a calibrated sphygmomanometer
measure: Diastolic Blood Pressure
timeFrame: Measured at end of On-Meals Period and end of Off-Meals Period for each participant using a calibrated sphygmomanometer
measure: Change From Baseline in Medication Adherence
timeFrame: Measured at end of On-Meals Period and end of Off-Meals Period for each participant
measure: Number of Participants With Cost Related Medication Under-Use
timeFrame: Measured at end of On-Meals Period and end of Off-Meals Period for each participant
measure: Number of Participants With Food and Medication Trade-offs
timeFrame: Measured at end of On-Meals Period and end of Off-Meals Period for each participant
measure: Depressive Symptoms (Assessed Using the PHQ-8 Scale)
timeFrame: Measured at end of On-Meals Period and end of Off-Meals Period for each participant
measure: Change From Baseline in Cognitive Burden (Assessed Using Times on the Stroop Task)
timeFrame: Measured at end of On-Meals Period and end of Off-Meals Period for each participant
measure: Number of Participants With Self-reported Hypoglycemia
timeFrame: Measured at end of On-Meals Period and end of Off-Meals Period for each participant
measure: Triglycerides
timeFrame: Measured at end of On-Meals Period and end of Off-Meals Period for each participant by fasting blood draw
measure: HDL Cholesterol
timeFrame: Measured at end of On-Meals Period and end of Off-Meals Period for each participant by fasting blood draw
measure: Total Cholesterol
timeFrame: Measured at end of On-Meals Period and end of Off-Meals Period for each participant by fasting blood draw
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Seth A Berkowitz, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Berkowitz SA, Delahanty LM, Terranova J, Steiner B, Ruazol MP, Singh R, Shahid NN, Wexler DJ. Medically Tailored Meal Delivery for Diabetes Patients with Food Insecurity: a Randomized Cross-over Trial. J Gen Intern Med. 2019 Mar;34(3):396-404. doi: 10.1007/s11606-018-4716-z. Epub 2018 Nov 12.
citation: Berkowitz SA, Shahid NN, Terranova J, Steiner B, Ruazol MP, Singh R, Delahanty LM, Wexler DJ. "I was able to eat what I am supposed to eat"-- patient reflections on a medically-tailored meal intervention: a qualitative analysis. BMC Endocr Disord. 2020 Jan 20;20(1):10. doi: 10.1186/s12902-020-0491-z.