Community Servings: Food as Medicine for Diabetes

Diabetes Clinical Trial

Official title:

Community Servings: Food as Medicine for Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02426138
• Other study ID #: 2014P002778
• Status: Completed
• Phase: N/A
• Start date: April 1, 2015
• Est. completion date: July 31, 2017

Study information

• Verified date: October 2019
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: July 31, 2017
• Est. primary completion date: July 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus

Intervention

Other:
• Medically Tailored Meal Delivery (MTM)
Patients will receive delivery of medically tailored meals for 12 weeks
• Usual Care + Choose MyPlate
Patients will receive usual diabetes care + a Choose MyPlate healthy eating brochure for 12 weeks

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

References & Publications (1)

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: 10.100 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Hemoglobin A1c	This will be measured using a fasting blood draw at baseline, 12 and 24 weeks	Measured at end of On-Meals Period and end of Off-Meals Period for each participant
Other	LDL Cholesterol	A fasting blood draw will be used to measure: LDL Cholesterol	Measured at end of On-Meals Period and end of Off-Meals Period for each participant
Other	Body Mass Index	Body Mass Index will be measured in light street clothes (without shoes) using a single calibrated scale.; Height measured using a stadiometer. Body Mass Index (BMI) is a person's weight in kilograms divided by the square of height in meters.; A high BMI can be an indicator of high body fatness.	Measured at end of On-Meals Period and end of Off-Meals Period for each participant
Other	Systolic Blood Pressure	Measured using a calibrated sphygmomanometer with appropriate cuff sizes based on arm circumference. Average of 2 readings, first manual and second automated at 1 min intervals following a 5 min period of rest.	Measured at end of On-Meals Period and end of Off-Meals Period for each participant using a calibrated sphygmomanometer
Other	Diastolic Blood Pressure	Measured using a calibrated sphygmomanometer with appropriate cuff sizes based on arm circumference. Average of 2 readings, first manual and second automated at 1 min intervals following a 5 min period of rest.	Measured at end of On-Meals Period and end of Off-Meals Period for each participant using a calibrated sphygmomanometer
Other	Change From Baseline in Medication Adherence	Change from baseline in Medication Adherence Rating Scale (Assessed using medication adherence rating scale) Range is 0-25 The higher the number the better	Measured at end of On-Meals Period and end of Off-Meals Period for each participant
Other	Number of Participants With Cost Related Medication Under-Use	Cost Related Medication Under-use (Defined as > 0 affirmative responses to 4-items on cost-related medication under-use from the medication expenditure panel survey)	Measured at end of On-Meals Period and end of Off-Meals Period for each participant
Other	Number of Participants With Food and Medication Trade-offs	Prevalence of food and medication trade-offs between groups	Measured at end of On-Meals Period and end of Off-Meals Period for each participant
Other	Depressive Symptoms (Assessed Using the PHQ-8 Scale)	Patient Health Questionnaire - 8 item version. The score ranges 0-24, The lower score represents less depressive symptoms	Measured at end of On-Meals Period and end of Off-Meals Period for each participant
Other	Change From Baseline in Cognitive Burden (Assessed Using Times on the Stroop Task)	This outcome was planned to be measured but not measured owing to technical difficulties in assessment	Measured at end of On-Meals Period and end of Off-Meals Period for each participant
Other	Number of Participants With Self-reported Hypoglycemia	Report of hypoglycemia requiring assistance in last 3 months	Measured at end of On-Meals Period and end of Off-Meals Period for each participant
Other	Triglycerides	A fasting blood draw will be used to measure: Triglycerides	Measured at end of On-Meals Period and end of Off-Meals Period for each participant by fasting blood draw
Other	HDL Cholesterol	A fasting blood draw will be used to measure: HDL Cholesterol	Measured at end of On-Meals Period and end of Off-Meals Period for each participant by fasting blood draw
Other	Total Cholesterol	A fasting blood draw will be used to measure: Total Cholesterol	Measured at end of On-Meals Period and end of Off-Meals Period for each participant by fasting blood draw
Primary	Healthy Eating Index 2010 Score	Calculated using data from ASA24 24-hour dietary recall tool Healthy Eating Index 2010 Score Minimum and Maximum range = 0 to 100 Higher scores indicate better diet quality The score is an average of the three-time periods that data was collected	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	Number of Participants With Food Insecurity	Food insecurity is defined as > 2 affirmative responses on the 10 adult referenced items USDA Household Food Security Survey Module	Measured at end of On-Meals Period and end of Off-Meals Period for each participant
Secondary	Diabetes Distress Scale	Diabetes Distress calculated using the Diabetes Distress Scale Minimum and Maximum scores range of the scale is 17-106 For this measure the lower the score the better	Measured at end of On-Meals Period and end of Off-Meals Period for each participant