Trial Outcomes & Findings for Community Servings: Food as Medicine for Diabetes (NCT NCT02426138)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

44 participants

Primary outcome 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)

Results posted on

2019-10-30

Participant Flow

Participant milestones

Participant milestones
Measure	Meal Delivery Then Usual Care + Choose myPlate During the first intervention period, participants in this arm will receive 12 weeks of medically tailored meal delivery, comprising approximately half of their weekly caloric intake and consisting of foods prepared under the supervision of a registered dietitian to be compatible with a diabetes diet. They will also receive usual diabetes care and a Choose MyPlate healthy eating brochure. Data recorded during or at the end of the first intervention period will comprise the 'on-meal' data for this participants in this arm. Following this, during the second intervention period, they will receive 12 weeks of usual diabetes care + a Choose MyPlate healthy eating brochure, without meal delivery. Data recorded during or at the end of the second intervention period will comprise the 'off-meal' data for participants in this arm.	Usual Care + Choose myPlate Then Meal Delivery During the first intervention period, participants in this arm will receive 12 weeks of usual diabetes care + a Choose MyPlate healthy eating brochure, without meal delivery. Data recorded during or at the end of the first intervention period will comprise the 'off-meal' data for participants in this arm. Following this, during the second intervention period, participants will receive 12 weeks of medically tailored meal delivery, comprising approximately half of their weekly caloric intake and consisting of foods prepared under the supervision of a registered dietitian to be compatible with a diabetes diet. They will also receive usual diabetes care and a Choose MyPlate healthy eating brochure. Data recorded during or at the end of the second intervention period will comprise the 'on-meal' data for this participants in this arm.
First Intervention (12 Weeks) STARTED	21	23
First Intervention (12 Weeks) COMPLETED	20	22
First Intervention (12 Weeks) NOT COMPLETED	1	1
Second Intervention (12 Weeks) STARTED	20	22
Second Intervention (12 Weeks) COMPLETED	20	22
Second Intervention (12 Weeks) NOT COMPLETED	0	0
Intent to Treat Population Milestone STARTED	20	22
Intent to Treat Population Milestone COMPLETED	20	22
Intent to Treat Population Milestone NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Meal Delivery Then Usual Care + Choose myPlate During the first intervention period, participants in this arm will receive 12 weeks of medically tailored meal delivery, comprising approximately half of their weekly caloric intake and consisting of foods prepared under the supervision of a registered dietitian to be compatible with a diabetes diet. They will also receive usual diabetes care and a Choose MyPlate healthy eating brochure. Data recorded during or at the end of the first intervention period will comprise the 'on-meal' data for this participants in this arm. Following this, during the second intervention period, they will receive 12 weeks of usual diabetes care + a Choose MyPlate healthy eating brochure, without meal delivery. Data recorded during or at the end of the second intervention period will comprise the 'off-meal' data for participants in this arm.	Usual Care + Choose myPlate Then Meal Delivery During the first intervention period, participants in this arm will receive 12 weeks of usual diabetes care + a Choose MyPlate healthy eating brochure, without meal delivery. Data recorded during or at the end of the first intervention period will comprise the 'off-meal' data for participants in this arm. Following this, during the second intervention period, participants will receive 12 weeks of medically tailored meal delivery, comprising approximately half of their weekly caloric intake and consisting of foods prepared under the supervision of a registered dietitian to be compatible with a diabetes diet. They will also receive usual diabetes care and a Choose MyPlate healthy eating brochure. Data recorded during or at the end of the second intervention period will comprise the 'on-meal' data for this participants in this arm.
First Intervention (12 Weeks) Withdrawal by Subject	1	1

Baseline Characteristics

Community Servings: Food as Medicine for Diabetes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Meal Delivery Then Usual Care + Choose myPlate n=20 Participants During the first intervention period, participants in this arm will receive 12 weeks of medically tailored meal delivery, comprising approximately half of their weekly caloric intake and consisting of foods prepared under the supervision of a registered dietitian to be compatible with a diabetes diet. They will also receive usual diabetes care and a Choose MyPlate healthy eating brochure. Data recorded during or at the end of the first intervention period will comprise the 'on-meal' data for this participants in this arm. Following this, during the second intervention period, they will receive 12 weeks of usual diabetes care + a Choose MyPlate healthy eating brochure, without meal delivery. Data recorded during or at the end of the second intervention period will comprise the 'off-meal' data for participants in this arm.	Usual Care + Choose myPlate Then Meal Delivery n=22 Participants During the first intervention period, participants in this arm will receive 12 weeks of usual diabetes care + a Choose MyPlate healthy eating brochure, without meal delivery. Data recorded during or at the end of the first intervention period will comprise the 'off-meal' data for participants in this arm. Following this, during the second intervention period, participants will receive 12 weeks of medically tailored meal delivery, comprising approximately half of their weekly caloric intake and consisting of foods prepared under the supervision of a registered dietitian to be compatible with a diabetes diet. They will also receive usual diabetes care and a Choose MyPlate healthy eating brochure. Data recorded during or at the end of the second intervention period will comprise the 'on-meal' data for this participants in this arm.	Total n=42 Participants Total of all reporting groups
Age, Continuous	57.66 years STANDARD_DEVIATION 12.25 • n=99 Participants	59.21 years STANDARD_DEVIATION 13.11 • n=107 Participants	58.5 years STANDARD_DEVIATION 12.6 • n=206 Participants
Sex: Female, Male Female	13 Participants n=99 Participants	16 Participants n=107 Participants	29 Participants n=206 Participants
Sex: Female, Male Male	7 Participants n=99 Participants	6 Participants n=107 Participants	13 Participants n=206 Participants
Race/Ethnicity, Customized Non-Hispanic White	10 Participants n=99 Participants	13 Participants n=107 Participants	23 Participants n=206 Participants
Race/Ethnicity, Customized Non-Hispanic Black	5 Participants n=99 Participants	6 Participants n=107 Participants	11 Participants n=206 Participants
Race/Ethnicity, Customized Hispanic	4 Participants n=99 Participants	3 Participants n=107 Participants	7 Participants n=206 Participants
Race/Ethnicity, Customized Other	1 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants
Region of Enrollment United States	20 participants n=99 Participants	22 participants n=107 Participants	42 participants n=206 Participants
Healthy Eating Index 2010 Score	57.27 units on a scale STANDARD_DEVIATION 14.65 • n=99 Participants	57.16 units on a scale STANDARD_DEVIATION 13.49 • n=107 Participants	57.21 units on a scale STANDARD_DEVIATION 14.04 • n=206 Participants

PRIMARY outcome

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)

Population: ITT

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

Outcome measures

Outcome measures
Measure	On Meals n=31 Participants Outcome recorded while receiving medically tailored meals	Off Meals n=39 Participants Outcome recorded while not receiving meals
Healthy Eating Index 2010 Score	71.30 units on a scale Standard Deviation 7.49	39.89 units on a scale Standard Deviation 7.80

SECONDARY outcome

Timeframe: Measured at end of On-Meals Period and end of Off-Meals Period for each participant

Population: ITT

Food insecurity is defined as \> 2 affirmative responses on the 10 adult referenced items USDA Household Food Security Survey Module

Outcome measures

Outcome measures
Measure	On Meals n=31 Participants Outcome recorded while receiving medically tailored meals	Off Meals n=39 Participants Outcome recorded while not receiving meals
Number of Participants With Food Insecurity	13 Participants	24 Participants

SECONDARY outcome

Timeframe: Measured at end of On-Meals Period and end of Off-Meals Period for each participant

Population: ITT

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

Outcome measures

Outcome measures
Measure	On Meals n=31 Participants Outcome recorded while receiving medically tailored meals	Off Meals n=34 Participants Outcome recorded while not receiving meals
Diabetes Distress Scale	30.94 units on a scale Standard Deviation 13.77	30.82 units on a scale Standard Deviation 10.70

OTHER_PRE_SPECIFIED outcome

Timeframe: Measured at end of On-Meals Period and end of Off-Meals Period for each participant

Population: ITT

This will be measured using a fasting blood draw at baseline, 12 and 24 weeks

Outcome measures

Outcome measures
Measure	On Meals n=31 Participants Outcome recorded while receiving medically tailored meals	Off Meals n=39 Participants Outcome recorded while not receiving meals
Hemoglobin A1c	7.99 % of hemoglobin Standard Deviation 1.86	8.15 % of hemoglobin Standard Deviation 1.72

OTHER_PRE_SPECIFIED outcome

Timeframe: Measured at end of On-Meals Period and end of Off-Meals Period for each participant

Population: ITT

A fasting blood draw will be used to measure: LDL Cholesterol

Outcome measures

Outcome measures
Measure	On Meals n=31 Participants Outcome recorded while receiving medically tailored meals	Off Meals n=39 Participants Outcome recorded while not receiving meals
LDL Cholesterol	97.54 mg/dl Standard Deviation 35.67	101.43 mg/dl Standard Deviation 43.11

OTHER_PRE_SPECIFIED outcome

Timeframe: Measured at end of On-Meals Period and end of Off-Meals Period for each participant

Population: ITT

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.

Outcome measures

Outcome measures
Measure	On Meals n=31 Participants Outcome recorded while receiving medically tailored meals	Off Meals n=39 Participants Outcome recorded while not receiving meals
Body Mass Index	34.24 kg/m^2 Standard Deviation 6.76	34.79 kg/m^2 Standard Deviation 6.97

OTHER_PRE_SPECIFIED outcome

Timeframe: Measured at end of On-Meals Period and end of Off-Meals Period for each participant using a calibrated sphygmomanometer

Population: ITT

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.

Outcome measures

Outcome measures
Measure	On Meals n=31 Participants Outcome recorded while receiving medically tailored meals	Off Meals n=39 Participants Outcome recorded while not receiving meals
Systolic Blood Pressure	133.04 mm hg Standard Deviation 17.60	136.00 mm hg Standard Deviation 18.77

OTHER_PRE_SPECIFIED outcome

Timeframe: Measured at end of On-Meals Period and end of Off-Meals Period for each participant using a calibrated sphygmomanometer

Population: ITT

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.

Outcome measures

Outcome measures
Measure	On Meals n=31 Participants Outcome recorded while receiving medically tailored meals	Off Meals n=39 Participants Outcome recorded while not receiving meals
Diastolic Blood Pressure	76.86 mm hg Standard Deviation 8.65	78.16 mm hg Standard Deviation 10.11

OTHER_PRE_SPECIFIED outcome

Timeframe: Measured at end of On-Meals Period and end of Off-Meals Period for each participant

Population: ITT

Change from baseline in Medication Adherence Rating Scale (Assessed using medication adherence rating scale) Range is 0-25 The higher the number the better

Outcome measures

Outcome measures
Measure	On Meals n=31 Participants Outcome recorded while receiving medically tailored meals	Off Meals n=39 Participants Outcome recorded while not receiving meals
Change From Baseline in Medication Adherence	23.19 units on a scale Standard Deviation 2.86	22.28 units on a scale Standard Deviation 3.21

OTHER_PRE_SPECIFIED outcome

Timeframe: Measured at end of On-Meals Period and end of Off-Meals Period for each participant

Population: ITT

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)

Outcome measures

Outcome measures
Measure	On Meals n=31 Participants Outcome recorded while receiving medically tailored meals	Off Meals n=39 Participants Outcome recorded while not receiving meals
Number of Participants With Cost Related Medication Under-Use	7 Participants	11 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Measured at end of On-Meals Period and end of Off-Meals Period for each participant

Population: ITT

Prevalence of food and medication trade-offs between groups

Outcome measures

Outcome measures
Measure	On Meals n=31 Participants Outcome recorded while receiving medically tailored meals	Off Meals n=39 Participants Outcome recorded while not receiving meals
Number of Participants With Food and Medication Trade-offs	9 Participants	9 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Measured at end of On-Meals Period and end of Off-Meals Period for each participant

Population: ITT

Patient Health Questionnaire - 8 item version. The score ranges 0-24, The lower score represents less depressive symptoms

Outcome measures

Outcome measures
Measure	On Meals n=31 Participants Outcome recorded while receiving medically tailored meals	Off Meals n=39 Participants Outcome recorded while not receiving meals
Depressive Symptoms (Assessed Using the PHQ-8 Scale)	6.16 units on a scale Standard Deviation 5.15	6.13 units on a scale Standard Deviation 4.96

Adverse Events

Medically Tailored Meal Delivery

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Care + Choose Myplate (Delayed)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Seth A. Berkowitz

University of North Carolina at Chapel Hill

Phone: 919-966-2276

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place