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NCT02426138 · ClinicalTrials.gov registry record · NA
Community Servings: Food as Medicine for Diabetes
A NA study of Diabetes, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- NA
- Development phase
- 44
- Enrollment target
- 1
- Study location
NCT02426138: Completed NA study of Diabetes, sponsored by Massachusetts General Hospital.
NCT02426138 is a NA study of Diabetes that has completed, run by Massachusetts General Hospital. The registered enrollment target is 44 participants, below the 3,028-participant average among 338 other Diabetes trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02426138, a NA study of Diabetes, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 44 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
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
Conditions Studied
Interventions
- OTHER Medically Tailored Meal Delivery (MTM)
- OTHER Usual Care + Choose MyPlate
Study Locations (1)
Massachusetts
- Massachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2015-04-01 |
| Est. Completion | 2017-07-31 |
| Phase | NA |
What the finished NCT02426138 record still lists
NCT02426138 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 3,028-participant average among 338 other Diabetes trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Diabetes appearing as the primary indexed condition, and to 2 interventions - of which Medically Tailored Meal Delivery (MTM) is the first listed.
NCT02426138 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT02426138 about?
NCT02426138 is a clinical study titled "Community Servings: Food as Medicine for Diabetes". 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 effe...
What is the current status of trial NCT02426138?
This trial is currently completed. It is a NA study. The enrollment target is 44 participants. The study started on 2015-04-01. Estimated completion is 2017-07-31.
What conditions does trial NCT02426138 study?
This clinical trial studies the following conditions: Diabetes.
What interventions are being tested in trial NCT02426138?
The interventions under investigation include: Medically Tailored Meal Delivery (MTM) (OTHER), Usual Care + Choose MyPlate (OTHER).
Who is sponsoring clinical trial NCT02426138?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02426138 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Diabetes
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02426138's enrollment target sits among peer trials
44 257th of 338 higher than 80 of 338 other Diabetes trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetes trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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