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Community Servings: Food as Medicine for Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02426138
Recruitment Status : Completed
First Posted : April 24, 2015
Results First Posted : October 30, 2019
Last Update Posted : October 30, 2019
Sponsor:
Information provided by (Responsible Party):
Seth A Berkowitz, Massachusetts General Hospital

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.


Condition or disease Intervention/treatment Phase
Diabetes Other: Medically Tailored Meal Delivery (MTM) Other: Usual Care + Choose MyPlate Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Community Servings: Food as Medicine for Diabetes
Actual Study Start Date : April 1, 2015
Actual Primary Completion Date : July 31, 2017
Actual Study Completion Date : July 31, 2017

Arm Intervention/treatment
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)
Patients will receive delivery of medically tailored meals for 12 weeks

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

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




Primary Outcome Measures :
  1. Healthy Eating Index 2010 Score [ 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) ]
    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


Secondary Outcome Measures :
  1. Number of Participants With Food Insecurity [ Time Frame: 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

  2. Diabetes Distress Scale [ Time Frame: 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


Other Outcome Measures:
  1. Hemoglobin A1c [ Time Frame: 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

  2. LDL Cholesterol [ Time Frame: 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

  3. Body Mass Index [ Time Frame: 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.


  4. Systolic Blood Pressure [ Time Frame: 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.

  5. Diastolic Blood Pressure [ Time Frame: 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.

  6. Change From Baseline in Medication Adherence [ Time Frame: 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

  7. Number of Participants With Cost Related Medication Under-Use [ Time Frame: 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)

  8. Number of Participants With Food and Medication Trade-offs [ Time Frame: 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

  9. Depressive Symptoms (Assessed Using the PHQ-8 Scale) [ Time Frame: 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

  10. Change From Baseline in Cognitive Burden (Assessed Using Times on the Stroop Task) [ Time Frame: 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

  11. Number of Participants With Self-reported Hypoglycemia [ Time Frame: 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

  12. Triglycerides [ Time Frame: 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

  13. HDL Cholesterol [ Time Frame: 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

  14. Total Cholesterol [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02426138


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Principal Investigator: Seth A Berkowitz, MD MPH Massachusetts General Hospital
  Study Documents (Full-Text)

Documents provided by Seth A Berkowitz, Massachusetts General Hospital:
Publications of Results:
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Responsible Party: Seth A Berkowitz, Instructor in Medicine, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02426138    
Other Study ID Numbers: 2014P002778
First Posted: April 24, 2015    Key Record Dates
Results First Posted: October 30, 2019
Last Update Posted: October 30, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases