Trial Outcomes & Findings for Food As MedicinE for Diabetes (NCT NCT04828785)
NCT ID: NCT04828785
Last Updated: 2026-09-02
Results Overview
Hemoglobin A1c Level
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
215 participants
Primary outcome timeframe
6 months
Results posted on
2026-09-02
Participant Flow
Of 215 consented individuals, 7 individuals withdrew prior to randomization and 14 individuals could not be reached for initial study visit and were not randomized
Participant milestones
| Measure |
Medically Tailored Meal (MTM)
The Medically Tailored Meal (MTM) intervention consists of weekly home meal delivery; an explanation of the medical tailoring of the meals; and a 6-session telephone lifestyle intervention change program designed to complement the period of meal delivery and prepare for the period after meal delivery with behavioral and skill-building approaches to sustain the benefit of the intervention.
|
Food Subsidy
As a comparison group, those not randomized to receive the MTM intervention will receive usual care provided by their clinicians not associated with the study, plus a food subsidy ($40/month) for 6 months, along with healthy eating information to guide use of that subsidy.
|
|---|---|---|
|
Overall Study
STARTED
|
96
|
98
|
|
Overall Study
COMPLETED
|
96
|
98
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Food As MedicinE for Diabetes
Baseline characteristics by cohort
| Measure |
Medically Tailored Meal (MTM)
n=96 Participants
The Medically Tailored Meal (MTM) intervention consists of weekly home meal delivery; an explanation of the medical tailoring of the meals; and a 6-session telephone lifestyle intervention change program designed to complement the period of meal delivery and prepare for the period after meal delivery with behavioral and skill-building approaches to sustain the benefit of the intervention.
|
Food Subsidy
n=98 Participants
As a comparison group, those not randomized to receive the MTM intervention will receive usual care provided by their clinicians not associated with the study, plus a food subsidy ($40/month) for 6 months, along with healthy eating information to guide use of that subsidy.
|
Total
n=194 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Sex: Female, Male
Male
|
38 Participants
n=136 Participants
|
39 Participants
n=136 Participants
|
77 Participants
n=272 Participants
|
|
Age, Continuous
|
56.35 years
STANDARD_DEVIATION 11.00 • n=136 Participants
|
55.59 years
STANDARD_DEVIATION 12.32 • n=136 Participants
|
55.97 years
STANDARD_DEVIATION 11.66 • n=272 Participants
|
|
Sex: Female, Male
Female
|
58 Participants
n=136 Participants
|
59 Participants
n=136 Participants
|
117 Participants
n=272 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=272 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=136 Participants
|
2 Participants
n=136 Participants
|
5 Participants
n=272 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
1 Participants
n=272 Participants
|
|
Race (NIH/OMB)
Black or African American
|
30 Participants
n=136 Participants
|
26 Participants
n=136 Participants
|
56 Participants
n=272 Participants
|
|
Race (NIH/OMB)
White
|
54 Participants
n=136 Participants
|
56 Participants
n=136 Participants
|
110 Participants
n=272 Participants
|
|
Race (NIH/OMB)
More than one race
|
8 Participants
n=136 Participants
|
13 Participants
n=136 Participants
|
21 Participants
n=272 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=136 Participants
|
1 Participants
n=136 Participants
|
1 Participants
n=272 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
15 Participants
n=136 Participants
|
21 Participants
n=136 Participants
|
36 Participants
n=272 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
81 Participants
n=136 Participants
|
77 Participants
n=136 Participants
|
158 Participants
n=272 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=272 Participants
|
|
Region of Enrollment
United States
|
96 Participants
n=136 Participants
|
98 Participants
n=136 Participants
|
194 Participants
n=272 Participants
|
|
Hemoglobin A1c
|
8.43 percentage of hemoglobin
STANDARD_DEVIATION 1.67 • n=136 Participants
|
8.44 percentage of hemoglobin
STANDARD_DEVIATION 1.64 • n=136 Participants
|
8.44 percentage of hemoglobin
STANDARD_DEVIATION 1.65 • n=272 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Intention-to-treat population
Hemoglobin A1c Level
Outcome measures
| Measure |
Medically Tailored Meal (MTM)
n=96 Participants
The Medically Tailored Meal (MTM) intervention consists of weekly home meal delivery; an explanation of the medical tailoring of the meals; and a 6-session telephone lifestyle intervention change program designed to complement the period of meal delivery and prepare for the period after meal delivery with behavioral and skill-building approaches to sustain the benefit of the intervention.
|
Food Subsidy
n=98 Participants
As a comparison group, those not randomized to receive the MTM intervention will receive usual care provided by their clinicians not associated with the study, plus a food subsidy ($40/month) for 6 months, along with healthy eating information to guide use of that subsidy.
|
|---|---|---|
|
Hemoglobin A1c at Month 6
|
7.79 percentage of hemoglobin
Interval 7.49 to 8.08
|
8.27 percentage of hemoglobin
Interval 8.0 to 8.54
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Intention-to-Treat population
Hemoglobin A1c Level
Outcome measures
| Measure |
Medically Tailored Meal (MTM)
n=96 Participants
The Medically Tailored Meal (MTM) intervention consists of weekly home meal delivery; an explanation of the medical tailoring of the meals; and a 6-session telephone lifestyle intervention change program designed to complement the period of meal delivery and prepare for the period after meal delivery with behavioral and skill-building approaches to sustain the benefit of the intervention.
|
Food Subsidy
n=98 Participants
As a comparison group, those not randomized to receive the MTM intervention will receive usual care provided by their clinicians not associated with the study, plus a food subsidy ($40/month) for 6 months, along with healthy eating information to guide use of that subsidy.
|
|---|---|---|
|
Hemoglobin A1c at Month 12
|
8.04 percentage of hemoglobin
Interval 7.71 to 8.37
|
8.11 percentage of hemoglobin
Interval 7.82 to 8.39
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Intention-to-Treat population
Food Insecurity Score. Score ranges from 0-10, with higher scores indicating greater food insecurity.
Outcome measures
| Measure |
Medically Tailored Meal (MTM)
n=96 Participants
The Medically Tailored Meal (MTM) intervention consists of weekly home meal delivery; an explanation of the medical tailoring of the meals; and a 6-session telephone lifestyle intervention change program designed to complement the period of meal delivery and prepare for the period after meal delivery with behavioral and skill-building approaches to sustain the benefit of the intervention.
|
Food Subsidy
n=98 Participants
As a comparison group, those not randomized to receive the MTM intervention will receive usual care provided by their clinicians not associated with the study, plus a food subsidy ($40/month) for 6 months, along with healthy eating information to guide use of that subsidy.
|
|---|---|---|
|
Food Insecurity Score at Month 6
|
2.05 Scores on a scale
Interval 1.39 to 2.71
|
3.20 Scores on a scale
Interval 2.63 to 3.76
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Intention-to-Treat population
Food Insecurity Score. Score ranges from 0-10, with higher scores indicating greater food insecurity.
Outcome measures
| Measure |
Medically Tailored Meal (MTM)
n=96 Participants
The Medically Tailored Meal (MTM) intervention consists of weekly home meal delivery; an explanation of the medical tailoring of the meals; and a 6-session telephone lifestyle intervention change program designed to complement the period of meal delivery and prepare for the period after meal delivery with behavioral and skill-building approaches to sustain the benefit of the intervention.
|
Food Subsidy
n=98 Participants
As a comparison group, those not randomized to receive the MTM intervention will receive usual care provided by their clinicians not associated with the study, plus a food subsidy ($40/month) for 6 months, along with healthy eating information to guide use of that subsidy.
|
|---|---|---|
|
Food Insecurity Score at Month 12
|
2.69 Scores on a scale
Interval 2.02 to 3.37
|
3.07 Scores on a scale
Interval 2.48 to 3.66
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Intention-to-Treat population
The PROMIS-29 includes seven health related quality of life domains (Physical Functioning, Anxiety, Depression, Fatigue, Sleep Disturbance, Social Functioning, and Pain), and the pain domain has two subdomains (interference and intensity). Raw scores, except pain intensity, are transformed using the T-score metric based on the item response theory calibrations in which scores have a mean of 50 and standard deviation of 10 for the general population in the US. A higher PROMIS T-score implies more of the concept being measured; i.e., a higher PROMIS score on physical function indicates better functioning, whereas a higher score on depression indicates more severe depressive symptoms. These scores are then used to calculate a PROMIS-Preference (PROPr score) (PROPr scores range from -0.022 (worst) to 1.0 (best)).
Outcome measures
| Measure |
Medically Tailored Meal (MTM)
n=96 Participants
The Medically Tailored Meal (MTM) intervention consists of weekly home meal delivery; an explanation of the medical tailoring of the meals; and a 6-session telephone lifestyle intervention change program designed to complement the period of meal delivery and prepare for the period after meal delivery with behavioral and skill-building approaches to sustain the benefit of the intervention.
|
Food Subsidy
n=98 Participants
As a comparison group, those not randomized to receive the MTM intervention will receive usual care provided by their clinicians not associated with the study, plus a food subsidy ($40/month) for 6 months, along with healthy eating information to guide use of that subsidy.
|
|---|---|---|
|
Health-Related Quality of Life Score as Assessed by PROMIS (Patient-Reported Outcomes Measurement Information System)-29 at Month 6
|
0.30 score on a scale
Interval 0.25 to 0.36
|
0.31 score on a scale
Interval 0.26 to 0.35
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Intention-to-Treat population
The PROMIS-29 includes seven health related quality of life domains (Physical Functioning, Anxiety, Depression, Fatigue, Sleep Disturbance, Social Functioning, and Pain), and the pain domain has two subdomains (interference and intensity). Raw scores, except pain intensity, are transformed using the T-score metric based on the item response theory calibrations in which scores have a mean of 50 and standard deviation of 10 for the general population in the US. A higher PROMIS T-score implies more of the concept being measured; i.e., a higher PROMIS score on physical function indicates better functioning, whereas a higher score on depression indicates more severe depressive symptoms. These scores are then used to calculate a PROMIS-Preference (PROPr score) (PROPr scores range from -0.022 (worst) to 1.0 (best)).
Outcome measures
| Measure |
Medically Tailored Meal (MTM)
n=96 Participants
The Medically Tailored Meal (MTM) intervention consists of weekly home meal delivery; an explanation of the medical tailoring of the meals; and a 6-session telephone lifestyle intervention change program designed to complement the period of meal delivery and prepare for the period after meal delivery with behavioral and skill-building approaches to sustain the benefit of the intervention.
|
Food Subsidy
n=98 Participants
As a comparison group, those not randomized to receive the MTM intervention will receive usual care provided by their clinicians not associated with the study, plus a food subsidy ($40/month) for 6 months, along with healthy eating information to guide use of that subsidy.
|
|---|---|---|
|
Health-Related Quality of Life Score as Assessed by PROMIS-29 at Month 12
|
0.30 score on a scale
Interval 0.25 to 0.36
|
0.33 score on a scale
Interval 0.28 to 0.38
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Intention-to-Treat population
Score ranges from 11-55 with higher scores indicating greater diabetes distress
Outcome measures
| Measure |
Medically Tailored Meal (MTM)
n=96 Participants
The Medically Tailored Meal (MTM) intervention consists of weekly home meal delivery; an explanation of the medical tailoring of the meals; and a 6-session telephone lifestyle intervention change program designed to complement the period of meal delivery and prepare for the period after meal delivery with behavioral and skill-building approaches to sustain the benefit of the intervention.
|
Food Subsidy
n=98 Participants
As a comparison group, those not randomized to receive the MTM intervention will receive usual care provided by their clinicians not associated with the study, plus a food subsidy ($40/month) for 6 months, along with healthy eating information to guide use of that subsidy.
|
|---|---|---|
|
Diabetes Distress Score as Assessed by PAID (Problem Areas in Diabetes)-11 at Month 6
|
16.14 Scores on a scale
Interval 13.16 to 19.11
|
17.78 Scores on a scale
Interval 15.27 to 20.3
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Intention-to-Treat population
Score ranges from 11-55 with higher scores indicating greater diabetes distress
Outcome measures
| Measure |
Medically Tailored Meal (MTM)
n=96 Participants
The Medically Tailored Meal (MTM) intervention consists of weekly home meal delivery; an explanation of the medical tailoring of the meals; and a 6-session telephone lifestyle intervention change program designed to complement the period of meal delivery and prepare for the period after meal delivery with behavioral and skill-building approaches to sustain the benefit of the intervention.
|
Food Subsidy
n=98 Participants
As a comparison group, those not randomized to receive the MTM intervention will receive usual care provided by their clinicians not associated with the study, plus a food subsidy ($40/month) for 6 months, along with healthy eating information to guide use of that subsidy.
|
|---|---|---|
|
Diabetes Distress Score as Assessed by PAID-11 at Month 12
|
14.98 Scores on a scale
Interval 12.02 to 17.94
|
17.17 Scores on a scale
Interval 14.62 to 19.72
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Intention-to-Treat population
Depressive Symptoms as assessed by PROMIS SF (Short Form) v1.0 - Depression 4a. Raw scores are transformed using the T-score metric based on the item response theory calibrations in which scores have a mean of 50 and standard deviation of 10 for the general population in the US. A higher PROMIS T-score implies more of the concept being measured; i.e., a higher PROMIS score on depression indicates more severe depressive symptoms.
Outcome measures
| Measure |
Medically Tailored Meal (MTM)
n=96 Participants
The Medically Tailored Meal (MTM) intervention consists of weekly home meal delivery; an explanation of the medical tailoring of the meals; and a 6-session telephone lifestyle intervention change program designed to complement the period of meal delivery and prepare for the period after meal delivery with behavioral and skill-building approaches to sustain the benefit of the intervention.
|
Food Subsidy
n=94 Participants
As a comparison group, those not randomized to receive the MTM intervention will receive usual care provided by their clinicians not associated with the study, plus a food subsidy ($40/month) for 6 months, along with healthy eating information to guide use of that subsidy.
|
|---|---|---|
|
Depressive Symptom Score at Month 6
|
52.20 T-score
Interval 49.84 to 54.56
|
52.83 T-score
Interval 50.66 to 54.99
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Intention-to-Treat population
Depressive Symptoms as assessed by PROMIS SF v1.0 - Depression 4a. Raw scores are transformed using the T-score metric based on the item response theory calibrations in which scores have a mean of 50 and standard deviation of 10 for the general population in the US. A higher PROMIS T-score implies more of the concept being measured; i.e., a higher PROMIS score on depression indicates more severe depressive symptoms.
Outcome measures
| Measure |
Medically Tailored Meal (MTM)
n=96 Participants
The Medically Tailored Meal (MTM) intervention consists of weekly home meal delivery; an explanation of the medical tailoring of the meals; and a 6-session telephone lifestyle intervention change program designed to complement the period of meal delivery and prepare for the period after meal delivery with behavioral and skill-building approaches to sustain the benefit of the intervention.
|
Food Subsidy
n=98 Participants
As a comparison group, those not randomized to receive the MTM intervention will receive usual care provided by their clinicians not associated with the study, plus a food subsidy ($40/month) for 6 months, along with healthy eating information to guide use of that subsidy.
|
|---|---|---|
|
Depressive Symptom Score at Month 12
|
51.73 T-score
Interval 49.18 to 54.27
|
53.41 T-score
Interval 51.18 to 55.64
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Intention-to-Treat population
Reported hypoglycemia between 0 and 6 months after randomization
Outcome measures
| Measure |
Medically Tailored Meal (MTM)
n=96 Participants
The Medically Tailored Meal (MTM) intervention consists of weekly home meal delivery; an explanation of the medical tailoring of the meals; and a 6-session telephone lifestyle intervention change program designed to complement the period of meal delivery and prepare for the period after meal delivery with behavioral and skill-building approaches to sustain the benefit of the intervention.
|
Food Subsidy
n=98 Participants
As a comparison group, those not randomized to receive the MTM intervention will receive usual care provided by their clinicians not associated with the study, plus a food subsidy ($40/month) for 6 months, along with healthy eating information to guide use of that subsidy.
|
|---|---|---|
|
Number of Participants With Self-reported Hypoglycemia at Month 6
|
25 Participants
|
42 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Intention-to-Treat population
Reported hypoglycemia between 6 and 12 months after randomization
Outcome measures
| Measure |
Medically Tailored Meal (MTM)
n=96 Participants
The Medically Tailored Meal (MTM) intervention consists of weekly home meal delivery; an explanation of the medical tailoring of the meals; and a 6-session telephone lifestyle intervention change program designed to complement the period of meal delivery and prepare for the period after meal delivery with behavioral and skill-building approaches to sustain the benefit of the intervention.
|
Food Subsidy
n=98 Participants
As a comparison group, those not randomized to receive the MTM intervention will receive usual care provided by their clinicians not associated with the study, plus a food subsidy ($40/month) for 6 months, along with healthy eating information to guide use of that subsidy.
|
|---|---|---|
|
Number of Participants With Self-reported Hypoglycemia at Month 12
|
23 Participants
|
32 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Intention-to-treat population
Reported severe hypoglycemia between 0 and 6 months after randomization
Outcome measures
| Measure |
Medically Tailored Meal (MTM)
n=96 Participants
The Medically Tailored Meal (MTM) intervention consists of weekly home meal delivery; an explanation of the medical tailoring of the meals; and a 6-session telephone lifestyle intervention change program designed to complement the period of meal delivery and prepare for the period after meal delivery with behavioral and skill-building approaches to sustain the benefit of the intervention.
|
Food Subsidy
n=98 Participants
As a comparison group, those not randomized to receive the MTM intervention will receive usual care provided by their clinicians not associated with the study, plus a food subsidy ($40/month) for 6 months, along with healthy eating information to guide use of that subsidy.
|
|---|---|---|
|
Number of Participants With Self-reported Severe Hypoglycemia at Month 6
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Intention-to-Treat population
Reported severe hypoglycemia between 6 and 12 months after randomization
Outcome measures
| Measure |
Medically Tailored Meal (MTM)
n=96 Participants
The Medically Tailored Meal (MTM) intervention consists of weekly home meal delivery; an explanation of the medical tailoring of the meals; and a 6-session telephone lifestyle intervention change program designed to complement the period of meal delivery and prepare for the period after meal delivery with behavioral and skill-building approaches to sustain the benefit of the intervention.
|
Food Subsidy
n=98 Participants
As a comparison group, those not randomized to receive the MTM intervention will receive usual care provided by their clinicians not associated with the study, plus a food subsidy ($40/month) for 6 months, along with healthy eating information to guide use of that subsidy.
|
|---|---|---|
|
Number of Participants With Self-reported Severe Hypoglycemia at Month 12
|
2 Participants
|
5 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 monthsPopulation: Intention-to-Treat population
Bodyweight measured in Kg
Outcome measures
| Measure |
Medically Tailored Meal (MTM)
n=96 Participants
The Medically Tailored Meal (MTM) intervention consists of weekly home meal delivery; an explanation of the medical tailoring of the meals; and a 6-session telephone lifestyle intervention change program designed to complement the period of meal delivery and prepare for the period after meal delivery with behavioral and skill-building approaches to sustain the benefit of the intervention.
|
Food Subsidy
n=98 Participants
As a comparison group, those not randomized to receive the MTM intervention will receive usual care provided by their clinicians not associated with the study, plus a food subsidy ($40/month) for 6 months, along with healthy eating information to guide use of that subsidy.
|
|---|---|---|
|
Bodyweight at Month 6
|
102.54 Kg
Interval 97.86 to 107.22
|
101.11 Kg
Interval 96.52 to 105.69
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsPopulation: Intention-to-Treat population
Bodyweight measured in Kg
Outcome measures
| Measure |
Medically Tailored Meal (MTM)
n=96 Participants
The Medically Tailored Meal (MTM) intervention consists of weekly home meal delivery; an explanation of the medical tailoring of the meals; and a 6-session telephone lifestyle intervention change program designed to complement the period of meal delivery and prepare for the period after meal delivery with behavioral and skill-building approaches to sustain the benefit of the intervention.
|
Food Subsidy
n=98 Participants
As a comparison group, those not randomized to receive the MTM intervention will receive usual care provided by their clinicians not associated with the study, plus a food subsidy ($40/month) for 6 months, along with healthy eating information to guide use of that subsidy.
|
|---|---|---|
|
Bodyweight at Month 12
|
101.71 Kg
Interval 96.97 to 106.44
|
100.26 Kg
Interval 95.65 to 104.86
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 monthsPopulation: Intention-to-Treat population
Systolic blood pressure in mm Hg
Outcome measures
| Measure |
Medically Tailored Meal (MTM)
n=96 Participants
The Medically Tailored Meal (MTM) intervention consists of weekly home meal delivery; an explanation of the medical tailoring of the meals; and a 6-session telephone lifestyle intervention change program designed to complement the period of meal delivery and prepare for the period after meal delivery with behavioral and skill-building approaches to sustain the benefit of the intervention.
|
Food Subsidy
n=98 Participants
As a comparison group, those not randomized to receive the MTM intervention will receive usual care provided by their clinicians not associated with the study, plus a food subsidy ($40/month) for 6 months, along with healthy eating information to guide use of that subsidy.
|
|---|---|---|
|
Systolic Blood Pressure at Month 6
|
124.37 mm Hg
Interval 120.33 to 128.41
|
130.33 mm Hg
Interval 126.47 to 134.19
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsPopulation: Intention-to-Treat population
Systolic blood pressure in mm Hg
Outcome measures
| Measure |
Medically Tailored Meal (MTM)
n=96 Participants
The Medically Tailored Meal (MTM) intervention consists of weekly home meal delivery; an explanation of the medical tailoring of the meals; and a 6-session telephone lifestyle intervention change program designed to complement the period of meal delivery and prepare for the period after meal delivery with behavioral and skill-building approaches to sustain the benefit of the intervention.
|
Food Subsidy
n=98 Participants
As a comparison group, those not randomized to receive the MTM intervention will receive usual care provided by their clinicians not associated with the study, plus a food subsidy ($40/month) for 6 months, along with healthy eating information to guide use of that subsidy.
|
|---|---|---|
|
Systolic Blood Pressure at Month 12
|
128.25 mm Hg
Interval 124.03 to 132.46
|
129.03 mm Hg
Interval 125.08 to 132.97
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 monthsPopulation: Intention-to-Treat population
Diastolic blood pressure measured in mm Hg
Outcome measures
| Measure |
Medically Tailored Meal (MTM)
n=96 Participants
The Medically Tailored Meal (MTM) intervention consists of weekly home meal delivery; an explanation of the medical tailoring of the meals; and a 6-session telephone lifestyle intervention change program designed to complement the period of meal delivery and prepare for the period after meal delivery with behavioral and skill-building approaches to sustain the benefit of the intervention.
|
Food Subsidy
n=98 Participants
As a comparison group, those not randomized to receive the MTM intervention will receive usual care provided by their clinicians not associated with the study, plus a food subsidy ($40/month) for 6 months, along with healthy eating information to guide use of that subsidy.
|
|---|---|---|
|
Diastolic Blood Pressure at Month 6
|
76.22 mm Hg
Interval 73.79 to 78.65
|
79.07 mm Hg
Interval 76.8 to 81.35
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsPopulation: Intention-to-Treat population
Diastolic blood pressure in mm Hg
Outcome measures
| Measure |
Medically Tailored Meal (MTM)
n=96 Participants
The Medically Tailored Meal (MTM) intervention consists of weekly home meal delivery; an explanation of the medical tailoring of the meals; and a 6-session telephone lifestyle intervention change program designed to complement the period of meal delivery and prepare for the period after meal delivery with behavioral and skill-building approaches to sustain the benefit of the intervention.
|
Food Subsidy
n=98 Participants
As a comparison group, those not randomized to receive the MTM intervention will receive usual care provided by their clinicians not associated with the study, plus a food subsidy ($40/month) for 6 months, along with healthy eating information to guide use of that subsidy.
|
|---|---|---|
|
Diastolic Blood Pressure at Month 12
|
77.44 mm Hg
Interval 74.85 to 80.03
|
77.80 mm Hg
Interval 75.49 to 80.11
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 monthsPopulation: Intention-to-Treat population
Diet Quality as assessed by Brief Dietary Assessment Scale. The total score (range 0-50) is reported (higher score indicates better diet quality). The total score is comprised of 3 sections (or subscales) used to assess dietary patterns. The subscales are: Vegetables, Fruit, Whole Grains, and Beans subscale (range 0 - 20), Drinks, Desserts, Snacks, Eating Out, and Salt subscale (range 0- 20), and Fish, Meat, Poultry, Dairy, and Eggs subscale (range 0-10). Total score equals the sum of the 3 subscales.
Outcome measures
| Measure |
Medically Tailored Meal (MTM)
n=96 Participants
The Medically Tailored Meal (MTM) intervention consists of weekly home meal delivery; an explanation of the medical tailoring of the meals; and a 6-session telephone lifestyle intervention change program designed to complement the period of meal delivery and prepare for the period after meal delivery with behavioral and skill-building approaches to sustain the benefit of the intervention.
|
Food Subsidy
n=98 Participants
As a comparison group, those not randomized to receive the MTM intervention will receive usual care provided by their clinicians not associated with the study, plus a food subsidy ($40/month) for 6 months, along with healthy eating information to guide use of that subsidy.
|
|---|---|---|
|
Diet Quality Score at Month 6
|
32.01 Score on a scale
Interval 30.93 to 33.08
|
30.46 Score on a scale
Interval 29.52 to 31.39
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsPopulation: Intention-to-Treat population
Diet Quality as assessed by Brief Dietary Assessment Scale. The total score (range 0-50) is reported (higher score indicates better diet quality). The total score is comprised of 3 sections (or subscales) used to assess dietary patterns. The subscales are: Vegetables, Fruit, Whole Grains, and Beans subscale (range 0 - 20), Drinks, Desserts, Snacks, Eating Out, and Salt subscale (range 0- 20), and Fish, Meat, Poultry, Dairy, and Eggs subscale (range 0-10). Total score equals the sum of the 3 subscales.
Outcome measures
| Measure |
Medically Tailored Meal (MTM)
n=96 Participants
The Medically Tailored Meal (MTM) intervention consists of weekly home meal delivery; an explanation of the medical tailoring of the meals; and a 6-session telephone lifestyle intervention change program designed to complement the period of meal delivery and prepare for the period after meal delivery with behavioral and skill-building approaches to sustain the benefit of the intervention.
|
Food Subsidy
n=98 Participants
As a comparison group, those not randomized to receive the MTM intervention will receive usual care provided by their clinicians not associated with the study, plus a food subsidy ($40/month) for 6 months, along with healthy eating information to guide use of that subsidy.
|
|---|---|---|
|
Diet Quality Score at Month 12
|
30.71 Score on a scale
Interval 29.59 to 31.84
|
29.92 Score on a scale
Interval 28.93 to 30.91
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 monthsPopulation: Intention-to-Treat population
Any affirmative response to one or more of four cost-related medication underuse items derived from the Medical Expenditure Panel Survey. These items ask about not filling a prescription due to cost; skipping medication doses to save money; taking less medication than prescribed to save money; or 4) delaying filling a prescription to save money. Participants with ≥1 affirmative response were classified as having Cost-Related Medication Underuse (CRMU), and the reported values represent the estimated probability of CRMU.
Outcome measures
| Measure |
Medically Tailored Meal (MTM)
n=96 Participants
The Medically Tailored Meal (MTM) intervention consists of weekly home meal delivery; an explanation of the medical tailoring of the meals; and a 6-session telephone lifestyle intervention change program designed to complement the period of meal delivery and prepare for the period after meal delivery with behavioral and skill-building approaches to sustain the benefit of the intervention.
|
Food Subsidy
n=98 Participants
As a comparison group, those not randomized to receive the MTM intervention will receive usual care provided by their clinicians not associated with the study, plus a food subsidy ($40/month) for 6 months, along with healthy eating information to guide use of that subsidy.
|
|---|---|---|
|
Probability of Cost-Related Medication Underuse at Month 6
|
0.19 Probability of CRMU
Interval 0.08 to 0.29
|
0.26 Probability of CRMU
Interval 0.16 to 0.36
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsPopulation: Intention-to-Treat population
Any affirmative response to one or more of four cost-related medication underuse items derived from the Medical Expenditure Panel Survey. These items ask about not filling a prescription due to cost; skipping medication doses to save money; taking less medication than prescribed to save money; or 4) delaying filling a prescription to save money. Participants with ≥1 affirmative response were classified as having Cost-Related Medication Underuse (CRMU), and the reported values represent the estimated probability of CRMU.
Outcome measures
| Measure |
Medically Tailored Meal (MTM)
n=96 Participants
The Medically Tailored Meal (MTM) intervention consists of weekly home meal delivery; an explanation of the medical tailoring of the meals; and a 6-session telephone lifestyle intervention change program designed to complement the period of meal delivery and prepare for the period after meal delivery with behavioral and skill-building approaches to sustain the benefit of the intervention.
|
Food Subsidy
n=98 Participants
As a comparison group, those not randomized to receive the MTM intervention will receive usual care provided by their clinicians not associated with the study, plus a food subsidy ($40/month) for 6 months, along with healthy eating information to guide use of that subsidy.
|
|---|---|---|
|
Probability of Cost-Related Medication Underuse at Month 12
|
0.32 Probability of reporting CRMU
Interval 0.18 to 0.46
|
0.27 Probability of reporting CRMU
Interval 0.16 to 0.38
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 monthsMedication Adherence as assessed by 7-item ARMS-D scale. Scores range from 7 to 28, with higher scores indicating more problems with adherence.
Outcome measures
| Measure |
Medically Tailored Meal (MTM)
n=96 Participants
The Medically Tailored Meal (MTM) intervention consists of weekly home meal delivery; an explanation of the medical tailoring of the meals; and a 6-session telephone lifestyle intervention change program designed to complement the period of meal delivery and prepare for the period after meal delivery with behavioral and skill-building approaches to sustain the benefit of the intervention.
|
Food Subsidy
n=98 Participants
As a comparison group, those not randomized to receive the MTM intervention will receive usual care provided by their clinicians not associated with the study, plus a food subsidy ($40/month) for 6 months, along with healthy eating information to guide use of that subsidy.
|
|---|---|---|
|
ARMS-D (Adherence to Refills and Medications Scale-Diabetes) Medication Adherence Score at Month 6
|
8.91 Scores on a scale
Interval 8.32 to 9.49
|
9.61 Scores on a scale
Interval 9.08 to 10.14
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsPopulation: Intention-to-Treat population
Medication Adherence as assessed by 7-item ARMS-D scale. Scores range from 7 to 28, with higher scores indicating more problems with adherence.
Outcome measures
| Measure |
Medically Tailored Meal (MTM)
n=96 Participants
The Medically Tailored Meal (MTM) intervention consists of weekly home meal delivery; an explanation of the medical tailoring of the meals; and a 6-session telephone lifestyle intervention change program designed to complement the period of meal delivery and prepare for the period after meal delivery with behavioral and skill-building approaches to sustain the benefit of the intervention.
|
Food Subsidy
n=98 Participants
As a comparison group, those not randomized to receive the MTM intervention will receive usual care provided by their clinicians not associated with the study, plus a food subsidy ($40/month) for 6 months, along with healthy eating information to guide use of that subsidy.
|
|---|---|---|
|
ARMS-D Medication Adherence Score at Month 12
|
8.81 Scores on a scale
Interval 8.23 to 9.39
|
9.56 Scores on a scale
Interval 9.02 to 10.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 monthsPopulation: Intention-to-Treat population
Medication Adherence as assessed by 1-item summary of diabetes self-care activities measure. Scores range from 0-7 with higher scores indicating better adherence.
Outcome measures
| Measure |
Medically Tailored Meal (MTM)
n=96 Participants
The Medically Tailored Meal (MTM) intervention consists of weekly home meal delivery; an explanation of the medical tailoring of the meals; and a 6-session telephone lifestyle intervention change program designed to complement the period of meal delivery and prepare for the period after meal delivery with behavioral and skill-building approaches to sustain the benefit of the intervention.
|
Food Subsidy
n=98 Participants
As a comparison group, those not randomized to receive the MTM intervention will receive usual care provided by their clinicians not associated with the study, plus a food subsidy ($40/month) for 6 months, along with healthy eating information to guide use of that subsidy.
|
|---|---|---|
|
Diabetes Self-Care Activities Medication Adherence Score at Month 6
|
6.41 Scores on a scale
Interval 6.0 to 6.82
|
6.10 Scores on a scale
Interval 5.72 to 6.47
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsPopulation: Intention-to-Treat population
Medication Adherence as assessed by 1-item summary of diabetes self-care activities measure. Scores range from 0-7 with higher scores indicating better adherence.
Outcome measures
| Measure |
Medically Tailored Meal (MTM)
n=96 Participants
The Medically Tailored Meal (MTM) intervention consists of weekly home meal delivery; an explanation of the medical tailoring of the meals; and a 6-session telephone lifestyle intervention change program designed to complement the period of meal delivery and prepare for the period after meal delivery with behavioral and skill-building approaches to sustain the benefit of the intervention.
|
Food Subsidy
n=98 Participants
As a comparison group, those not randomized to receive the MTM intervention will receive usual care provided by their clinicians not associated with the study, plus a food subsidy ($40/month) for 6 months, along with healthy eating information to guide use of that subsidy.
|
|---|---|---|
|
Diabetes Self-Care Activities Medication Adherence Score at Month 12
|
6.01 Scores on a scale
Interval 5.52 to 6.51
|
6.28 Scores on a scale
Interval 5.87 to 6.68
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 monthsPopulation: Intention-to-Treat population
Single item-indicators of trading off medication for food or food for medication. An affirmative response indicates the presence of a trade-off.
Outcome measures
| Measure |
Medically Tailored Meal (MTM)
n=96 Participants
The Medically Tailored Meal (MTM) intervention consists of weekly home meal delivery; an explanation of the medical tailoring of the meals; and a 6-session telephone lifestyle intervention change program designed to complement the period of meal delivery and prepare for the period after meal delivery with behavioral and skill-building approaches to sustain the benefit of the intervention.
|
Food Subsidy
n=98 Participants
As a comparison group, those not randomized to receive the MTM intervention will receive usual care provided by their clinicians not associated with the study, plus a food subsidy ($40/month) for 6 months, along with healthy eating information to guide use of that subsidy.
|
|---|---|---|
|
Food/Medication Trade-offs at Month 6
Often
|
0 Participants
|
3 Participants
|
|
Food/Medication Trade-offs at Month 6
Sometimes
|
3 Participants
|
13 Participants
|
|
Food/Medication Trade-offs at Month 6
Rarely
|
6 Participants
|
5 Participants
|
|
Food/Medication Trade-offs at Month 6
Never
|
50 Participants
|
67 Participants
|
|
Food/Medication Trade-offs at Month 6
Missing
|
37 Participants
|
10 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsSingle item-indicators of trading off medication for food or food for medication. An affirmative response indicates the presence of a trade-off.
Outcome measures
| Measure |
Medically Tailored Meal (MTM)
n=96 Participants
The Medically Tailored Meal (MTM) intervention consists of weekly home meal delivery; an explanation of the medical tailoring of the meals; and a 6-session telephone lifestyle intervention change program designed to complement the period of meal delivery and prepare for the period after meal delivery with behavioral and skill-building approaches to sustain the benefit of the intervention.
|
Food Subsidy
n=98 Participants
As a comparison group, those not randomized to receive the MTM intervention will receive usual care provided by their clinicians not associated with the study, plus a food subsidy ($40/month) for 6 months, along with healthy eating information to guide use of that subsidy.
|
|---|---|---|
|
Food/Medication Trade-offs at Month 12
Missing
|
40 Participants
|
17 Participants
|
|
Food/Medication Trade-offs at Month 12
Rarely
|
7 Participants
|
5 Participants
|
|
Food/Medication Trade-offs at Month 12
Never
|
41 Participants
|
69 Participants
|
|
Food/Medication Trade-offs at Month 12
Often
|
1 Participants
|
4 Participants
|
|
Food/Medication Trade-offs at Month 12
Sometimes
|
7 Participants
|
3 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 monthsPopulation: Intention-to-Treat population
Self-report of being worried about losing housing
Outcome measures
| Measure |
Medically Tailored Meal (MTM)
n=96 Participants
The Medically Tailored Meal (MTM) intervention consists of weekly home meal delivery; an explanation of the medical tailoring of the meals; and a 6-session telephone lifestyle intervention change program designed to complement the period of meal delivery and prepare for the period after meal delivery with behavioral and skill-building approaches to sustain the benefit of the intervention.
|
Food Subsidy
n=98 Participants
As a comparison group, those not randomized to receive the MTM intervention will receive usual care provided by their clinicians not associated with the study, plus a food subsidy ($40/month) for 6 months, along with healthy eating information to guide use of that subsidy.
|
|---|---|---|
|
Housing Insecurity at Month 6
|
0.30 probability of reporting concern
Interval 0.17 to 0.44
|
0.30 probability of reporting concern
Interval 0.2 to 0.41
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsPopulation: Intention-to-Treat population
Self-report of being worried about losing housing
Outcome measures
| Measure |
Medically Tailored Meal (MTM)
n=96 Participants
The Medically Tailored Meal (MTM) intervention consists of weekly home meal delivery; an explanation of the medical tailoring of the meals; and a 6-session telephone lifestyle intervention change program designed to complement the period of meal delivery and prepare for the period after meal delivery with behavioral and skill-building approaches to sustain the benefit of the intervention.
|
Food Subsidy
n=98 Participants
As a comparison group, those not randomized to receive the MTM intervention will receive usual care provided by their clinicians not associated with the study, plus a food subsidy ($40/month) for 6 months, along with healthy eating information to guide use of that subsidy.
|
|---|---|---|
|
Housing Insecurity Score at Month 12
|
0.24 Probability of reporting concern
Interval 0.12 to 0.37
|
0.31 Probability of reporting concern
Interval 0.2 to 0.42
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 monthsPopulation: Intention-to-Treat population
Self-report of transportation barriers to attending medical appointments
Outcome measures
| Measure |
Medically Tailored Meal (MTM)
n=96 Participants
The Medically Tailored Meal (MTM) intervention consists of weekly home meal delivery; an explanation of the medical tailoring of the meals; and a 6-session telephone lifestyle intervention change program designed to complement the period of meal delivery and prepare for the period after meal delivery with behavioral and skill-building approaches to sustain the benefit of the intervention.
|
Food Subsidy
n=98 Participants
As a comparison group, those not randomized to receive the MTM intervention will receive usual care provided by their clinicians not associated with the study, plus a food subsidy ($40/month) for 6 months, along with healthy eating information to guide use of that subsidy.
|
|---|---|---|
|
Transportation Barriers at Month 6
|
0.18 Probability of reporting concern
Interval 0.07 to 0.29
|
0.20 Probability of reporting concern
Interval 0.1 to 0.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsPopulation: Intention-to-Treat population
Self-report of transportation barriers to attending medical appointments
Outcome measures
| Measure |
Medically Tailored Meal (MTM)
n=96 Participants
The Medically Tailored Meal (MTM) intervention consists of weekly home meal delivery; an explanation of the medical tailoring of the meals; and a 6-session telephone lifestyle intervention change program designed to complement the period of meal delivery and prepare for the period after meal delivery with behavioral and skill-building approaches to sustain the benefit of the intervention.
|
Food Subsidy
n=98 Participants
As a comparison group, those not randomized to receive the MTM intervention will receive usual care provided by their clinicians not associated with the study, plus a food subsidy ($40/month) for 6 months, along with healthy eating information to guide use of that subsidy.
|
|---|---|---|
|
Transportation Barriers at Month 12
|
0.17 Probability of reporting concern
Interval 0.06 to 0.28
|
0.21 Probability of reporting concern
Interval 0.11 to 0.32
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 monthsPopulation: Intention-to-Treat population
Self-report of financial strain
Outcome measures
| Measure |
Medically Tailored Meal (MTM)
n=96 Participants
The Medically Tailored Meal (MTM) intervention consists of weekly home meal delivery; an explanation of the medical tailoring of the meals; and a 6-session telephone lifestyle intervention change program designed to complement the period of meal delivery and prepare for the period after meal delivery with behavioral and skill-building approaches to sustain the benefit of the intervention.
|
Food Subsidy
n=98 Participants
As a comparison group, those not randomized to receive the MTM intervention will receive usual care provided by their clinicians not associated with the study, plus a food subsidy ($40/month) for 6 months, along with healthy eating information to guide use of that subsidy.
|
|---|---|---|
|
Financial Strain
Often
|
0.18 Probability of reporting response
Standard Error 0.01
|
0.18 Probability of reporting response
Standard Error 0.02
|
|
Financial Strain
Always
|
0.20 Probability of reporting response
Standard Error 0.04
|
0.20 Probability of reporting response
Standard Error 0.03
|
|
Financial Strain
Never
|
0.14 Probability of reporting response
Standard Error 0.03
|
0.14 Probability of reporting response
Standard Error 0.02
|
|
Financial Strain
Rarely
|
0.13 Probability of reporting response
Standard Error 0.01
|
0.13 Probability of reporting response
Standard Error 0.01
|
|
Financial Strain
Sometimes
|
0.34 Probability of reporting response
Standard Error 0.02
|
0.35 Probability of reporting response
Standard Error 0.01
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsPopulation: Intention-to-Treat population
Self-report of financial strain
Outcome measures
| Measure |
Medically Tailored Meal (MTM)
n=96 Participants
The Medically Tailored Meal (MTM) intervention consists of weekly home meal delivery; an explanation of the medical tailoring of the meals; and a 6-session telephone lifestyle intervention change program designed to complement the period of meal delivery and prepare for the period after meal delivery with behavioral and skill-building approaches to sustain the benefit of the intervention.
|
Food Subsidy
n=98 Participants
As a comparison group, those not randomized to receive the MTM intervention will receive usual care provided by their clinicians not associated with the study, plus a food subsidy ($40/month) for 6 months, along with healthy eating information to guide use of that subsidy.
|
|---|---|---|
|
Financial Strain
Sometimes
|
0.35 Probability of response
Standard Error 0.02
|
0.35 Probability of response
Standard Error 0.01
|
|
Financial Strain
Often
|
0.18 Probability of response
Standard Error 0.02
|
0.17 Probability of response
Standard Error 0.01
|
|
Financial Strain
Always
|
0.19 Probability of response
Standard Error 0.03
|
0.16 Probability of response
Standard Error 0.03
|
|
Financial Strain
Never
|
0.15 Probability of response
Standard Error 0.03
|
0.17 Probability of response
Standard Error 0.03
|
|
Financial Strain
Rarely
|
0.13 Probability of response
Standard Error 0.01
|
0.14 Probability of response
Standard Error 0.01
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 monthsSelf-report of delaying healthcare due to cost
Outcome measures
| Measure |
Medically Tailored Meal (MTM)
n=96 Participants
The Medically Tailored Meal (MTM) intervention consists of weekly home meal delivery; an explanation of the medical tailoring of the meals; and a 6-session telephone lifestyle intervention change program designed to complement the period of meal delivery and prepare for the period after meal delivery with behavioral and skill-building approaches to sustain the benefit of the intervention.
|
Food Subsidy
n=98 Participants
As a comparison group, those not randomized to receive the MTM intervention will receive usual care provided by their clinicians not associated with the study, plus a food subsidy ($40/month) for 6 months, along with healthy eating information to guide use of that subsidy.
|
|---|---|---|
|
Care Delay at Month 6
|
0.05 Probability of reporting delay
Interval -0.01 to 0.12
|
0.14 Probability of reporting delay
Interval 0.05 to 0.23
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsPopulation: Intention-to-Treat population
Self-report of delaying healthcare due to cost
Outcome measures
| Measure |
Medically Tailored Meal (MTM)
n=96 Participants
The Medically Tailored Meal (MTM) intervention consists of weekly home meal delivery; an explanation of the medical tailoring of the meals; and a 6-session telephone lifestyle intervention change program designed to complement the period of meal delivery and prepare for the period after meal delivery with behavioral and skill-building approaches to sustain the benefit of the intervention.
|
Food Subsidy
n=98 Participants
As a comparison group, those not randomized to receive the MTM intervention will receive usual care provided by their clinicians not associated with the study, plus a food subsidy ($40/month) for 6 months, along with healthy eating information to guide use of that subsidy.
|
|---|---|---|
|
Care Delay at Month 12
|
0.10 Probability of reporting delay
Interval 0.01 to 0.19
|
0.12 Probability of reporting delay
Interval 0.04 to 0.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 monthsPopulation: Intention-to-Treat population
Diet Self-Efficacy as assessed by cardiac diet self-efficacy scale. Scores range from 16 to 80 with higher scores indicating greater self-efficacy.
Outcome measures
| Measure |
Medically Tailored Meal (MTM)
n=96 Participants
The Medically Tailored Meal (MTM) intervention consists of weekly home meal delivery; an explanation of the medical tailoring of the meals; and a 6-session telephone lifestyle intervention change program designed to complement the period of meal delivery and prepare for the period after meal delivery with behavioral and skill-building approaches to sustain the benefit of the intervention.
|
Food Subsidy
n=98 Participants
As a comparison group, those not randomized to receive the MTM intervention will receive usual care provided by their clinicians not associated with the study, plus a food subsidy ($40/month) for 6 months, along with healthy eating information to guide use of that subsidy.
|
|---|---|---|
|
Diet Self-Efficacy Score at Month 6
|
64.35 Scores on a scale
Interval 61.26 to 67.44
|
58.15 Scores on a scale
Interval 55.57 to 60.73
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsPopulation: Intention-to-Treat population
Diet Self-Efficacy as assessed by cardiac diet self-efficacy scale. Scores range from 16 to 80 with higher scores indicating greater self-efficacy.
Outcome measures
| Measure |
Medically Tailored Meal (MTM)
n=96 Participants
The Medically Tailored Meal (MTM) intervention consists of weekly home meal delivery; an explanation of the medical tailoring of the meals; and a 6-session telephone lifestyle intervention change program designed to complement the period of meal delivery and prepare for the period after meal delivery with behavioral and skill-building approaches to sustain the benefit of the intervention.
|
Food Subsidy
n=98 Participants
As a comparison group, those not randomized to receive the MTM intervention will receive usual care provided by their clinicians not associated with the study, plus a food subsidy ($40/month) for 6 months, along with healthy eating information to guide use of that subsidy.
|
|---|---|---|
|
Diet Self-Efficacy Score at Month 12
|
59.22 Scores on a scale
Interval 56.37 to 62.07
|
58.12 Scores on a scale
Interval 55.47 to 60.76
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 monthsPopulation: Intention-to-Treat population
Diabetes Self-Efficacy as assessed by Perceived Diabetes Self-Management Scale. Scores range from 8 to 40 with higher scores indicating greater self-efficacy
Outcome measures
| Measure |
Medically Tailored Meal (MTM)
n=96 Participants
The Medically Tailored Meal (MTM) intervention consists of weekly home meal delivery; an explanation of the medical tailoring of the meals; and a 6-session telephone lifestyle intervention change program designed to complement the period of meal delivery and prepare for the period after meal delivery with behavioral and skill-building approaches to sustain the benefit of the intervention.
|
Food Subsidy
n=98 Participants
As a comparison group, those not randomized to receive the MTM intervention will receive usual care provided by their clinicians not associated with the study, plus a food subsidy ($40/month) for 6 months, along with healthy eating information to guide use of that subsidy.
|
|---|---|---|
|
Perceived Diabetes Self-Management Self-Efficacy Score at Month 6
|
31.90 Scores on a scale
Interval 30.15 to 33.65
|
27.75 Scores on a scale
Interval 26.32 to 29.18
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsPopulation: Intention-to-Treat population
Diabetes Self-Efficacy as assessed by Perceived Diabetes Self-Management Scale. Scores range from 8 to 40 with higher scores indicating greater self-efficacy
Outcome measures
| Measure |
Medically Tailored Meal (MTM)
n=96 Participants
The Medically Tailored Meal (MTM) intervention consists of weekly home meal delivery; an explanation of the medical tailoring of the meals; and a 6-session telephone lifestyle intervention change program designed to complement the period of meal delivery and prepare for the period after meal delivery with behavioral and skill-building approaches to sustain the benefit of the intervention.
|
Food Subsidy
n=98 Participants
As a comparison group, those not randomized to receive the MTM intervention will receive usual care provided by their clinicians not associated with the study, plus a food subsidy ($40/month) for 6 months, along with healthy eating information to guide use of that subsidy.
|
|---|---|---|
|
Perceived Diabetes Self-Management Self-Efficacy Score at Month 12
|
29.82 Scores on a scale
Interval 28.05 to 31.58
|
28.13 Scores on a scale
Interval 26.65 to 29.62
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 monthsPopulation: Intention-to-Treat population
Stress as assessed by perceived stress scale. Scores range from 0 to 40 with higher scores indicating higher perceived stress.
Outcome measures
| Measure |
Medically Tailored Meal (MTM)
n=96 Participants
The Medically Tailored Meal (MTM) intervention consists of weekly home meal delivery; an explanation of the medical tailoring of the meals; and a 6-session telephone lifestyle intervention change program designed to complement the period of meal delivery and prepare for the period after meal delivery with behavioral and skill-building approaches to sustain the benefit of the intervention.
|
Food Subsidy
n=98 Participants
As a comparison group, those not randomized to receive the MTM intervention will receive usual care provided by their clinicians not associated with the study, plus a food subsidy ($40/month) for 6 months, along with healthy eating information to guide use of that subsidy.
|
|---|---|---|
|
Stress Score at 6 Months
|
21.53 Scores on a scale
Interval 20.11 to 22.94
|
19.55 Scores on a scale
Interval 18.4 to 20.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsPopulation: Intention-to-Treat population
Stress as assessed by perceived stress scale. Scores range from 0 to 40 with higher scores indicating higher perceived stress.
Outcome measures
| Measure |
Medically Tailored Meal (MTM)
n=96 Participants
The Medically Tailored Meal (MTM) intervention consists of weekly home meal delivery; an explanation of the medical tailoring of the meals; and a 6-session telephone lifestyle intervention change program designed to complement the period of meal delivery and prepare for the period after meal delivery with behavioral and skill-building approaches to sustain the benefit of the intervention.
|
Food Subsidy
n=98 Participants
As a comparison group, those not randomized to receive the MTM intervention will receive usual care provided by their clinicians not associated with the study, plus a food subsidy ($40/month) for 6 months, along with healthy eating information to guide use of that subsidy.
|
|---|---|---|
|
Stress Score at 12 Months
|
21.89 Scores on a scale
Interval 20.48 to 23.3
|
20.70 Scores on a scale
Interval 19.52 to 21.87
|
Adverse Events
Medically Tailored Meal (MTM)
Serious events: 13 serious events
Other events: 3 other events
Deaths: 0 deaths
Food Subsidy
Serious events: 8 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Medically Tailored Meal (MTM)
n=96 participants at risk
The Medically Tailored Meal (MTM) intervention consists of weekly home meal delivery; an explanation of the medical tailoring of the meals; and a 6-session telephone lifestyle intervention change program designed to complement the period of meal delivery and prepare for the period after meal delivery with behavioral and skill-building approaches to sustain the benefit of the intervention.
|
Food Subsidy
n=98 participants at risk
As a comparison group, those not randomized to receive the MTM intervention will receive usual care provided by their clinicians not associated with the study, plus a food subsidy ($40/month) for 6 months, along with healthy eating information to guide use of that subsidy.
|
|---|---|---|
|
Infections and infestations
MRSA infection
|
1.0%
1/96 • From randomization until end of follow-up, 12 months
|
0.00%
0/98 • From randomization until end of follow-up, 12 months
|
|
Infections and infestations
Foot Wound
|
3.1%
3/96 • From randomization until end of follow-up, 12 months
|
1.0%
1/98 • From randomization until end of follow-up, 12 months
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/96 • From randomization until end of follow-up, 12 months
|
1.0%
1/98 • From randomization until end of follow-up, 12 months
|
|
Nervous system disorders
White Matter Disease
|
0.00%
0/96 • From randomization until end of follow-up, 12 months
|
1.0%
1/98 • From randomization until end of follow-up, 12 months
|
|
Psychiatric disorders
Psychiatric Hospitalization
|
4.2%
4/96 • From randomization until end of follow-up, 12 months
|
1.0%
1/98 • From randomization until end of follow-up, 12 months
|
|
Infections and infestations
Respiratory Infection
|
1.0%
1/96 • From randomization until end of follow-up, 12 months
|
1.0%
1/98 • From randomization until end of follow-up, 12 months
|
|
Renal and urinary disorders
Dehydration
|
0.00%
0/96 • From randomization until end of follow-up, 12 months
|
1.0%
1/98 • From randomization until end of follow-up, 12 months
|
|
Eye disorders
Vitrectomy
|
0.00%
0/96 • From randomization until end of follow-up, 12 months
|
1.0%
1/98 • From randomization until end of follow-up, 12 months
|
|
Endocrine disorders
Hyperglycemia
|
0.00%
0/96 • From randomization until end of follow-up, 12 months
|
1.0%
1/98 • From randomization until end of follow-up, 12 months
|
|
General disorders
Fall
|
1.0%
1/96 • From randomization until end of follow-up, 12 months
|
0.00%
0/98 • From randomization until end of follow-up, 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer
|
1.0%
1/96 • From randomization until end of follow-up, 12 months
|
0.00%
0/98 • From randomization until end of follow-up, 12 months
|
|
Cardiac disorders
CHF Exacerbation
|
1.0%
1/96 • From randomization until end of follow-up, 12 months
|
0.00%
0/98 • From randomization until end of follow-up, 12 months
|
|
Musculoskeletal and connective tissue disorders
Back Spasms
|
1.0%
1/96 • From randomization until end of follow-up, 12 months
|
0.00%
0/98 • From randomization until end of follow-up, 12 months
|
Other adverse events
| Measure |
Medically Tailored Meal (MTM)
n=96 participants at risk
The Medically Tailored Meal (MTM) intervention consists of weekly home meal delivery; an explanation of the medical tailoring of the meals; and a 6-session telephone lifestyle intervention change program designed to complement the period of meal delivery and prepare for the period after meal delivery with behavioral and skill-building approaches to sustain the benefit of the intervention.
|
Food Subsidy
n=98 participants at risk
As a comparison group, those not randomized to receive the MTM intervention will receive usual care provided by their clinicians not associated with the study, plus a food subsidy ($40/month) for 6 months, along with healthy eating information to guide use of that subsidy.
|
|---|---|---|
|
Endocrine disorders
Hyperglycemia
|
3.1%
3/96 • Number of events 3 • From randomization until end of follow-up, 12 months
|
2.0%
2/98 • Number of events 2 • From randomization until end of follow-up, 12 months
|
Additional Information
Katarine Ricks, PhD
University of North Carolina at Chapel Hill
Phone: 919-966-0062
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place