Trial Outcomes & Findings for Home Food Delivery for Diabetes Management in Patients of Rural Clinics (NCT NCT04876053)
NCT ID: NCT04876053
Last Updated: 2026-08-21
Results Overview
Finger stick blood collection will be used to test HbA1c using a Siemens DCA Vantage analyzer.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
416 participants
Primary outcome timeframe
Baseline; Immediate post-intervention; 6 months post-intervention; 12 months post-intervention
Results posted on
2026-08-21
Participant Flow
Participant milestones
| Measure |
CDCES Consultation Only
Participants randomized to this study arm receive the standard of care at the clinic from which they were recruited, plus a 60 minute healthy eating consultation with a Certified Diabetes Care and Education Specialist and a food pantry resource guide specific to their community.
CDCES Consultation Only: Participants randomized to this study arm receive the standard of care at the clinic from which they were recruited, plus a 60 minute healthy eating consultation with a Certified Diabetes Care and Education Specialist and a food pantry resource guide specific to their community.
|
Healthy Food Delivery Intervention
In addition to standard of care and the CDCES consultation, participants randomized to the Healthy Food Delivery arm receive weekly home delivery of type 2 diabetes-appropriate food boxes over 3 months (12 food boxes in total).
Healthy Food Delivery Intervention: Participants randomized to the Healthy Food Delivery Intervention receive standard of care, a CDCES Consultation, food pantry resource guide, and weekly home delivery of type 2 diabetes-appropriate food boxes over 3 months (12 food boxes in total).Each food box included approximately 9000 calories of food. Food boxes were designed by a Registered Dietician. Food boxes also included recipes and cooking tips specific to foods included in that week's box.
|
|---|---|---|
|
Baseline (Pre-intervention)
STARTED
|
211
|
205
|
|
Baseline (Pre-intervention)
COMPLETED
|
211
|
205
|
|
Baseline (Pre-intervention)
NOT COMPLETED
|
0
|
0
|
|
Immediate Post-intervention
STARTED
|
211
|
205
|
|
Immediate Post-intervention
COMPLETED
|
164
|
170
|
|
Immediate Post-intervention
NOT COMPLETED
|
47
|
35
|
|
6 Months Post-Intervention
STARTED
|
211
|
205
|
|
6 Months Post-Intervention
COMPLETED
|
147
|
149
|
|
6 Months Post-Intervention
NOT COMPLETED
|
64
|
56
|
|
12 Months Post-Intervention
STARTED
|
211
|
205
|
|
12 Months Post-Intervention
COMPLETED
|
132
|
131
|
|
12 Months Post-Intervention
NOT COMPLETED
|
79
|
74
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Home Food Delivery for Diabetes Management in Patients of Rural Clinics
Baseline characteristics by cohort
| Measure |
CDCES Consultation Only
n=211 Participants
Participants randomized to this study arm receive the standard of care at the clinic from which they were recruited, plus a 60 minute healthy eating consultation with a Certified Diabetes Care and Education Specialist and a food pantry resource guide specific to their community.
CDCES Consultation Only: Participants randomized to this study arm receive the standard of care at the clinic from which they were recruited, plus a 60 minute healthy eating consultation with a Certified Diabetes Care and Education Specialist and a food pantry resource guide specific to their community.
|
Healthy Food Delivery Intervention
n=205 Participants
In addition to standard of care and the CDCES consultation, participants randomized to the Healthy Food Delivery arm receive weekly home delivery of type 2 diabetes-appropriate food boxes over 3 months (12 food boxes in total).
Healthy Food Delivery Intervention: Participants randomized to the Healthy Food Delivery Intervention receive standard of care, a CDCES Consultation, food pantry resource guide, and weekly home delivery of type 2 diabetes-appropriate food boxes over 3 months (12 food boxes in total).Each food box included approximately 9000 calories of food. Food boxes were designed by a Registered Dietician. Food boxes also included recipes and cooking tips specific to foods included in that week's box.
|
Total
n=416 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.06 years
STANDARD_DEVIATION 12.34 • n=5 Participants
|
58.87 years
STANDARD_DEVIATION 12.40 • n=109 Participants
|
59.47 years
STANDARD_DEVIATION 12.37 • n=133 Participants
|
|
Sex: Female, Male
Female
|
140 Participants
n=5 Participants
|
140 Participants
n=109 Participants
|
280 Participants
n=133 Participants
|
|
Sex: Female, Male
Male
|
71 Participants
n=5 Participants
|
65 Participants
n=109 Participants
|
136 Participants
n=133 Participants
|
|
Race/Ethnicity, Customized
White
|
126 Participants
n=5 Participants
|
119 Participants
n=109 Participants
|
245 Participants
n=133 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
68 Participants
n=5 Participants
|
73 Participants
n=109 Participants
|
141 Participants
n=133 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
3 Participants
n=109 Participants
|
5 Participants
n=133 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 Participants
n=5 Participants
|
2 Participants
n=109 Participants
|
5 Participants
n=133 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
8 Participants
n=5 Participants
|
8 Participants
n=109 Participants
|
16 Participants
n=133 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 Participants
n=5 Participants
|
0 Participants
n=109 Participants
|
3 Participants
n=133 Participants
|
|
Race/Ethnicity, Customized
Refused/Missing
|
1 Participants
n=5 Participants
|
0 Participants
n=109 Participants
|
1 Participants
n=133 Participants
|
|
Region of Enrollment
United States
|
211 participants
n=5 Participants
|
205 participants
n=109 Participants
|
416 participants
n=133 Participants
|
|
Hemoglobin A1c (HbA1c), %
|
8.34 % (percentage of glycated hemoglobin)
STANDARD_DEVIATION 1.69 • n=5 Participants
|
8.41 % (percentage of glycated hemoglobin)
STANDARD_DEVIATION 1.87 • n=109 Participants
|
8.37 % (percentage of glycated hemoglobin)
STANDARD_DEVIATION 1.78 • n=133 Participants
|
PRIMARY outcome
Timeframe: Baseline; Immediate post-intervention; 6 months post-intervention; 12 months post-interventionPopulation: This study adopted an intent-to-treat approach such that data from all randomly assigned participants (N=416) were included in analyses. To address missing data, we used the random forest method in multiple imputation by chained equations (MICE; m=50).
Finger stick blood collection will be used to test HbA1c using a Siemens DCA Vantage analyzer.
Outcome measures
| Measure |
CDCES Consultation Only
n=211 Participants
Participants randomized to this study arm receive the standard of care at the clinic from which they were recruited, plus a 60 minute healthy eating consultation with a Certified Diabetes Care and Education Specialist and a food pantry resource guide specific to their community.
CDCES Consultation Only: Participants randomized to this study arm receive the standard of care at the clinic from which they were recruited, plus a 60 minute healthy eating consultation with a Certified Diabetes Care and Education Specialist and a food pantry resource guide specific to their community.
|
Healthy Food Delivery Intervention
n=205 Participants
In addition to standard of care and the CDCES consultation, participants randomized to the Healthy Food Delivery arm receive weekly home delivery of type 2 diabetes-appropriate food boxes over 3 months (12 food boxes in total).
Healthy Food Delivery Intervention: Participants randomized to the Healthy Food Delivery Intervention receive standard of care, a CDCES Consultation, food pantry resource guide, and weekly home delivery of type 2 diabetes-appropriate food boxes over 3 months (12 food boxes in total).Each food box included approximately 9000 calories of food. Food boxes were designed by a Registered Dietician. Food boxes also included recipes and cooking tips specific to foods included in that week's box.
|
|---|---|---|
|
Hemoglobin A1c (HbA1c)
Baseline
|
8.30 % (percentage of glycated hemoglobin)
Interval 7.78 to 8.83
|
8.34 % (percentage of glycated hemoglobin)
Interval 7.8 to 8.88
|
|
Hemoglobin A1c (HbA1c)
Immediate post-intervention
|
7.92 % (percentage of glycated hemoglobin)
Interval 7.36 to 8.47
|
7.81 % (percentage of glycated hemoglobin)
Interval 7.26 to 8.35
|
|
Hemoglobin A1c (HbA1c)
6 Months post-intervention
|
7.93 % (percentage of glycated hemoglobin)
Interval 7.36 to 8.5
|
7.97 % (percentage of glycated hemoglobin)
Interval 7.41 to 8.53
|
|
Hemoglobin A1c (HbA1c)
12 Months post-intervention
|
7.69 % (percentage of glycated hemoglobin)
Interval 7.13 to 8.24
|
7.69 % (percentage of glycated hemoglobin)
Interval 7.11 to 8.27
|
SECONDARY outcome
Timeframe: Baseline; Immediate post-interventionPopulation: Unlike other outcomes in this study, the Healthy Eating Index outcome analysis was limited to only participants with valid baseline or post-intervention dietary recalls (N=356). HEI outcomes at 6 months post-intervention and 12 months post-intervention were not assessed. To address missing data among those with valid baseline or post-intervention dietary recalls, we used the random forest method in multiple imputation by chained equations (MICE; m=50).
Diet quality was assessed with a 24-hour dietary recall interview using the Nutrition Data System for Research (NDSR) software. The Healthy Eating Index-2015 (HEI) was applied to the dietary recall data to measure the extent that dietary intake among participants met the Dietary Guidelines for Americans 2015-2020 recommendations. HEI-2015 consists of 13 individual components. HEI-2015 scores have a possible range of 0-100, with higher numbers indicating better diet quality.
Outcome measures
| Measure |
CDCES Consultation Only
n=178 Participants
Participants randomized to this study arm receive the standard of care at the clinic from which they were recruited, plus a 60 minute healthy eating consultation with a Certified Diabetes Care and Education Specialist and a food pantry resource guide specific to their community.
CDCES Consultation Only: Participants randomized to this study arm receive the standard of care at the clinic from which they were recruited, plus a 60 minute healthy eating consultation with a Certified Diabetes Care and Education Specialist and a food pantry resource guide specific to their community.
|
Healthy Food Delivery Intervention
n=178 Participants
In addition to standard of care and the CDCES consultation, participants randomized to the Healthy Food Delivery arm receive weekly home delivery of type 2 diabetes-appropriate food boxes over 3 months (12 food boxes in total).
Healthy Food Delivery Intervention: Participants randomized to the Healthy Food Delivery Intervention receive standard of care, a CDCES Consultation, food pantry resource guide, and weekly home delivery of type 2 diabetes-appropriate food boxes over 3 months (12 food boxes in total).Each food box included approximately 9000 calories of food. Food boxes were designed by a Registered Dietician. Food boxes also included recipes and cooking tips specific to foods included in that week's box.
|
|---|---|---|
|
Diet Quality: Healthy Eating Index-2015 Score
Baseline
|
51.76 Healthy Eating Index-2015 scores
Interval 47.51 to 56.01
|
51.82 Healthy Eating Index-2015 scores
Interval 47.46 to 56.17
|
|
Diet Quality: Healthy Eating Index-2015 Score
Immediate post-intervention
|
51.65 Healthy Eating Index-2015 scores
Interval 47.26 to 56.04
|
54.58 Healthy Eating Index-2015 scores
Interval 49.97 to 59.18
|
SECONDARY outcome
Timeframe: Baseline; Immediate post-intervention; 6 months post-intervention; 12 months post-interventionPopulation: This study adopted an intent-to-treat approach such that data from all randomly assigned participants (N=416) were included in analyses. To address missing data, we used the random forest method in multiple imputation by chained equations (MICE; m=50).
Skin carotenoid level was measured using a Veggie Meter optical skin scanner, which uses Raman Spectroscopy. The Veggie Meter assesses frequency changes in reflected light to calculate carotenoid presence in the skin and has been validated as a non-self-report, non-invasive measure associated with serum carotenoid levels and self-report measures of fruit and vegetable consumption. Each participant's index finger was scanned three times and the mean of the three measures was recorded for use in data analysis. Veggie Meter scores have a possible range of 0-800, with higher scores indicating better diet quality.
Outcome measures
| Measure |
CDCES Consultation Only
n=211 Participants
Participants randomized to this study arm receive the standard of care at the clinic from which they were recruited, plus a 60 minute healthy eating consultation with a Certified Diabetes Care and Education Specialist and a food pantry resource guide specific to their community.
CDCES Consultation Only: Participants randomized to this study arm receive the standard of care at the clinic from which they were recruited, plus a 60 minute healthy eating consultation with a Certified Diabetes Care and Education Specialist and a food pantry resource guide specific to their community.
|
Healthy Food Delivery Intervention
n=205 Participants
In addition to standard of care and the CDCES consultation, participants randomized to the Healthy Food Delivery arm receive weekly home delivery of type 2 diabetes-appropriate food boxes over 3 months (12 food boxes in total).
Healthy Food Delivery Intervention: Participants randomized to the Healthy Food Delivery Intervention receive standard of care, a CDCES Consultation, food pantry resource guide, and weekly home delivery of type 2 diabetes-appropriate food boxes over 3 months (12 food boxes in total).Each food box included approximately 9000 calories of food. Food boxes were designed by a Registered Dietician. Food boxes also included recipes and cooking tips specific to foods included in that week's box.
|
|---|---|---|
|
Diet Quality: Veggie Meter Score
Baseline
|
244.70 Veggie Meter scores
Interval 211.24 to 278.15
|
240.42 Veggie Meter scores
Interval 206.74 to 274.09
|
|
Diet Quality: Veggie Meter Score
Immediate post-intervention
|
252.61 Veggie Meter scores
Interval 216.25 to 288.96
|
259.46 Veggie Meter scores
Interval 224.27 to 294.65
|
|
Diet Quality: Veggie Meter Score
6 Months post-intervention
|
260.96 Veggie Meter scores
Interval 226.44 to 295.49
|
259.21 Veggie Meter scores
Interval 224.03 to 294.38
|
|
Diet Quality: Veggie Meter Score
12 Months post-intervention
|
239.20 Veggie Meter scores
Interval 204.15 to 274.26
|
246.83 Veggie Meter scores
Interval 212.04 to 281.61
|
SECONDARY outcome
Timeframe: Baseline; Immediate post-intervention; 6 months post-intervention; 12 months post-interventionPopulation: This study adopted an intent-to-treat approach such that data from all randomly assigned participants (N=416) were included in analyses. To address missing data, we used the random forest method in multiple imputation by chained equations (MICE; m=50).
Participant height (without shoes) was collected using a stadiometer and participant weight (without shoes) was collected using a calibrated digital scale. Height and weight were used to compute a continuous measure of BMI (kilograms per square meter).
Outcome measures
| Measure |
CDCES Consultation Only
n=211 Participants
Participants randomized to this study arm receive the standard of care at the clinic from which they were recruited, plus a 60 minute healthy eating consultation with a Certified Diabetes Care and Education Specialist and a food pantry resource guide specific to their community.
CDCES Consultation Only: Participants randomized to this study arm receive the standard of care at the clinic from which they were recruited, plus a 60 minute healthy eating consultation with a Certified Diabetes Care and Education Specialist and a food pantry resource guide specific to their community.
|
Healthy Food Delivery Intervention
n=205 Participants
In addition to standard of care and the CDCES consultation, participants randomized to the Healthy Food Delivery arm receive weekly home delivery of type 2 diabetes-appropriate food boxes over 3 months (12 food boxes in total).
Healthy Food Delivery Intervention: Participants randomized to the Healthy Food Delivery Intervention receive standard of care, a CDCES Consultation, food pantry resource guide, and weekly home delivery of type 2 diabetes-appropriate food boxes over 3 months (12 food boxes in total).Each food box included approximately 9000 calories of food. Food boxes were designed by a Registered Dietician. Food boxes also included recipes and cooking tips specific to foods included in that week's box.
|
|---|---|---|
|
Body Mass Index (BMI)
6 months post-intervention
|
33.14 kg/m²
Interval 30.29 to 35.99
|
33.39 kg/m²
Interval 30.45 to 36.33
|
|
Body Mass Index (BMI)
12 months post-intervention
|
32.75 kg/m²
Interval 29.82 to 35.69
|
32.84 kg/m²
Interval 29.81 to 35.86
|
|
Body Mass Index (BMI)
Baseline
|
33.70 kg/m²
Interval 30.9 to 36.5
|
34.37 kg/m²
Interval 31.51 to 37.24
|
|
Body Mass Index (BMI)
Immediate post-intervention
|
33.54 kg/m²
Interval 30.72 to 36.36
|
33.65 kg/m²
Interval 30.71 to 36.59
|
SECONDARY outcome
Timeframe: Baseline; Immediate post-intervention; 6 months post-intervention; 12 months post-interventionPopulation: This study adopted an intent-to-treat approach such that data from all randomly assigned participants (N=416) were included in analyses. To address missing data, we used the random forest method in multiple imputation by chained equations (MICE; m=50).
Blood pressure was measured with a digital blood pressure device with the participant seated and arm elevated to place the cuff approximately at heart height. Two blood pressure measurements were taken, waiting at least one minute between readings. If there was a \>5mmHg difference between the first and second reading, an additional two measurements were taken. The mean of the two (or four) measurements was recorded and used in analysis.
Outcome measures
| Measure |
CDCES Consultation Only
n=211 Participants
Participants randomized to this study arm receive the standard of care at the clinic from which they were recruited, plus a 60 minute healthy eating consultation with a Certified Diabetes Care and Education Specialist and a food pantry resource guide specific to their community.
CDCES Consultation Only: Participants randomized to this study arm receive the standard of care at the clinic from which they were recruited, plus a 60 minute healthy eating consultation with a Certified Diabetes Care and Education Specialist and a food pantry resource guide specific to their community.
|
Healthy Food Delivery Intervention
n=205 Participants
In addition to standard of care and the CDCES consultation, participants randomized to the Healthy Food Delivery arm receive weekly home delivery of type 2 diabetes-appropriate food boxes over 3 months (12 food boxes in total).
Healthy Food Delivery Intervention: Participants randomized to the Healthy Food Delivery Intervention receive standard of care, a CDCES Consultation, food pantry resource guide, and weekly home delivery of type 2 diabetes-appropriate food boxes over 3 months (12 food boxes in total).Each food box included approximately 9000 calories of food. Food boxes were designed by a Registered Dietician. Food boxes also included recipes and cooking tips specific to foods included in that week's box.
|
|---|---|---|
|
Systolic Blood Pressure (SBP)
Baseline
|
130.75 mmHg
Interval 125.13 to 136.37
|
133.38 mmHg
Interval 127.64 to 139.12
|
|
Systolic Blood Pressure (SBP)
Immediate post-intervention
|
132.08 mmHg
Interval 126.2 to 137.95
|
132.77 mmHg
Interval 126.89 to 138.65
|
|
Systolic Blood Pressure (SBP)
6 Months post-intervention
|
131.99 mmHg
Interval 126.14 to 137.83
|
133.00 mmHg
Interval 127.02 to 138.99
|
|
Systolic Blood Pressure (SBP)
12 Months post-intervention
|
131.62 mmHg
Interval 125.44 to 137.8
|
132.09 mmHg
Interval 125.92 to 138.25
|
SECONDARY outcome
Timeframe: Baseline; Immediate post-intervention; 6 months post-intervention; 12 months post-interventionPopulation: This study adopted an intent-to-treat approach such that data from all randomly assigned participants (N=416) were included in analyses. To address missing data, we used the random forest method in multiple imputation by chained equations (MICE; m=50).
Blood pressure was measured with a digital blood pressure device with the participant seated and arm elevated to place the cuff approximately at heart height. Two blood pressure measurements were taken, waiting at least one minute between readings. If there was a \>5mmHg difference between the first and second reading, an additional two measurements were taken. The mean of the two (or four) measurements was recorded and used in analysis.
Outcome measures
| Measure |
CDCES Consultation Only
n=211 Participants
Participants randomized to this study arm receive the standard of care at the clinic from which they were recruited, plus a 60 minute healthy eating consultation with a Certified Diabetes Care and Education Specialist and a food pantry resource guide specific to their community.
CDCES Consultation Only: Participants randomized to this study arm receive the standard of care at the clinic from which they were recruited, plus a 60 minute healthy eating consultation with a Certified Diabetes Care and Education Specialist and a food pantry resource guide specific to their community.
|
Healthy Food Delivery Intervention
n=205 Participants
In addition to standard of care and the CDCES consultation, participants randomized to the Healthy Food Delivery arm receive weekly home delivery of type 2 diabetes-appropriate food boxes over 3 months (12 food boxes in total).
Healthy Food Delivery Intervention: Participants randomized to the Healthy Food Delivery Intervention receive standard of care, a CDCES Consultation, food pantry resource guide, and weekly home delivery of type 2 diabetes-appropriate food boxes over 3 months (12 food boxes in total).Each food box included approximately 9000 calories of food. Food boxes were designed by a Registered Dietician. Food boxes also included recipes and cooking tips specific to foods included in that week's box.
|
|---|---|---|
|
Diastolic Blood Pressure (DBP)
Baseline
|
78.18 mmHg
Interval 74.46 to 81.9
|
79.06 mmHg
Interval 75.26 to 82.87
|
|
Diastolic Blood Pressure (DBP)
Immediate post-intervention
|
78.00 mmHg
Interval 74.12 to 81.87
|
77.87 mmHg
Interval 74.04 to 81.7
|
|
Diastolic Blood Pressure (DBP)
6 Months post-intervention
|
77.63 mmHg
Interval 73.62 to 81.63
|
78.42 mmHg
Interval 74.51 to 82.34
|
|
Diastolic Blood Pressure (DBP)
12 Months post-intervention
|
78.07 mmHg
Interval 73.89 to 82.26
|
77.89 mmHg
Interval 73.91 to 81.88
|
SECONDARY outcome
Timeframe: Baseline; Immediate post-intervention; 6 months post-intervention; 12 months post-interventionPopulation: This study adopted an intent-to-treat approach such that data from all randomly assigned participants (N=416) were included in analyses. To address missing data, we used the random forest method in multiple imputation by chained equations (MICE; m=50).
Through finger prick blood collection, point of care tests were used to collect lipids using a commercial lipid panel kit and Cholestech LDX analyzer.
Outcome measures
| Measure |
CDCES Consultation Only
n=211 Participants
Participants randomized to this study arm receive the standard of care at the clinic from which they were recruited, plus a 60 minute healthy eating consultation with a Certified Diabetes Care and Education Specialist and a food pantry resource guide specific to their community.
CDCES Consultation Only: Participants randomized to this study arm receive the standard of care at the clinic from which they were recruited, plus a 60 minute healthy eating consultation with a Certified Diabetes Care and Education Specialist and a food pantry resource guide specific to their community.
|
Healthy Food Delivery Intervention
n=205 Participants
In addition to standard of care and the CDCES consultation, participants randomized to the Healthy Food Delivery arm receive weekly home delivery of type 2 diabetes-appropriate food boxes over 3 months (12 food boxes in total).
Healthy Food Delivery Intervention: Participants randomized to the Healthy Food Delivery Intervention receive standard of care, a CDCES Consultation, food pantry resource guide, and weekly home delivery of type 2 diabetes-appropriate food boxes over 3 months (12 food boxes in total).Each food box included approximately 9000 calories of food. Food boxes were designed by a Registered Dietician. Food boxes also included recipes and cooking tips specific to foods included in that week's box.
|
|---|---|---|
|
Total Cholesterol
Baseline
|
167.94 mg/dL
Interval 152.38 to 183.5
|
172.17 mg/dL
Interval 156.36 to 187.98
|
|
Total Cholesterol
Immediate post-intervention
|
167.42 mg/dL
Interval 152.0 to 182.83
|
165.34 mg/dL
Interval 149.73 to 180.94
|
|
Total Cholesterol
6 Months post-intervention
|
166.47 mg/dL
Interval 150.18 to 182.75
|
168.31 mg/dL
Interval 152.07 to 184.54
|
|
Total Cholesterol
12 Months post-intervention
|
162.87 mg/dL
Interval 146.31 to 179.43
|
162.17 mg/dL
Interval 145.04 to 179.29
|
SECONDARY outcome
Timeframe: Baseline; Immediate post-intervention; 6 months post-intervention; 12 months post-interventionPopulation: This study adopted an intent-to-treat approach such that data from all randomly assigned participants (N=416) were included in analyses. To address missing data, we used the random forest method in multiple imputation by chained equations (MICE; m=50).
Through finger prick blood collection, point of care tests were used to collect HDL using a commercial lipid panel kit and Cholestech LDX analyzer.
Outcome measures
| Measure |
CDCES Consultation Only
n=211 Participants
Participants randomized to this study arm receive the standard of care at the clinic from which they were recruited, plus a 60 minute healthy eating consultation with a Certified Diabetes Care and Education Specialist and a food pantry resource guide specific to their community.
CDCES Consultation Only: Participants randomized to this study arm receive the standard of care at the clinic from which they were recruited, plus a 60 minute healthy eating consultation with a Certified Diabetes Care and Education Specialist and a food pantry resource guide specific to their community.
|
Healthy Food Delivery Intervention
n=205 Participants
In addition to standard of care and the CDCES consultation, participants randomized to the Healthy Food Delivery arm receive weekly home delivery of type 2 diabetes-appropriate food boxes over 3 months (12 food boxes in total).
Healthy Food Delivery Intervention: Participants randomized to the Healthy Food Delivery Intervention receive standard of care, a CDCES Consultation, food pantry resource guide, and weekly home delivery of type 2 diabetes-appropriate food boxes over 3 months (12 food boxes in total).Each food box included approximately 9000 calories of food. Food boxes were designed by a Registered Dietician. Food boxes also included recipes and cooking tips specific to foods included in that week's box.
|
|---|---|---|
|
High-Density Lipoproteins (HDL)
12 Months post-intervention
|
39.42 mg/dL
Interval 34.93 to 43.92
|
40.17 mg/dL
Interval 35.89 to 44.44
|
|
High-Density Lipoproteins (HDL)
6 Months post-intervention
|
41.01 mg/dL
Interval 36.78 to 45.23
|
40.54 mg/dL
Interval 35.87 to 45.22
|
|
High-Density Lipoproteins (HDL)
Baseline
|
38.24 mg/dL
Interval 34.22 to 42.25
|
39.75 mg/dL
Interval 35.62 to 43.87
|
|
High-Density Lipoproteins (HDL)
Immediate post-intervention
|
38.97 mg/dL
Interval 34.82 to 43.13
|
40.03 mg/dL
Interval 35.66 to 44.4
|
SECONDARY outcome
Timeframe: Baseline; Immediate post-intervention; 6 months post-intervention; 12 months post-interventionPopulation: This study adopted an intent-to-treat approach such that data from all randomly assigned participants (N=416) were included in analyses. To address missing data, we used the random forest method in multiple imputation by chained equations (MICE; m=50).
Through finger prick blood collection, point of care tests were used to collect LDL using a commercial lipid panel kit and Cholestech LDX analyzer.
Outcome measures
| Measure |
CDCES Consultation Only
n=211 Participants
Participants randomized to this study arm receive the standard of care at the clinic from which they were recruited, plus a 60 minute healthy eating consultation with a Certified Diabetes Care and Education Specialist and a food pantry resource guide specific to their community.
CDCES Consultation Only: Participants randomized to this study arm receive the standard of care at the clinic from which they were recruited, plus a 60 minute healthy eating consultation with a Certified Diabetes Care and Education Specialist and a food pantry resource guide specific to their community.
|
Healthy Food Delivery Intervention
n=205 Participants
In addition to standard of care and the CDCES consultation, participants randomized to the Healthy Food Delivery arm receive weekly home delivery of type 2 diabetes-appropriate food boxes over 3 months (12 food boxes in total).
Healthy Food Delivery Intervention: Participants randomized to the Healthy Food Delivery Intervention receive standard of care, a CDCES Consultation, food pantry resource guide, and weekly home delivery of type 2 diabetes-appropriate food boxes over 3 months (12 food boxes in total).Each food box included approximately 9000 calories of food. Food boxes were designed by a Registered Dietician. Food boxes also included recipes and cooking tips specific to foods included in that week's box.
|
|---|---|---|
|
Low-Density Lipoproteins (LDL)
Baseline
|
94.93 mg/dL
Interval 82.53 to 107.34
|
95.35 mg/dL
Interval 83.06 to 107.64
|
|
Low-Density Lipoproteins (LDL)
Immediate post-intervention
|
94.84 mg/dL
Interval 82.49 to 107.19
|
91.06 mg/dL
Interval 78.77 to 103.35
|
|
Low-Density Lipoproteins (LDL)
6 Months post-intervention
|
89.39 mg/dL
Interval 76.11 to 102.66
|
91.94 mg/dL
Interval 79.25 to 104.64
|
|
Low-Density Lipoproteins (LDL)
12 months post-intervention
|
91.73 mg/dL
Interval 78.31 to 105.16
|
91.06 mg/dL
Interval 77.87 to 104.24
|
SECONDARY outcome
Timeframe: Baseline; Immediate post-intervention; 6 months post-intervention; 12 months post-interventionPopulation: This study adopted an intent-to-treat approach such that data from all randomly assigned participants (N=416) were included in analyses. To address missing data, we used the random forest method in multiple imputation by chained equations (MICE; m=50).
Through finger prick blood collection, point of care tests were used to collect triglycerides using a commercial lipid panel kit and Cholestech LDX analyzer.
Outcome measures
| Measure |
CDCES Consultation Only
n=211 Participants
Participants randomized to this study arm receive the standard of care at the clinic from which they were recruited, plus a 60 minute healthy eating consultation with a Certified Diabetes Care and Education Specialist and a food pantry resource guide specific to their community.
CDCES Consultation Only: Participants randomized to this study arm receive the standard of care at the clinic from which they were recruited, plus a 60 minute healthy eating consultation with a Certified Diabetes Care and Education Specialist and a food pantry resource guide specific to their community.
|
Healthy Food Delivery Intervention
n=205 Participants
In addition to standard of care and the CDCES consultation, participants randomized to the Healthy Food Delivery arm receive weekly home delivery of type 2 diabetes-appropriate food boxes over 3 months (12 food boxes in total).
Healthy Food Delivery Intervention: Participants randomized to the Healthy Food Delivery Intervention receive standard of care, a CDCES Consultation, food pantry resource guide, and weekly home delivery of type 2 diabetes-appropriate food boxes over 3 months (12 food boxes in total).Each food box included approximately 9000 calories of food. Food boxes were designed by a Registered Dietician. Food boxes also included recipes and cooking tips specific to foods included in that week's box.
|
|---|---|---|
|
Triglycerides
Baseline
|
184.46 mg/dL
Interval 149.96 to 218.96
|
200.31 mg/dL
Interval 164.65 to 235.98
|
|
Triglycerides
Immediate post-intervention
|
192.10 mg/dL
Interval 156.96 to 227.23
|
188.26 mg/dL
Interval 152.06 to 224.47
|
|
Triglycerides
6 Months post-intervention
|
193.10 mg/dL
Interval 155.5 to 230.69
|
190.33 mg/dL
Interval 152.28 to 228.39
|
|
Triglycerides
12 Months post-intervention
|
179.79 mg/dL
Interval 143.7 to 215.87
|
168.18 mg/dL
Interval 130.12 to 206.23
|
SECONDARY outcome
Timeframe: Baseline; Immediate post-intervention; 6 months post-intervention; 12 months post-interventionPopulation: This study adopted an intent-to-treat approach such that data from all randomly assigned participants (N=416) were included in analyses. To address missing data, we used the random forest method in multiple imputation by chained equations (MICE; m=50).
Through finger prick blood collection, point of care tests were used to collect random (non-fasting) blood glucose.
Outcome measures
| Measure |
CDCES Consultation Only
n=211 Participants
Participants randomized to this study arm receive the standard of care at the clinic from which they were recruited, plus a 60 minute healthy eating consultation with a Certified Diabetes Care and Education Specialist and a food pantry resource guide specific to their community.
CDCES Consultation Only: Participants randomized to this study arm receive the standard of care at the clinic from which they were recruited, plus a 60 minute healthy eating consultation with a Certified Diabetes Care and Education Specialist and a food pantry resource guide specific to their community.
|
Healthy Food Delivery Intervention
n=205 Participants
In addition to standard of care and the CDCES consultation, participants randomized to the Healthy Food Delivery arm receive weekly home delivery of type 2 diabetes-appropriate food boxes over 3 months (12 food boxes in total).
Healthy Food Delivery Intervention: Participants randomized to the Healthy Food Delivery Intervention receive standard of care, a CDCES Consultation, food pantry resource guide, and weekly home delivery of type 2 diabetes-appropriate food boxes over 3 months (12 food boxes in total).Each food box included approximately 9000 calories of food. Food boxes were designed by a Registered Dietician. Food boxes also included recipes and cooking tips specific to foods included in that week's box.
|
|---|---|---|
|
Glucose
12 Months post-intervention
|
172.37 mg/dL
Interval 149.75 to 194.98
|
170.95 mg/dL
Interval 147.75 to 194.14
|
|
Glucose
Baseline
|
188.74 mg/dL
Interval 167.98 to 209.49
|
187.76 mg/dL
Interval 166.3 to 209.22
|
|
Glucose
Immediate post-intervention
|
195.01 mg/dL
Interval 172.1 to 217.92
|
185.73 mg/dL
Interval 162.73 to 208.74
|
|
Glucose
6 Months post-intervention
|
192.22 mg/dL
Interval 167.53 to 216.91
|
189.77 mg/dL
Interval 166.78 to 212.76
|
SECONDARY outcome
Timeframe: Baseline; Immediate post-intervention; 6 months post-intervention; 12 months post-interventionPopulation: This study adopted an intent-to-treat approach such that data from all randomly assigned participants (N=416) were included in analyses. To address missing data, we used the random forest method in multiple imputation by chained equations (MICE; m=50).
The Diabetes Management Self-Efficacy Scale (DMSES) was used to measure patient's confidence in managing their diabetes. The DMSES assesses self-reported confidence in managing multiple aspects of their diabetes. The item reponses range from 1 (not at all confident) to 10 (totally confident) and are averaged to generate composite scores, with higher scores indicating higher levels of self-efficacy.
Outcome measures
| Measure |
CDCES Consultation Only
n=211 Participants
Participants randomized to this study arm receive the standard of care at the clinic from which they were recruited, plus a 60 minute healthy eating consultation with a Certified Diabetes Care and Education Specialist and a food pantry resource guide specific to their community.
CDCES Consultation Only: Participants randomized to this study arm receive the standard of care at the clinic from which they were recruited, plus a 60 minute healthy eating consultation with a Certified Diabetes Care and Education Specialist and a food pantry resource guide specific to their community.
|
Healthy Food Delivery Intervention
n=205 Participants
In addition to standard of care and the CDCES consultation, participants randomized to the Healthy Food Delivery arm receive weekly home delivery of type 2 diabetes-appropriate food boxes over 3 months (12 food boxes in total).
Healthy Food Delivery Intervention: Participants randomized to the Healthy Food Delivery Intervention receive standard of care, a CDCES Consultation, food pantry resource guide, and weekly home delivery of type 2 diabetes-appropriate food boxes over 3 months (12 food boxes in total).Each food box included approximately 9000 calories of food. Food boxes were designed by a Registered Dietician. Food boxes also included recipes and cooking tips specific to foods included in that week's box.
|
|---|---|---|
|
Diabetes Self-Efficacy (DMSES)
Baseline
|
7.38 score on a scale
Interval 6.92 to 7.83
|
7.24 score on a scale
Interval 6.77 to 7.71
|
|
Diabetes Self-Efficacy (DMSES)
Immediate post-intervention
|
7.58 score on a scale
Interval 7.1 to 8.05
|
7.61 score on a scale
Interval 7.13 to 8.1
|
|
Diabetes Self-Efficacy (DMSES)
6 Months post-intervention
|
7.67 score on a scale
Interval 7.18 to 8.16
|
7.62 score on a scale
Interval 7.13 to 8.1
|
|
Diabetes Self-Efficacy (DMSES)
12 Months post-intervention
|
7.69 score on a scale
Interval 7.21 to 8.17
|
7.72 score on a scale
Interval 7.22 to 8.22
|
SECONDARY outcome
Timeframe: Baseline; Immediate post-intervention; 6 months post-intervention; 12 months post-interventionPopulation: This study adopted an intent-to-treat approach such that data from all randomly assigned participants (N=416) were included in analyses. To address missing data, we used the random forest method in multiple imputation by chained equations (MICE; m=50).
The Problem Areas in Diabetes scale (PAID-5) was used to measure diabetes-related distress. The PAID-5 consists of 5 items to assess self-reported diabetes-related emotional distress, including feeling scared or depressed. Item responses range from 0 (not a problem) to 4 (serious problem) and are summed to produce an overall composite score, with a total score of 8 or higher indicating possible diabetes-related emotional distress.
Outcome measures
| Measure |
CDCES Consultation Only
n=211 Participants
Participants randomized to this study arm receive the standard of care at the clinic from which they were recruited, plus a 60 minute healthy eating consultation with a Certified Diabetes Care and Education Specialist and a food pantry resource guide specific to their community.
CDCES Consultation Only: Participants randomized to this study arm receive the standard of care at the clinic from which they were recruited, plus a 60 minute healthy eating consultation with a Certified Diabetes Care and Education Specialist and a food pantry resource guide specific to their community.
|
Healthy Food Delivery Intervention
n=205 Participants
In addition to standard of care and the CDCES consultation, participants randomized to the Healthy Food Delivery arm receive weekly home delivery of type 2 diabetes-appropriate food boxes over 3 months (12 food boxes in total).
Healthy Food Delivery Intervention: Participants randomized to the Healthy Food Delivery Intervention receive standard of care, a CDCES Consultation, food pantry resource guide, and weekly home delivery of type 2 diabetes-appropriate food boxes over 3 months (12 food boxes in total).Each food box included approximately 9000 calories of food. Food boxes were designed by a Registered Dietician. Food boxes also included recipes and cooking tips specific to foods included in that week's box.
|
|---|---|---|
|
Diabetes-Related Distress (PAID-5)
Baseline
|
5.17 score on a scale
Interval 3.52 to 6.82
|
5.33 score on a scale
Interval 3.65 to 7.01
|
|
Diabetes-Related Distress (PAID-5)
Immediate post-intervention
|
4.31 score on a scale
Interval 2.62 to 6.0
|
4.54 score on a scale
Interval 2.84 to 6.23
|
|
Diabetes-Related Distress (PAID-5)
6 Months post-intervention
|
4.35 score on a scale
Interval 2.69 to 6.01
|
4.07 score on a scale
Interval 2.34 to 5.8
|
|
Diabetes-Related Distress (PAID-5)
12 Months post-intervention
|
3.85 score on a scale
Interval 2.2 to 5.5
|
3.80 score on a scale
Interval 2.09 to 5.51
|
SECONDARY outcome
Timeframe: Baseline; Immediate post-intervention; 6 months post-intervention; 12 months post-interventionPopulation: This study adopted an intent-to-treat approach such that data from all randomly assigned participants (N=416) were included in analyses. To address missing data, we used the random forest method in multiple imputation by chained equations (MICE; m=50).
Food insecurity was assessed using the 2-item Hunger Vital Sign. Affirmative answers ("Often True" or "Sometimes True") to either of the 2 screener items indicates food insecurity. Food insecurity was treated as a binary outcome (0=food secure, 1=food insecure).
Outcome measures
| Measure |
CDCES Consultation Only
n=211 Participants
Participants randomized to this study arm receive the standard of care at the clinic from which they were recruited, plus a 60 minute healthy eating consultation with a Certified Diabetes Care and Education Specialist and a food pantry resource guide specific to their community.
CDCES Consultation Only: Participants randomized to this study arm receive the standard of care at the clinic from which they were recruited, plus a 60 minute healthy eating consultation with a Certified Diabetes Care and Education Specialist and a food pantry resource guide specific to their community.
|
Healthy Food Delivery Intervention
n=205 Participants
In addition to standard of care and the CDCES consultation, participants randomized to the Healthy Food Delivery arm receive weekly home delivery of type 2 diabetes-appropriate food boxes over 3 months (12 food boxes in total).
Healthy Food Delivery Intervention: Participants randomized to the Healthy Food Delivery Intervention receive standard of care, a CDCES Consultation, food pantry resource guide, and weekly home delivery of type 2 diabetes-appropriate food boxes over 3 months (12 food boxes in total).Each food box included approximately 9000 calories of food. Food boxes were designed by a Registered Dietician. Food boxes also included recipes and cooking tips specific to foods included in that week's box.
|
|---|---|---|
|
Food Insecurity
Baseline
|
0.84 predicted probability
Interval 0.64 to 0.94
|
0.85 predicted probability
Interval 0.65 to 0.95
|
|
Food Insecurity
Immediate post-intervention
|
0.26 predicted probability
Interval 0.11 to 0.52
|
0.35 predicted probability
Interval 0.15 to 0.63
|
|
Food Insecurity
6 Months post-intervention
|
0.15 predicted probability
Interval 0.05 to 0.35
|
0.19 predicted probability
Interval 0.07 to 0.42
|
|
Food Insecurity
12 Months post-intervention
|
0.23 predicted probability
Interval 0.09 to 0.48
|
0.24 predicted probability
Interval 0.09 to 0.5
|
Adverse Events
CDCES Consultation Only
Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths
Healthy Food Delivery Intervention
Serious events: 1 serious events
Other events: 0 other events
Deaths: 9 deaths
Serious adverse events
| Measure |
CDCES Consultation Only
n=211 participants at risk
Participants randomized to this study arm receive the standard of care at the clinic from which they were recruited, plus a 60 minute healthy eating consultation with a Certified Diabetes Care and Education Specialist and a food pantry resource guide specific to their community.
CDCES Consultation Only: Participants randomized to this study arm receive the standard of care at the clinic from which they were recruited, plus a 60 minute healthy eating consultation with a Certified Diabetes Care and Education Specialist and a food pantry resource guide specific to their community.
|
Healthy Food Delivery Intervention
n=205 participants at risk
In addition to standard of care and the CDCES consultation, participants randomized to the Healthy Food Delivery arm receive weekly home delivery of type 2 diabetes-appropriate food boxes over 3 months (12 food boxes in total).
Healthy Food Delivery Intervention: Participants randomized to the Healthy Food Delivery Intervention receive standard of care, a CDCES Consultation, food pantry resource guide, and weekly home delivery of type 2 diabetes-appropriate food boxes over 3 months (12 food boxes in total).Each food box included approximately 9000 calories of food. Food boxes were designed by a Registered Dietician. Food boxes also included recipes and cooking tips specific to foods included in that week's box.
|
|---|---|---|
|
Surgical and medical procedures
Poor health
|
0.00%
0/211 • From study enrollment to approximately 1 year and 3 months post-enrollment.
|
0.49%
1/205 • Number of events 1 • From study enrollment to approximately 1 year and 3 months post-enrollment.
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Pearl McElfish
University of Arkansas for Medical Sciences
Phone: 479-713-8102
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place