Effect of Medically-tailored Meal Delivery Service on Changes in Hemoglobin A1c (HbA1c) in Patients With Diabetes
NCT ID: NCT04523155
Last Updated: 2021-07-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
34 participants
INTERVENTIONAL
2020-08-24
2021-06-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
NONE
Study Groups
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Treatment Sequence AB
Participants randomized to sequence AB will receive 3 months of meals, followed by a 3 month washout period and a 3 month intervention period with no meals.
Medically tailored meals
10 meals per week for 3 months
Treatment Sequence BA
Participants randomized to sequence BA will receive 3 months of no meals followed by a 3 month washout period and a 3 month intervention period with meals.
Medically tailored meals
10 meals per week for 3 months
Interventions
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Medically tailored meals
10 meals per week for 3 months
Eligibility Criteria
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Inclusion Criteria
* Ages 25 to 75 years.
* Fasting blood sugar of greater than 140 mg/dl, on no oral hypoglycemic agents and a hemoglobin A1C less than 13%.
* Stabilized patients on oral hypoglycemic agents for one month or longer prior to starting the study and a hemoglobin A1C between 7.5% - 13%.
Exclusion Criteria
* Substance abuse.
* Any documented medical problem that would inhibit full participation in the study.
* BMI less than 25 or great than 40.
* Vegans or Vegetarians
* Individuals with food allergies.
* Individuals currently on a commercial weight loss or diet program.
25 Years
75 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Bryan Farford
Principal Investigator
Principal Investigators
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Bryan Farford, DO
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic in Florida
Jacksonville, Florida, United States
Mayo Clinic
Jacksonville, Florida, United States
Countries
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Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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20-004608
Identifier Type: -
Identifier Source: org_study_id
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