CClinicalTrials.gg
CompletedNCT02426138Updated Oct 30, 2019Results posted

Community Servings: Food as Medicine for Diabetes

An interventional study of Medically Tailored Meal Delivery (MTM) and Usual Care + Choose MyPlate in Diabetes, sponsored by Massachusetts General Hospital. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-10-30.

Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
44
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Diabetes

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03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 44 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.

Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
44 participants (actual)

Study arms

  • Experimental
    Med. Tailored Meal Delivery, Usual Care + Choose Myplate

    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 for 12 weeks.

    Other: Medically Tailored Meal Delivery (MTM) · Other: Usual Care + Choose MyPlate

  • Active comparator
    Usual Care + Choose Myplate, Med. Tailored Meal Delivery

    Participants will receive usual diabetes care and a Choose MyPlate healthy eating brochure for 12 weeks.

    Other: Usual Care + Choose MyPlate

Interventions

  • OtherMedically Tailored Meal Delivery (MTM)

    Patients will receive delivery of medically tailored meals for 12 weeks

  • OtherUsual Care + Choose MyPlate

    Patients will receive usual diabetes care + a Choose MyPlate healthy eating brochure for 12 weeks

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 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

  1. 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

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

  2. 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

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

Other outcomes

  1. Hemoglobin A1c

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

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

  2. LDL Cholesterol

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

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

  3. 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.

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

  4. 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.

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

  5. 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.

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

  6. 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

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

  7. 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)

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

  8. Number of Participants With Food and Medication Trade-offs

    Prevalence of food and medication trade-offs between groups

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

  9. 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

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

  10. 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

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

  11. Number of Participants With Self-reported Hypoglycemia

    Report of hypoglycemia requiring assistance in last 3 months

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

  12. Triglycerides

    A fasting blood draw will be used to measure: Triglycerides

    Time frame: Measured at end of On-Meals Period and end of Off-Meals Period for each participant by fasting blood draw

  13. HDL Cholesterol

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

    Time frame: Measured at end of On-Meals Period and end of Off-Meals Period for each participant by fasting blood draw

  14. Total Cholesterol

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

    Time frame: Measured at end of On-Meals Period and end of Off-Meals Period for each participant by fasting blood draw

07

Results

Posted Oct 30, 2019
Limitations and caveats
Short-term study designed to test change in diet quality only. Not designed for clinical endpoints Single center study in one region of US

Participant flow

First Intervention (12 Weeks)
Participant flow — First Intervention (12 Weeks)
MilestoneMeal Delivery Then Usual Care + Choose myPlateUsual Care + Choose myPlate Then Meal Delivery
Started2123
Completed2022
Not completed11
Withdrew: Withdrawal by subject11
Second Intervention (12 Weeks)
Participant flow — Second Intervention (12 Weeks)
MilestoneMeal Delivery Then Usual Care + Choose myPlateUsual Care + Choose myPlate Then Meal Delivery
Started2022
Completed2022
Not completed00
Intent to Treat Population Milestone
Participant flow — Intent to Treat Population Milestone
MilestoneMeal Delivery Then Usual Care + Choose myPlateUsual Care + Choose myPlate Then Meal Delivery
Started2022
Completed2022
Not completed00

Outcome measures

PrimaryHealthy 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

Time frame:
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)
Reported as:
Mean · units on a scale
Healthy Eating Index 2010 Score
units on a scaleOn MealsOff Meals
Healthy Eating Index 2010 Score71.30 ± 7.4939.89 ± 7.80
SecondaryNumber 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

Time frame:
Measured at end of On-Meals Period and end of Off-Meals Period for each participant
Reported as:
Count of participants · Participants
Number of Participants With Food Insecurity
ParticipantsOn-MealsOff-Meals
Number of Participants With Food Insecurity1324
SecondaryDiabetes 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

Time frame:
Measured at end of On-Meals Period and end of Off-Meals Period for each participant
Reported as:
Mean · units on a scale
Diabetes Distress Scale
units on a scaleOn-MealsOff-Meals
Diabetes Distress Scale30.94 ± 13.7730.82 ± 10.70
Other pre-specifiedHemoglobin A1c

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

Time frame:
Measured at end of On-Meals Period and end of Off-Meals Period for each participant
Reported as:
Mean · % of hemoglobin
Hemoglobin A1c
% of hemoglobinOn-MealsOff-Meals
Hemoglobin A1c7.99 ± 1.868.15 ± 1.72
Other pre-specifiedLDL Cholesterol

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

Time frame:
Measured at end of On-Meals Period and end of Off-Meals Period for each participant
Reported as:
Mean · mg/dl
LDL Cholesterol
mg/dlOn-MealsOff-Meals
LDL Cholesterol97.54 ± 35.67101.43 ± 43.11
Other pre-specifiedBody 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.

Time frame:
Measured at end of On-Meals Period and end of Off-Meals Period for each participant
Reported as:
Mean · kg/m^2
Body Mass Index
kg/m^2On-MealsOff-Meals
Body Mass Index34.24 ± 6.7634.79 ± 6.97
Other pre-specifiedSystolic 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.

Time frame:
Measured at end of On-Meals Period and end of Off-Meals Period for each participant using a calibrated sphygmomanometer
Reported as:
Mean · mm hg
Systolic Blood Pressure
mm hgOn-MealsOff-Meals
Systolic Blood Pressure133.04 ± 17.60136.00 ± 18.77
Other pre-specifiedDiastolic 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.

Time frame:
Measured at end of On-Meals Period and end of Off-Meals Period for each participant using a calibrated sphygmomanometer
Reported as:
Mean · mm hg
Diastolic Blood Pressure
mm hgOn-MealsOff-Meals
Diastolic Blood Pressure76.86 ± 8.6578.16 ± 10.11
Other pre-specifiedChange 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

Time frame:
Measured at end of On-Meals Period and end of Off-Meals Period for each participant
Reported as:
Mean · units on a scale
Change From Baseline in Medication Adherence
units on a scaleOn-MealsOff-Meals
Change From Baseline in Medication Adherence23.19 ± 2.8622.28 ± 3.21
Other pre-specifiedNumber 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)

Time frame:
Measured at end of On-Meals Period and end of Off-Meals Period for each participant
Reported as:
Count of participants · Participants
Number of Participants With Cost Related Medication Under-Use
ParticipantsOn-MealsOff-Meals
Number of Participants With Cost Related Medication Under-Use711
Other pre-specifiedNumber of Participants With Food and Medication Trade-offs

Prevalence of food and medication trade-offs between groups

Time frame:
Measured at end of On-Meals Period and end of Off-Meals Period for each participant
Reported as:
Count of participants · Participants
Number of Participants With Food and Medication Trade-offs
ParticipantsOn-MealsOff-Meals
Number of Participants With Food and Medication Trade-offs99
Other pre-specifiedDepressive 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

Time frame:
Measured at end of On-Meals Period and end of Off-Meals Period for each participant
Reported as:
Mean · units on a scale
Depressive Symptoms (Assessed Using the PHQ-8 Scale)
units on a scaleOn-MealsOff-Meals
Depressive Symptoms (Assessed Using the PHQ-8 Scale)6.16 ± 5.156.13 ± 4.96
Other pre-specifiedChange 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

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

No measurements were reported for this outcome.

Other pre-specifiedNumber of Participants With Self-reported Hypoglycemia

Report of hypoglycemia requiring assistance in last 3 months

Time frame:
Measured at end of On-Meals Period and end of Off-Meals Period for each participant
Reported as:
Count of participants · Participants
Number of Participants With Self-reported Hypoglycemia
ParticipantsOn-MealsOff-Meals
Number of Participants With Self-reported Hypoglycemia1423
Other pre-specifiedTriglycerides

A fasting blood draw will be used to measure: Triglycerides

Time frame:
Measured at end of On-Meals Period and end of Off-Meals Period for each participant by fasting blood draw
Reported as:
Median · mg/dl
Triglycerides
mg/dlOn MealsOff Meals
Triglycerides142.00 (83.00 to 258.00)127.50 (99.5 to 175.5)
Other pre-specifiedHDL Cholesterol

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

Time frame:
Measured at end of On-Meals Period and end of Off-Meals Period for each participant by fasting blood draw
Reported as:
Mean · mg/dl
HDL Cholesterol
mg/dlOn MealsOff Meals
HDL Cholesterol45.81 ± 11.2346.36 ± 10.20
Other pre-specifiedTotal Cholesterol

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

Time frame:
Measured at end of On-Meals Period and end of Off-Meals Period for each participant by fasting blood draw
Reported as:
Mean · mg/dl
Total Cholesterol
mg/dlOn MealsOff Meals
Total Cholesterol182.63 ± 47.30178.69 ± 43.82

Adverse events

Collected over 24 weeks. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Medically Tailored Meal Delivery0/42 (0%)0/42 (0%)0/42 (0%)
Usual Care + Choose Myplate (Delayed)0/42 (0%)0/42 (0%)0/42 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Meal Delivery Then Usual Care + Choose myPlateUsual Care + Choose myPlate Then Meal DeliveryTotal
Mean57.66 ± 12.2559.21 ± 13.1158.5 ± 12.6
Sex: Female, Male
Sex: Female, Male(Participants)Meal Delivery Then Usual Care + Choose myPlateUsual Care + Choose myPlate Then Meal DeliveryTotal
Female131629
Male7613
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Meal Delivery Then Usual Care + Choose myPlateUsual Care + Choose myPlate Then Meal DeliveryTotal
Non-Hispanic White101323
Non-Hispanic Black5611
Hispanic437
Other101
Region of Enrollment
Region of Enrollment(participants)Meal Delivery Then Usual Care + Choose myPlateUsual Care + Choose myPlate Then Meal DeliveryTotal
United States202242
Healthy Eating Index 2010 Score
Healthy Eating Index 2010 Score(units on a scale)Meal Delivery Then Usual Care + Choose myPlateUsual Care + Choose myPlate Then Meal DeliveryTotal
Mean57.27 ± 14.6557.16 ± 13.4957.21 ± 14.04
08

Study locations

1 site
  • Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
09

References and documents

Publications

  • 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. PubMed 30421335 ↗
  • 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. PubMed 31959176 ↗

Study documents

  • Protocol and statistical analysis plan · Apr 19, 2015

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 30, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02426138
Lead sponsor
Massachusetts General Hospital
Responsible party
Seth A Berkowitz (Instructor in Medicine, Massachusetts General Hospital) — Principal investigator
First posted
Apr 24, 2015
Start date
Apr 1, 2015
Primary completion
Jul 31, 2017
Completion
Jul 31, 2017
Results posted
Oct 30, 2019
Last update
Oct 30, 2019

Study contacts

Seth A Berkowitz, MD MPH
principal investigator · Massachusetts General Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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