Community Servings: Food as Medicine for Diabetes
NCT02426138, Not applicable, Completed, Massachusetts General Hospital; results first posted 2019-10-30
Trial 12
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Community Servings: Food as Medicine for Diabetes | ClinicalTrials.gov |
| NCT number | NCT02426138 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 44 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Massachusetts General Hospital | ClinicalTrials.gov |
| Conditions | Diabetes | ClinicalTrials.gov |
| Interventions | Medically Tailored Meal Delivery (MTM), Usual Care + Choose MyPlate | ClinicalTrials.gov |
| First posted | 2015-04-24 | ClinicalTrials.gov |
| Last updated | 2019-10-30 | ClinicalTrials.gov |
| Results first posted | 2019-10-30 | ClinicalTrials.gov |
| 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 | ClinicalTrials.gov |
Registered outcomes 17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Healthy Eating Index 2010 Score | 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) | 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 | ClinicalTrials.gov |
| Secondary | Number of Participants With Food Insecurity | Measured at end of On-Meals Period and end of Off-Meals Period for each participant | Food insecurity is defined as \> 2 affirmative responses on the 10 adult referenced items USDA Household Food Security Survey Module | ClinicalTrials.gov |
| Secondary | Diabetes Distress Scale | Measured at end of On-Meals Period and end of Off-Meals Period for each participant | 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 | ClinicalTrials.gov |
| Other | Hemoglobin A1c | Measured at end of On-Meals Period and end of Off-Meals Period for each participant | This will be measured using a fasting blood draw at baseline, 12 and 24 weeks | ClinicalTrials.gov |
| Other | LDL Cholesterol | Measured at end of On-Meals Period and end of Off-Meals Period for each participant | A fasting blood draw will be used to measure: LDL Cholesterol | ClinicalTrials.gov |
| Other | Body Mass Index | Measured at end of On-Meals Period and end of Off-Meals Period for each participant | 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. | ClinicalTrials.gov |
| Other | Systolic Blood Pressure | Measured at end of On-Meals Period and end of Off-Meals Period for each participant using a calibrated sphygmomanometer | 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. | ClinicalTrials.gov |
| Other | Diastolic Blood Pressure | Measured at end of On-Meals Period and end of Off-Meals Period for each participant using a calibrated sphygmomanometer | 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. | ClinicalTrials.gov |
| Other | Change From Baseline in Medication Adherence | Measured at end of On-Meals Period and end of Off-Meals Period for each participant | Change from baseline in Medication Adherence Rating Scale (Assessed using medication adherence rating scale) Range is 0-25 The higher the number the better | ClinicalTrials.gov |
| Other | Number of Participants With Cost Related Medication Under-Use | Measured at end of On-Meals Period and end of Off-Meals Period for each participant | 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) | ClinicalTrials.gov |
| Other | Number of Participants With Food and Medication Trade-offs | Measured at end of On-Meals Period and end of Off-Meals Period for each participant | Prevalence of food and medication trade-offs between groups | ClinicalTrials.gov |
| Other | Depressive Symptoms (Assessed Using the PHQ-8 Scale) | Measured at end of On-Meals Period and end of Off-Meals Period for each participant | Patient Health Questionnaire - 8 item version. The score ranges 0-24, The lower score represents less depressive symptoms | ClinicalTrials.gov |
| Other | Change From Baseline in Cognitive Burden (Assessed Using Times on the Stroop Task) | Measured at end of On-Meals Period and end of Off-Meals Period for each participant | This outcome was planned to be measured but not measured owing to technical difficulties in assessment | ClinicalTrials.gov |
| Other | Number of Participants With Self-reported Hypoglycemia | Measured at end of On-Meals Period and end of Off-Meals Period for each participant | Report of hypoglycemia requiring assistance in last 3 months | ClinicalTrials.gov |
| Other | Triglycerides | Measured at end of On-Meals Period and end of Off-Meals Period for each participant by fasting blood draw | A fasting blood draw will be used to measure: Triglycerides | ClinicalTrials.gov |
| Other | HDL Cholesterol | Measured at end of On-Meals Period and end of Off-Meals Period for each participant by fasting blood draw | A fasting blood draw will be used to measure: HDL Cholesterol | ClinicalTrials.gov |
| Other | Total Cholesterol | Measured at end of On-Meals Period and end of Off-Meals Period for each participant by fasting blood draw | A fasting blood draw will be used to measure: Total Cholesterol | ClinicalTrials.gov |
Outcomes 17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|---|---|---|---|---|---|
| PRIMARY | Healthy Eating Index 2010 Score | 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) | ITT | units on a scale | MEAN | ClinicalTrials.gov |
| SECONDARY | Number of Participants With Food Insecurity | Measured at end of On-Meals Period and end of Off-Meals Period for each participant | ITT | Participants | COUNT_OF_PARTICIPANTS | ClinicalTrials.gov |
| SECONDARY | Diabetes Distress Scale | Measured at end of On-Meals Period and end of Off-Meals Period for each participant | ITT | units on a scale | MEAN | ClinicalTrials.gov |
| OTHER_PRE_SPECIFIED | Hemoglobin A1c | Measured at end of On-Meals Period and end of Off-Meals Period for each participant | ITT | % of hemoglobin | MEAN | ClinicalTrials.gov |
| OTHER_PRE_SPECIFIED | LDL Cholesterol | Measured at end of On-Meals Period and end of Off-Meals Period for each participant | ITT | mg/dl | MEAN | ClinicalTrials.gov |
| OTHER_PRE_SPECIFIED | Body Mass Index | Measured at end of On-Meals Period and end of Off-Meals Period for each participant | ITT | kg/m^2 | MEAN | ClinicalTrials.gov |
| OTHER_PRE_SPECIFIED | Systolic Blood Pressure | Measured at end of On-Meals Period and end of Off-Meals Period for each participant using a calibrated sphygmomanometer | ITT | mm hg | MEAN | ClinicalTrials.gov |
| OTHER_PRE_SPECIFIED | Diastolic Blood Pressure | Measured at end of On-Meals Period and end of Off-Meals Period for each participant using a calibrated sphygmomanometer | ITT | mm hg | MEAN | ClinicalTrials.gov |
| OTHER_PRE_SPECIFIED | Change From Baseline in Medication Adherence | Measured at end of On-Meals Period and end of Off-Meals Period for each participant | ITT | units on a scale | MEAN | ClinicalTrials.gov |
| OTHER_PRE_SPECIFIED | Number of Participants With Cost Related Medication Under-Use | Measured at end of On-Meals Period and end of Off-Meals Period for each participant | ITT | Participants | COUNT_OF_PARTICIPANTS | ClinicalTrials.gov |
| OTHER_PRE_SPECIFIED | Number of Participants With Food and Medication Trade-offs | Measured at end of On-Meals Period and end of Off-Meals Period for each participant | ITT | Participants | COUNT_OF_PARTICIPANTS | ClinicalTrials.gov |
| OTHER_PRE_SPECIFIED | Depressive Symptoms (Assessed Using the PHQ-8 Scale) | Measured at end of On-Meals Period and end of Off-Meals Period for each participant | ITT | units on a scale | MEAN | ClinicalTrials.gov |
| OTHER_PRE_SPECIFIED | Change From Baseline in Cognitive Burden (Assessed Using Times on the Stroop Task) | Measured at end of On-Meals Period and end of Off-Meals Period for each participant | This outcome was planned to be measured but not measured owing to technical difficulties in assessment | ClinicalTrials.gov | ||
| OTHER_PRE_SPECIFIED | Number of Participants With Self-reported Hypoglycemia | Measured at end of On-Meals Period and end of Off-Meals Period for each participant | ITT | Participants | COUNT_OF_PARTICIPANTS | ClinicalTrials.gov |
| OTHER_PRE_SPECIFIED | Triglycerides | Measured at end of On-Meals Period and end of Off-Meals Period for each participant by fasting blood draw | ITT | mg/dl | MEDIAN | ClinicalTrials.gov |
| OTHER_PRE_SPECIFIED | HDL Cholesterol | Measured at end of On-Meals Period and end of Off-Meals Period for each participant by fasting blood draw | ITT | mg/dl | MEAN | ClinicalTrials.gov |
| OTHER_PRE_SPECIFIED | Total Cholesterol | Measured at end of On-Meals Period and end of Off-Meals Period for each participant by fasting blood draw | ITT | mg/dl | MEAN | ClinicalTrials.gov |
Results by group 32
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|---|---|---|---|---|---|
| Healthy Eating Index 2010 Score | On Meals | 71.30 | Standard Deviation 7.49 | units on a scale | ClinicalTrials.gov | |
| Healthy Eating Index 2010 Score | Off Meals | 39.89 | Standard Deviation 7.80 | units on a scale | ClinicalTrials.gov | |
| Number of Participants With Food Insecurity | On-Meals | 13 | Participants | ClinicalTrials.gov | ||
| Number of Participants With Food Insecurity | Off-Meals | 24 | Participants | ClinicalTrials.gov | ||
| Diabetes Distress Scale | On-Meals | 30.94 | Standard Deviation 13.77 | units on a scale | ClinicalTrials.gov | |
| Diabetes Distress Scale | Off-Meals | 30.82 | Standard Deviation 10.70 | units on a scale | ClinicalTrials.gov | |
| Hemoglobin A1c | On-Meals | 7.99 | Standard Deviation 1.86 | % of hemoglobin | ClinicalTrials.gov | |
| Hemoglobin A1c | Off-Meals | 8.15 | Standard Deviation 1.72 | % of hemoglobin | ClinicalTrials.gov | |
| LDL Cholesterol | On-Meals | 97.54 | Standard Deviation 35.67 | mg/dl | ClinicalTrials.gov | |
| LDL Cholesterol | Off-Meals | 101.43 | Standard Deviation 43.11 | mg/dl | ClinicalTrials.gov | |
| Body Mass Index | On-Meals | 34.24 | Standard Deviation 6.76 | kg/m^2 | ClinicalTrials.gov | |
| Body Mass Index | Off-Meals | 34.79 | Standard Deviation 6.97 | kg/m^2 | ClinicalTrials.gov | |
| Systolic Blood Pressure | On-Meals | 133.04 | Standard Deviation 17.60 | mm hg | ClinicalTrials.gov | |
| Systolic Blood Pressure | Off-Meals | 136.00 | Standard Deviation 18.77 | mm hg | ClinicalTrials.gov | |
| Diastolic Blood Pressure | On-Meals | 76.86 | Standard Deviation 8.65 | mm hg | ClinicalTrials.gov | |
| Diastolic Blood Pressure | Off-Meals | 78.16 | Standard Deviation 10.11 | mm hg | ClinicalTrials.gov | |
| Change From Baseline in Medication Adherence | On-Meals | 23.19 | Standard Deviation 2.86 | units on a scale | ClinicalTrials.gov | |
| Change From Baseline in Medication Adherence | Off-Meals | 22.28 | Standard Deviation 3.21 | units on a scale | ClinicalTrials.gov | |
| Number of Participants With Cost Related Medication Under-Use | On-Meals | 7 | Participants | ClinicalTrials.gov | ||
| Number of Participants With Cost Related Medication Under-Use | Off-Meals | 11 | Participants | ClinicalTrials.gov |
Participant flow 18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|---|---|---|---|---|
| First Intervention (12 Weeks) | STARTED | Meal Delivery Then Usual Care + Choose myPlate | 21 | ClinicalTrials.gov | |
| First Intervention (12 Weeks) | STARTED | Usual Care + Choose myPlate Then Meal Delivery | 23 | ClinicalTrials.gov | |
| First Intervention (12 Weeks) | COMPLETED | Meal Delivery Then Usual Care + Choose myPlate | 20 | ClinicalTrials.gov | |
| First Intervention (12 Weeks) | COMPLETED | Usual Care + Choose myPlate Then Meal Delivery | 22 | ClinicalTrials.gov | |
| First Intervention (12 Weeks) | NOT COMPLETED | Meal Delivery Then Usual Care + Choose myPlate | 1 | ClinicalTrials.gov | |
| First Intervention (12 Weeks) | NOT COMPLETED | Usual Care + Choose myPlate Then Meal Delivery | 1 | ClinicalTrials.gov | |
| Second Intervention (12 Weeks) | STARTED | Meal Delivery Then Usual Care + Choose myPlate | 20 | ClinicalTrials.gov | |
| Second Intervention (12 Weeks) | STARTED | Usual Care + Choose myPlate Then Meal Delivery | 22 | ClinicalTrials.gov | |
| Second Intervention (12 Weeks) | COMPLETED | Meal Delivery Then Usual Care + Choose myPlate | 20 | ClinicalTrials.gov | |
| Second Intervention (12 Weeks) | COMPLETED | Usual Care + Choose myPlate Then Meal Delivery | 22 | ClinicalTrials.gov | |
| Second Intervention (12 Weeks) | NOT COMPLETED | Meal Delivery Then Usual Care + Choose myPlate | 0 | ClinicalTrials.gov | |
| Second Intervention (12 Weeks) | NOT COMPLETED | Usual Care + Choose myPlate Then Meal Delivery | 0 | ClinicalTrials.gov | |
| Intent to Treat Population Milestone | STARTED | Meal Delivery Then Usual Care + Choose myPlate | 20 | ClinicalTrials.gov | |
| Intent to Treat Population Milestone | STARTED | Usual Care + Choose myPlate Then Meal Delivery | 22 | ClinicalTrials.gov | |
| Intent to Treat Population Milestone | COMPLETED | Meal Delivery Then Usual Care + Choose myPlate | 20 | ClinicalTrials.gov | |
| Intent to Treat Population Milestone | COMPLETED | Usual Care + Choose myPlate Then Meal Delivery | 22 | ClinicalTrials.gov | |
| Intent to Treat Population Milestone | NOT COMPLETED | Meal Delivery Then Usual Care + Choose myPlate | 0 | ClinicalTrials.gov | |
| Intent to Treat Population Milestone | NOT COMPLETED | Usual Care + Choose myPlate Then Meal Delivery | 0 | ClinicalTrials.gov |
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 6
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|---|---|---|---|
| Total, all-cause mortality | Medically Tailored Meal Delivery | 0 | 42 | ClinicalTrials.gov |
| Total, all-cause mortality | Usual Care + Choose Myplate (Delayed) | 0 | 42 | ClinicalTrials.gov |
| Total, other adverse events | Medically Tailored Meal Delivery | 0 | 42 | ClinicalTrials.gov |
| Total, other adverse events | Usual Care + Choose Myplate (Delayed) | 0 | 42 | ClinicalTrials.gov |
| Total, serious adverse events | Medically Tailored Meal Delivery | 0 | 42 | ClinicalTrials.gov |
| Total, serious adverse events | Usual Care + Choose Myplate (Delayed) | 0 | 42 | ClinicalTrials.gov |
Papers 2
The papers the trial lists on ClinicalTrials.gov.
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 6
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| On-Meals vs Off-Meals: Number of Participants With Food and Medication Trade-offs | Trial comparisons |
| On-Meals vs Off-Meals: Number of Participants With Food Insecurity | Trial comparisons |
| On-Meals vs Off-Meals: Number of Participants With Self-reported Hypoglycemia | Trial comparisons |
| On-Meals vs Off-Meals: Number of Participants With Cost Related Medication Under-Use | Trial comparisons |
| Medically Tailored Meal Delivery vs Usual Care + Choose Myplate (Delayed): deaths from any cause | Trial comparisons |
| Medically Tailored Meal Delivery vs Usual Care + Choose Myplate (Delayed): serious adverse events | Trial comparisons |
Tests 1
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Stroop Color-Word Test | Other outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)