Effect of Medically-tailored Meal Delivery Service on Changes in Hemoglobin A1c (HbA1c) in Patients With Diabetes
1 other identifier
interventional
34
1 country
2
Brief Summary
The purpose of this study is to evaluate the effect of medically-tailored meal delivery (10 meals per week for 3 months) on glycemic control in diabetic patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable type-2-diabetes
Started Aug 2020
Shorter than P25 for not_applicable type-2-diabetes
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 19, 2020
CompletedFirst Posted
Study publicly available on registry
August 21, 2020
CompletedStudy Start
First participant enrolled
August 24, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 4, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 4, 2021
CompletedJuly 12, 2021
July 1, 2021
9 months
August 19, 2020
July 9, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Glucose Metabolism
Measured by HbA1c levels in standard chemistry in blood
Baseline, 3 monts
Secondary Outcomes (5)
Change in Weight
Baseline, 3 months
Change in Blood Pressure
Baseline, 3 months
Change in High Density lipoprotein (HDL)
Baseline, 3 months
Change in Low Density Lipoprotein (LDL)
Baseline, 3 months
Change in Triglycerides
Baseline, 3 months
Study Arms (2)
Treatment Sequence AB
EXPERIMENTALParticipants 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.
Treatment Sequence BA
EXPERIMENTALParticipants 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.
Interventions
10 meals per week for 3 months
Eligibility Criteria
You may qualify if:
- Adult men and women with non-insulin dependent diabetes.
- 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%.
You may not qualify if:
- Insulin use.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (2)
Mayo Clinic in Florida
Jacksonville, Florida, 32224, United States
Mayo Clinic
Jacksonville, Florida, 32224, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bryan Farford, DO
Mayo Clinic
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 19, 2020
First Posted
August 21, 2020
Study Start
August 24, 2020
Primary Completion
June 4, 2021
Study Completion
June 4, 2021
Last Updated
July 12, 2021
Record last verified: 2021-07
Data Sharing
- IPD Sharing
- Will not share