Trial Outcomes & Findings for CTSI Pilot: Improving Adherence to Diabetic Diet (NCT NCT04051008)
NCT ID: NCT04051008
Last Updated: 2023-12-13
Results Overview
Receipt data will be entered into Nutritionist Pro software and will be used to calculate total calories purchased from target grocery stores.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
65 participants
Primary outcome timeframe
At post-test (week 5)
Results posted on
2023-12-13
Participant Flow
Participant milestones
| Measure |
Group 1 - Control
No intervention - participants will shop in-person as they usually would. Participants will receive recipe cards that follow the evidence-based DASH diet and correspond to dietary recommendations for diabetic patients.
|
Group 2 - Online
Participants will utilize online grocery shopping (shopping at a local grocery store via an online platform). Participants will also receive recipe cards that follow the evidence-based DASH diet and correspond to dietary recommendations for diabetic patients.
Online - use of online grocery shopping platform: The Online intervention will utilize online grocery shopping (shopping at a local grocery store via online platform).
|
Group 3 - Default
The default intervention will augment the Online intervention, showing participants a default cart when they log into their online grocery shopping accounts. They will be told that their cart has been filled with items that conform to a diabetic diet and can be used to make recipes from the provided recipe cards, and that they can modify it as they like. Participants will also receive recipe cards that follow the evidence-based DASH diet and correspond to dietary recommendations for diabetic patients.
Default - use of online grocery shopping platform with default shopping carts: The Defaults intervention, will augment the Online intervention, showing participants a default cart when they log into their online grocery shopping accounts. They will be told that their cart has been filled with items that conform to a diabetic diet and can be used to make the recipes from provided recipe cards, and that they may modify their cart as they like.
|
|---|---|---|---|
|
Overall Study
STARTED
|
21
|
21
|
23
|
|
Overall Study
COMPLETED
|
19
|
21
|
22
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
1
|
Reasons for withdrawal
| Measure |
Group 1 - Control
No intervention - participants will shop in-person as they usually would. Participants will receive recipe cards that follow the evidence-based DASH diet and correspond to dietary recommendations for diabetic patients.
|
Group 2 - Online
Participants will utilize online grocery shopping (shopping at a local grocery store via an online platform). Participants will also receive recipe cards that follow the evidence-based DASH diet and correspond to dietary recommendations for diabetic patients.
Online - use of online grocery shopping platform: The Online intervention will utilize online grocery shopping (shopping at a local grocery store via online platform).
|
Group 3 - Default
The default intervention will augment the Online intervention, showing participants a default cart when they log into their online grocery shopping accounts. They will be told that their cart has been filled with items that conform to a diabetic diet and can be used to make recipes from the provided recipe cards, and that they can modify it as they like. Participants will also receive recipe cards that follow the evidence-based DASH diet and correspond to dietary recommendations for diabetic patients.
Default - use of online grocery shopping platform with default shopping carts: The Defaults intervention, will augment the Online intervention, showing participants a default cart when they log into their online grocery shopping accounts. They will be told that their cart has been filled with items that conform to a diabetic diet and can be used to make the recipes from provided recipe cards, and that they may modify their cart as they like.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
1
|
Baseline Characteristics
CTSI Pilot: Improving Adherence to Diabetic Diet
Baseline characteristics by cohort
| Measure |
Group 1 - Control
n=20 Participants
No intervention - participants will shop in-person as they usually would. Participants will receive recipe cards that follow the evidence-based DASH diet and correspond to dietary recommendations for diabetic patients.
|
Group 2 - Online
n=21 Participants
Participants will utilize online grocery shopping (shopping at a local grocery store via an online platform). Participants will also receive recipe cards that follow the evidence-based DASH diet and correspond to dietary recommendations for diabetic patients.
Online - use of online grocery shopping platform: The Online intervention will utilize online grocery shopping (shopping at a local grocery store via online platform).
|
Group 3 - Default
n=23 Participants
The default intervention will augment the Online intervention, showing participants a default cart when they log into their online grocery shopping accounts. They will be told that their cart has been filled with items that conform to a diabetic diet and can be used to make recipes from the provided recipe cards, and that they can modify it as they like. Participants will also receive recipe cards that follow the evidence-based DASH diet and correspond to dietary recommendations for diabetic patients.
Default - use of online grocery shopping platform with default shopping carts: The Defaults intervention, will augment the Online intervention, showing participants a default cart when they log into their online grocery shopping accounts. They will be told that their cart has been filled with items that conform to a diabetic diet and can be used to make the recipes from provided recipe cards, and that they may modify their cart as they like.
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
56.8 Years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
49.2 Years
STANDARD_DEVIATION 12.8 • n=7 Participants
|
53.7 Years
STANDARD_DEVIATION 8.8 • n=5 Participants
|
53.2 Years
STANDARD_DEVIATION 10.7 • n=4 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
54 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
62 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
58 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
21 participants
n=7 Participants
|
23 participants
n=5 Participants
|
64 participants
n=4 Participants
|
|
Education
High school graduate or equivalent
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Education
Some college/associate's degree
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Education
Bachelor's degree
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Education
Graduate degree
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
|
Total energy purchased
|
26116.3 kcal
STANDARD_DEVIATION 26229.4 • n=5 Participants
|
25832.2 kcal
STANDARD_DEVIATION 26229.4 • n=7 Participants
|
25481.3 kcal
STANDARD_DEVIATION 16266.5 • n=5 Participants
|
25799.8 kcal
STANDARD_DEVIATION 21272.6 • n=4 Participants
|
|
Total carbohydrates purchased
|
3335.7 grams
STANDARD_DEVIATION 3175.3 • n=5 Participants
|
2944.1 grams
STANDARD_DEVIATION 2886.1 • n=7 Participants
|
3009.2 grams
STANDARD_DEVIATION 2269.0 • n=5 Participants
|
3093.7 grams
STANDARD_DEVIATION 2748.2 • n=4 Participants
|
|
Total sugar purchased
|
1289.7 grams
STANDARD_DEVIATION 1243.9 • n=5 Participants
|
1355.7 grams
STANDARD_DEVIATION 1132.9 • n=7 Participants
|
1345.5 grams
STANDARD_DEVIATION 1065.4 • n=5 Participants
|
1330.8 grams
STANDARD_DEVIATION 1129.4 • n=4 Participants
|
|
Nutritional quality of grocery purchases
|
22.4 units on a scale
STANDARD_DEVIATION 4.5 • n=5 Participants
|
22.4 units on a scale
STANDARD_DEVIATION 3.5 • n=7 Participants
|
22.9 units on a scale
STANDARD_DEVIATION 4.8 • n=5 Participants
|
22.6 units on a scale
STANDARD_DEVIATION 4.3 • n=4 Participants
|
PRIMARY outcome
Timeframe: At post-test (week 5)Population: The sample sizes reflect the number of participants in each group who provided receipt data during Week 5 of the study
Receipt data will be entered into Nutritionist Pro software and will be used to calculate total calories purchased from target grocery stores.
Outcome measures
| Measure |
Group 1 - Control
n=19 Participants
No intervention - participants will shop in-person as they usually would. Participants will receive recipe cards that follow the evidence-based DASH diet and correspond to dietary recommendations for diabetic patients.
|
Group 2 - Online
n=19 Participants
Participants will utilize online grocery shopping (shopping at a local grocery store via an online platform). Participants will also receive recipe cards that follow the evidence-based DASH diet and correspond to dietary recommendations for diabetic patients.
Online - use of online grocery shopping platform: The Online intervention will utilize online grocery shopping (shopping at a local grocery store via online platform).
|
Group 3 - Default
n=22 Participants
The default intervention will augment the Online intervention, showing participants a default cart when they log into their online grocery shopping accounts. They will be told that their cart has been filled with items that conform to a diabetic diet and can be used to make recipes from the provided recipe cards, and that they can modify it as they like. Participants will also receive recipe cards that follow the evidence-based DASH diet and correspond to dietary recommendations for diabetic patients.
Default - use of online grocery shopping platform with default shopping carts: The Defaults intervention, will augment the Online intervention, showing participants a default cart when they log into their online grocery shopping accounts. They will be told that their cart has been filled with items that conform to a diabetic diet and can be used to make the recipes from provided recipe cards, and that they may modify their cart as they like.
|
|---|---|---|---|
|
Calories Purchased
|
24443.30 Kcal
Standard Deviation 14918.22
|
25339.20 Kcal
Standard Deviation 19069.60
|
18527.35 Kcal
Standard Deviation 15025.35
|
PRIMARY outcome
Timeframe: Weeks 1-5 (testing overall main effect of study group)Population: All randomized participants were included in the repeated measures ANOVAs assessing the overall main effect of study group. Means reported below are least squares means representing calories purchased in each group overall across the time points
Receipt data are entered into Nutritionist Pro software and used to calculate total calories purchased from target grocery stores each week. For this analysis, the weekly values were aggregated, such that the least squares means reported herein represent average calories purchased across all 5 weeks, in the context of the repeated measures ANOVA model.
Outcome measures
| Measure |
Group 1 - Control
n=21 Participants
No intervention - participants will shop in-person as they usually would. Participants will receive recipe cards that follow the evidence-based DASH diet and correspond to dietary recommendations for diabetic patients.
|
Group 2 - Online
n=21 Participants
Participants will utilize online grocery shopping (shopping at a local grocery store via an online platform). Participants will also receive recipe cards that follow the evidence-based DASH diet and correspond to dietary recommendations for diabetic patients.
Online - use of online grocery shopping platform: The Online intervention will utilize online grocery shopping (shopping at a local grocery store via online platform).
|
Group 3 - Default
n=23 Participants
The default intervention will augment the Online intervention, showing participants a default cart when they log into their online grocery shopping accounts. They will be told that their cart has been filled with items that conform to a diabetic diet and can be used to make recipes from the provided recipe cards, and that they can modify it as they like. Participants will also receive recipe cards that follow the evidence-based DASH diet and correspond to dietary recommendations for diabetic patients.
Default - use of online grocery shopping platform with default shopping carts: The Defaults intervention, will augment the Online intervention, showing participants a default cart when they log into their online grocery shopping accounts. They will be told that their cart has been filled with items that conform to a diabetic diet and can be used to make the recipes from provided recipe cards, and that they may modify their cart as they like.
|
|---|---|---|---|
|
Calories Purchased
|
25768 Kcal
Standard Deviation 14908.1
|
23479 Kcal
Standard Deviation 14870.5
|
20236 Kcal
Standard Deviation 14948.3
|
PRIMARY outcome
Timeframe: Baseline (week 1), intervention (weeks 2-4), and post-test (week 5)Population: The intent of this analysis was to examine whether there were group differences in change in the specified outcome among all participants randomized. We report here the difference in least squares means within each group from week 1 to week 5.
Receipt data will be entered into Nutritionist Pro and will be used to calculate changes in total calories purchased from target grocery stores.
Outcome measures
| Measure |
Group 1 - Control
n=19 Participants
No intervention - participants will shop in-person as they usually would. Participants will receive recipe cards that follow the evidence-based DASH diet and correspond to dietary recommendations for diabetic patients.
|
Group 2 - Online
n=19 Participants
Participants will utilize online grocery shopping (shopping at a local grocery store via an online platform). Participants will also receive recipe cards that follow the evidence-based DASH diet and correspond to dietary recommendations for diabetic patients.
Online - use of online grocery shopping platform: The Online intervention will utilize online grocery shopping (shopping at a local grocery store via online platform).
|
Group 3 - Default
n=22 Participants
The default intervention will augment the Online intervention, showing participants a default cart when they log into their online grocery shopping accounts. They will be told that their cart has been filled with items that conform to a diabetic diet and can be used to make recipes from the provided recipe cards, and that they can modify it as they like. Participants will also receive recipe cards that follow the evidence-based DASH diet and correspond to dietary recommendations for diabetic patients.
Default - use of online grocery shopping platform with default shopping carts: The Defaults intervention, will augment the Online intervention, showing participants a default cart when they log into their online grocery shopping accounts. They will be told that their cart has been filled with items that conform to a diabetic diet and can be used to make the recipes from provided recipe cards, and that they may modify their cart as they like.
|
|---|---|---|---|
|
Change in Calories Purchased
|
-2661.91 kilocalories
Standard Error 4023.56
|
-1533.34 kilocalories
Standard Error 4016.82
|
-6892.76 kilocalories
Standard Error 3786.38
|
PRIMARY outcome
Timeframe: At post-test (week 5)Population: Represents those with receipt data at post-test (week 5)
Receipt data will be entered into Nutritionist Pro and will be used to calculate carbohydrates purchased from target grocery stores.
Outcome measures
| Measure |
Group 1 - Control
n=19 Participants
No intervention - participants will shop in-person as they usually would. Participants will receive recipe cards that follow the evidence-based DASH diet and correspond to dietary recommendations for diabetic patients.
|
Group 2 - Online
n=19 Participants
Participants will utilize online grocery shopping (shopping at a local grocery store via an online platform). Participants will also receive recipe cards that follow the evidence-based DASH diet and correspond to dietary recommendations for diabetic patients.
Online - use of online grocery shopping platform: The Online intervention will utilize online grocery shopping (shopping at a local grocery store via online platform).
|
Group 3 - Default
n=22 Participants
The default intervention will augment the Online intervention, showing participants a default cart when they log into their online grocery shopping accounts. They will be told that their cart has been filled with items that conform to a diabetic diet and can be used to make recipes from the provided recipe cards, and that they can modify it as they like. Participants will also receive recipe cards that follow the evidence-based DASH diet and correspond to dietary recommendations for diabetic patients.
Default - use of online grocery shopping platform with default shopping carts: The Defaults intervention, will augment the Online intervention, showing participants a default cart when they log into their online grocery shopping accounts. They will be told that their cart has been filled with items that conform to a diabetic diet and can be used to make the recipes from provided recipe cards, and that they may modify their cart as they like.
|
|---|---|---|---|
|
Carbohydrates Purchased
|
3320.09 grams
Standard Deviation 2231.52
|
3153.88 grams
Standard Deviation 2805.51
|
2417.95 grams
Standard Deviation 2056.82
|
PRIMARY outcome
Timeframe: Weeks 1-5 (testing overall main effect of study group)Population: All randomized participants were included in the repeated measures ANOVAs assessing the overall main effect of study group. Means reported below are least squares means representing carbohydrates purchased in each group overall across the time points
Receipt data are entered into Nutritionist Pro and used to calculate carbohydrates purchased from target grocery stores each week. For this analysis, the weekly values were aggregated, such that the least squares means reported herein represent average carbohydrates (grams) purchased across all 5 weeks, in the context of the repeated measures ANOVA model.
Outcome measures
| Measure |
Group 1 - Control
n=21 Participants
No intervention - participants will shop in-person as they usually would. Participants will receive recipe cards that follow the evidence-based DASH diet and correspond to dietary recommendations for diabetic patients.
|
Group 2 - Online
n=21 Participants
Participants will utilize online grocery shopping (shopping at a local grocery store via an online platform). Participants will also receive recipe cards that follow the evidence-based DASH diet and correspond to dietary recommendations for diabetic patients.
Online - use of online grocery shopping platform: The Online intervention will utilize online grocery shopping (shopping at a local grocery store via online platform).
|
Group 3 - Default
n=23 Participants
The default intervention will augment the Online intervention, showing participants a default cart when they log into their online grocery shopping accounts. They will be told that their cart has been filled with items that conform to a diabetic diet and can be used to make recipes from the provided recipe cards, and that they can modify it as they like. Participants will also receive recipe cards that follow the evidence-based DASH diet and correspond to dietary recommendations for diabetic patients.
Default - use of online grocery shopping platform with default shopping carts: The Defaults intervention, will augment the Online intervention, showing participants a default cart when they log into their online grocery shopping accounts. They will be told that their cart has been filled with items that conform to a diabetic diet and can be used to make the recipes from provided recipe cards, and that they may modify their cart as they like.
|
|---|---|---|---|
|
Carbohydrates Purchased
|
3200.85 grams
Standard Deviation 1961.80
|
2760.89 grams
Standard Deviation 1955.66
|
2502.41 grams
Standard Deviation 1968.88
|
PRIMARY outcome
Timeframe: Baseline (week 1), intervention (weeks 2-4), and post-test (week 5)Population: The intent of this analysis was to examine whether there were group differences in change in the specified outcome among all participants randomized. We report here the difference in least squares means within each group from week 1 to week 5.
Receipt data will be entered into Nutritionist Pro and will be used to calculate changes in carbohydrates purchased from target grocery stores.
Outcome measures
| Measure |
Group 1 - Control
n=19 Participants
No intervention - participants will shop in-person as they usually would. Participants will receive recipe cards that follow the evidence-based DASH diet and correspond to dietary recommendations for diabetic patients.
|
Group 2 - Online
n=19 Participants
Participants will utilize online grocery shopping (shopping at a local grocery store via an online platform). Participants will also receive recipe cards that follow the evidence-based DASH diet and correspond to dietary recommendations for diabetic patients.
Online - use of online grocery shopping platform: The Online intervention will utilize online grocery shopping (shopping at a local grocery store via online platform).
|
Group 3 - Default
n=22 Participants
The default intervention will augment the Online intervention, showing participants a default cart when they log into their online grocery shopping accounts. They will be told that their cart has been filled with items that conform to a diabetic diet and can be used to make recipes from the provided recipe cards, and that they can modify it as they like. Participants will also receive recipe cards that follow the evidence-based DASH diet and correspond to dietary recommendations for diabetic patients.
Default - use of online grocery shopping platform with default shopping carts: The Defaults intervention, will augment the Online intervention, showing participants a default cart when they log into their online grocery shopping accounts. They will be told that their cart has been filled with items that conform to a diabetic diet and can be used to make the recipes from provided recipe cards, and that they may modify their cart as they like.
|
|---|---|---|---|
|
Change in Carbohydrates Purchased
|
-102.78 grams
Standard Error 621.18
|
-119.84 grams
Standard Error 620.36
|
-575.67 grams
Standard Error 588.96
|
PRIMARY outcome
Timeframe: At post-test (week 5)Population: Represents those with receipt data at post-test (week 5)
Receipt data will be entered into Nutritionist Pro and will be used to calculate sugars purchased from target grocery stores.
Outcome measures
| Measure |
Group 1 - Control
n=19 Participants
No intervention - participants will shop in-person as they usually would. Participants will receive recipe cards that follow the evidence-based DASH diet and correspond to dietary recommendations for diabetic patients.
|
Group 2 - Online
n=19 Participants
Participants will utilize online grocery shopping (shopping at a local grocery store via an online platform). Participants will also receive recipe cards that follow the evidence-based DASH diet and correspond to dietary recommendations for diabetic patients.
Online - use of online grocery shopping platform: The Online intervention will utilize online grocery shopping (shopping at a local grocery store via online platform).
|
Group 3 - Default
n=22 Participants
The default intervention will augment the Online intervention, showing participants a default cart when they log into their online grocery shopping accounts. They will be told that their cart has been filled with items that conform to a diabetic diet and can be used to make recipes from the provided recipe cards, and that they can modify it as they like. Participants will also receive recipe cards that follow the evidence-based DASH diet and correspond to dietary recommendations for diabetic patients.
Default - use of online grocery shopping platform with default shopping carts: The Defaults intervention, will augment the Online intervention, showing participants a default cart when they log into their online grocery shopping accounts. They will be told that their cart has been filled with items that conform to a diabetic diet and can be used to make the recipes from provided recipe cards, and that they may modify their cart as they like.
|
|---|---|---|---|
|
Sugars Purchased
|
1212.27 grams
Standard Deviation 985.07
|
1026.31 grams
Standard Deviation 809.66
|
1024.99 grams
Standard Deviation 873.16
|
PRIMARY outcome
Timeframe: Weeks 1-5 (testing overall main effect of study group)Population: All randomized participants were included in the repeated measures ANOVAs assessing the overall main effect of study group. Means reported below are least squares means representing calories purchased in each group overall across the time points
Receipt data are entered into Nutritionist Pro software and used to calculate total sugar purchased from target grocery stores each week. For this analysis, the weekly values were aggregated, such that the least squares means reported herein represent average sugar (grams) purchased across all 5 weeks, in the context of the repeated measures ANOVA model.
Outcome measures
| Measure |
Group 1 - Control
n=21 Participants
No intervention - participants will shop in-person as they usually would. Participants will receive recipe cards that follow the evidence-based DASH diet and correspond to dietary recommendations for diabetic patients.
|
Group 2 - Online
n=21 Participants
Participants will utilize online grocery shopping (shopping at a local grocery store via an online platform). Participants will also receive recipe cards that follow the evidence-based DASH diet and correspond to dietary recommendations for diabetic patients.
Online - use of online grocery shopping platform: The Online intervention will utilize online grocery shopping (shopping at a local grocery store via online platform).
|
Group 3 - Default
n=23 Participants
The default intervention will augment the Online intervention, showing participants a default cart when they log into their online grocery shopping accounts. They will be told that their cart has been filled with items that conform to a diabetic diet and can be used to make recipes from the provided recipe cards, and that they can modify it as they like. Participants will also receive recipe cards that follow the evidence-based DASH diet and correspond to dietary recommendations for diabetic patients.
Default - use of online grocery shopping platform with default shopping carts: The Defaults intervention, will augment the Online intervention, showing participants a default cart when they log into their online grocery shopping accounts. They will be told that their cart has been filled with items that conform to a diabetic diet and can be used to make the recipes from provided recipe cards, and that they may modify their cart as they like.
|
|---|---|---|---|
|
Sugars Purchased
|
1271.2 grams
Standard Deviation 905.47
|
1110.85 grams
Standard Deviation 902.90
|
1035.17 grams
Standard Deviation 907.99
|
PRIMARY outcome
Timeframe: Baseline (week 1), intervention (weeks 2-4), and post-test (week 5)Population: The intent of this analysis was to examine whether there were group differences in change in the specified outcome among all participants randomized. We report here the difference in least squares means within each group from week 1 to week 5.
Receipt data will be entered into Nutritionist Pro and will be used to calculate changes in sugars purchased from target grocery stores.
Outcome measures
| Measure |
Group 1 - Control
n=19 Participants
No intervention - participants will shop in-person as they usually would. Participants will receive recipe cards that follow the evidence-based DASH diet and correspond to dietary recommendations for diabetic patients.
|
Group 2 - Online
n=19 Participants
Participants will utilize online grocery shopping (shopping at a local grocery store via an online platform). Participants will also receive recipe cards that follow the evidence-based DASH diet and correspond to dietary recommendations for diabetic patients.
Online - use of online grocery shopping platform: The Online intervention will utilize online grocery shopping (shopping at a local grocery store via online platform).
|
Group 3 - Default
n=22 Participants
The default intervention will augment the Online intervention, showing participants a default cart when they log into their online grocery shopping accounts. They will be told that their cart has been filled with items that conform to a diabetic diet and can be used to make recipes from the provided recipe cards, and that they can modify it as they like. Participants will also receive recipe cards that follow the evidence-based DASH diet and correspond to dietary recommendations for diabetic patients.
Default - use of online grocery shopping platform with default shopping carts: The Defaults intervention, will augment the Online intervention, showing participants a default cart when they log into their online grocery shopping accounts. They will be told that their cart has been filled with items that conform to a diabetic diet and can be used to make the recipes from provided recipe cards, and that they may modify their cart as they like.
|
|---|---|---|---|
|
Change in Sugars Purchased
|
-138.31 grams
Standard Error 265.25
|
-374.92 grams
Standard Error 264.84
|
-308.32 grams
Standard Error 249.56
|
PRIMARY outcome
Timeframe: At post-test (week 5)Population: Represents those with receipt data at post-test (week 5)
Nutritional quality of grocery purchases was created using indicators adapted from Fung 2008: fruit, vegetables, nuts/legumes, whole grains, low-fat dairy, sodium, red/processed meat, carbohydrates. Quintiles were calculated for each, using the number of items from a food group or sodium \[mg\] and carbohydrates \[g\] purchased that week. Resulting scores from 1-5 indicate whether participants were lower or higher on each indicator (red meat, sodium, carbohydrates reverse scored). The 8 scores were summed for a total nutritional quality score ranging from 8 to 40 (40=highest nutritional quality).
Outcome measures
| Measure |
Group 1 - Control
n=19 Participants
No intervention - participants will shop in-person as they usually would. Participants will receive recipe cards that follow the evidence-based DASH diet and correspond to dietary recommendations for diabetic patients.
|
Group 2 - Online
n=19 Participants
Participants will utilize online grocery shopping (shopping at a local grocery store via an online platform). Participants will also receive recipe cards that follow the evidence-based DASH diet and correspond to dietary recommendations for diabetic patients.
Online - use of online grocery shopping platform: The Online intervention will utilize online grocery shopping (shopping at a local grocery store via online platform).
|
Group 3 - Default
n=22 Participants
The default intervention will augment the Online intervention, showing participants a default cart when they log into their online grocery shopping accounts. They will be told that their cart has been filled with items that conform to a diabetic diet and can be used to make recipes from the provided recipe cards, and that they can modify it as they like. Participants will also receive recipe cards that follow the evidence-based DASH diet and correspond to dietary recommendations for diabetic patients.
Default - use of online grocery shopping platform with default shopping carts: The Defaults intervention, will augment the Online intervention, showing participants a default cart when they log into their online grocery shopping accounts. They will be told that their cart has been filled with items that conform to a diabetic diet and can be used to make the recipes from provided recipe cards, and that they may modify their cart as they like.
|
|---|---|---|---|
|
Nutritional Quality of Purchases
|
20.89 units on a scale
Standard Deviation 4.37
|
20.42 units on a scale
Standard Deviation 3.22
|
21.55 units on a scale
Standard Deviation 3.02
|
PRIMARY outcome
Timeframe: Weeks 1-5 (testing overall main effect of study group)Population: All randomized participants analyzed in repeated measures ANOVA. Results reflect the average nutritional quality of purchases across all 5 study weeks (week 1-5) by group.
Nutritional quality of grocery purchases was created using indicators adapted from Fung 2008: fruit, vegetables, nuts/legumes, whole grains, low-fat dairy, sodium, red/processed meat, carbohydrates. Quintiles were calculated for each, using the number of items from a food group or sodium \[mg\] and carbohydrates \[g\] purchased that week. Resulting scores from 1-5 indicate whether participants were lower or higher on each indicator (red meat, sodium, carbohydrates reverse scored). The 8 scores were summed for a total nutritional quality score ranging from 8 to 40 (40=highest nutritional quality).
Outcome measures
| Measure |
Group 1 - Control
n=21 Participants
No intervention - participants will shop in-person as they usually would. Participants will receive recipe cards that follow the evidence-based DASH diet and correspond to dietary recommendations for diabetic patients.
|
Group 2 - Online
n=21 Participants
Participants will utilize online grocery shopping (shopping at a local grocery store via an online platform). Participants will also receive recipe cards that follow the evidence-based DASH diet and correspond to dietary recommendations for diabetic patients.
Online - use of online grocery shopping platform: The Online intervention will utilize online grocery shopping (shopping at a local grocery store via online platform).
|
Group 3 - Default
n=23 Participants
The default intervention will augment the Online intervention, showing participants a default cart when they log into their online grocery shopping accounts. They will be told that their cart has been filled with items that conform to a diabetic diet and can be used to make recipes from the provided recipe cards, and that they can modify it as they like. Participants will also receive recipe cards that follow the evidence-based DASH diet and correspond to dietary recommendations for diabetic patients.
Default - use of online grocery shopping platform with default shopping carts: The Defaults intervention, will augment the Online intervention, showing participants a default cart when they log into their online grocery shopping accounts. They will be told that their cart has been filled with items that conform to a diabetic diet and can be used to make the recipes from provided recipe cards, and that they may modify their cart as they like.
|
|---|---|---|---|
|
Nutritional Quality of Purchases
|
20.95 units on a scale
Standard Deviation 2.55
|
21.43 units on a scale
Standard Deviation 2.54
|
23.86 units on a scale
Standard Deviation 2.56
|
PRIMARY outcome
Timeframe: Baseline (week 1), intervention (weeks 2-4), and post-test (week 5)Population: The intent of this analysis was to examine whether there were group differences in change in the specified outcome among all participants randomized. We report here the difference in least squares means within each group from week 1 to week 5.
Nutritional quality of grocery purchases was created using indicators adapted from Fung 2008: fruit, vegetables, nuts/legumes, whole grains, low-fat dairy, sodium, red/processed meat, carbohydrates. Quintiles were calculated for each, using the number of items from a food group or sodium \[mg\] and carbohydrates \[g\] purchased that week. Resulting scores from 1-5 indicate whether participants were lower or higher on each indicator (red meat, sodium, carbohydrates reverse scored). The 8 scores were summed for a total nutritional quality score ranging from 8 to 40 (40=highest nutritional quality)
Outcome measures
| Measure |
Group 1 - Control
n=19 Participants
No intervention - participants will shop in-person as they usually would. Participants will receive recipe cards that follow the evidence-based DASH diet and correspond to dietary recommendations for diabetic patients.
|
Group 2 - Online
n=19 Participants
Participants will utilize online grocery shopping (shopping at a local grocery store via an online platform). Participants will also receive recipe cards that follow the evidence-based DASH diet and correspond to dietary recommendations for diabetic patients.
Online - use of online grocery shopping platform: The Online intervention will utilize online grocery shopping (shopping at a local grocery store via online platform).
|
Group 3 - Default
n=22 Participants
The default intervention will augment the Online intervention, showing participants a default cart when they log into their online grocery shopping accounts. They will be told that their cart has been filled with items that conform to a diabetic diet and can be used to make recipes from the provided recipe cards, and that they can modify it as they like. Participants will also receive recipe cards that follow the evidence-based DASH diet and correspond to dietary recommendations for diabetic patients.
Default - use of online grocery shopping platform with default shopping carts: The Defaults intervention, will augment the Online intervention, showing participants a default cart when they log into their online grocery shopping accounts. They will be told that their cart has been filled with items that conform to a diabetic diet and can be used to make the recipes from provided recipe cards, and that they may modify their cart as they like.
|
|---|---|---|---|
|
Change in Nutritional Quality of Purchases
|
-1.47 units on a scale
Standard Error 1.13
|
-2.04 units on a scale
Standard Error 1.13
|
-1.39 units on a scale
Standard Error 1.06
|
SECONDARY outcome
Timeframe: At post-test (week 5)Population: Sample sizes reflect those providing receipt data in week 5.
Total dollars spent at the target grocery stores from submitted receipts
Outcome measures
| Measure |
Group 1 - Control
n=19 Participants
No intervention - participants will shop in-person as they usually would. Participants will receive recipe cards that follow the evidence-based DASH diet and correspond to dietary recommendations for diabetic patients.
|
Group 2 - Online
n=19 Participants
Participants will utilize online grocery shopping (shopping at a local grocery store via an online platform). Participants will also receive recipe cards that follow the evidence-based DASH diet and correspond to dietary recommendations for diabetic patients.
Online - use of online grocery shopping platform: The Online intervention will utilize online grocery shopping (shopping at a local grocery store via online platform).
|
Group 3 - Default
n=22 Participants
The default intervention will augment the Online intervention, showing participants a default cart when they log into their online grocery shopping accounts. They will be told that their cart has been filled with items that conform to a diabetic diet and can be used to make recipes from the provided recipe cards, and that they can modify it as they like. Participants will also receive recipe cards that follow the evidence-based DASH diet and correspond to dietary recommendations for diabetic patients.
Default - use of online grocery shopping platform with default shopping carts: The Defaults intervention, will augment the Online intervention, showing participants a default cart when they log into their online grocery shopping accounts. They will be told that their cart has been filled with items that conform to a diabetic diet and can be used to make the recipes from provided recipe cards, and that they may modify their cart as they like.
|
|---|---|---|---|
|
Dollars Spent
|
84.71 dollars
Standard Deviation 47.05
|
88.79 dollars
Standard Deviation 61.52
|
72.59 dollars
Standard Deviation 42.19
|
SECONDARY outcome
Timeframe: Weeks 1-5 (testing overall main effect of study group)Population: Results reflect the least squares means in each group across all 5 weeks of receipt data collection in the context of the repeated measures ANOVA model. In other words, results below can be thought of as average dollars spent by each study group over the course of the 5-week study.
Total dollars spent at the target grocery stores from submitted receipts
Outcome measures
| Measure |
Group 1 - Control
n=21 Participants
No intervention - participants will shop in-person as they usually would. Participants will receive recipe cards that follow the evidence-based DASH diet and correspond to dietary recommendations for diabetic patients.
|
Group 2 - Online
n=21 Participants
Participants will utilize online grocery shopping (shopping at a local grocery store via an online platform). Participants will also receive recipe cards that follow the evidence-based DASH diet and correspond to dietary recommendations for diabetic patients.
Online - use of online grocery shopping platform: The Online intervention will utilize online grocery shopping (shopping at a local grocery store via online platform).
|
Group 3 - Default
n=23 Participants
The default intervention will augment the Online intervention, showing participants a default cart when they log into their online grocery shopping accounts. They will be told that their cart has been filled with items that conform to a diabetic diet and can be used to make recipes from the provided recipe cards, and that they can modify it as they like. Participants will also receive recipe cards that follow the evidence-based DASH diet and correspond to dietary recommendations for diabetic patients.
Default - use of online grocery shopping platform with default shopping carts: The Defaults intervention, will augment the Online intervention, showing participants a default cart when they log into their online grocery shopping accounts. They will be told that their cart has been filled with items that conform to a diabetic diet and can be used to make the recipes from provided recipe cards, and that they may modify their cart as they like.
|
|---|---|---|---|
|
Dollars Spent
|
88.93 dollars
Standard Error 10.76
|
87.64 dollars
Standard Error 10.74
|
80.69 dollars
Standard Error 10.31
|
SECONDARY outcome
Timeframe: Baseline (week 1), intervention (weeks 2-4), and post-test (week 5)Population: The results below represent the change in dollars spent when purchasing groceries from target stores from week 1 to week 5 in each study group.
Changes in total dollars spent at the target grocery stores from submitted receipts
Outcome measures
| Measure |
Group 1 - Control
n=19 Participants
No intervention - participants will shop in-person as they usually would. Participants will receive recipe cards that follow the evidence-based DASH diet and correspond to dietary recommendations for diabetic patients.
|
Group 2 - Online
n=19 Participants
Participants will utilize online grocery shopping (shopping at a local grocery store via an online platform). Participants will also receive recipe cards that follow the evidence-based DASH diet and correspond to dietary recommendations for diabetic patients.
Online - use of online grocery shopping platform: The Online intervention will utilize online grocery shopping (shopping at a local grocery store via online platform).
|
Group 3 - Default
n=22 Participants
The default intervention will augment the Online intervention, showing participants a default cart when they log into their online grocery shopping accounts. They will be told that their cart has been filled with items that conform to a diabetic diet and can be used to make recipes from the provided recipe cards, and that they can modify it as they like. Participants will also receive recipe cards that follow the evidence-based DASH diet and correspond to dietary recommendations for diabetic patients.
Default - use of online grocery shopping platform with default shopping carts: The Defaults intervention, will augment the Online intervention, showing participants a default cart when they log into their online grocery shopping accounts. They will be told that their cart has been filled with items that conform to a diabetic diet and can be used to make the recipes from provided recipe cards, and that they may modify their cart as they like.
|
|---|---|---|---|
|
Change in Dollars Spent
|
-7.20 dollars
Standard Error 11.78
|
-8.65 dollars
Standard Error 11.76
|
-24.72 dollars
Standard Error 11.09
|
SECONDARY outcome
Timeframe: At post-test (week 5)Population: The total sample size of participants with usable food frequency questionnaire is 55 out of the 65 randomized participants. The outcome data provided is from the final intake model; least squares means are provided for each study group after adjusting for two covariates that warranted inclusion in the model, participant gender and income.
Nutritional quality of grocery purchases was created from food frequency questionnaire data using indicators adapted from Fung 2008: fruit, vegetables, nuts/legumes, whole grains, low-fat dairy, sodium, red/processed meat, carbohydrates. Quintiles were calculated for each, using reports of the frequency that the food group or nutrient of interest was consumed over the past month. Resulting scores from 1-5 indicate whether participants were lower or higher on each indicator (red meat, sodium, carbohydrates reverse scored). The 8 scores were summed for a total nutritional quality score ranging from 8 to 40 (40=highest nutritional quality).
Outcome measures
| Measure |
Group 1 - Control
n=18 Participants
No intervention - participants will shop in-person as they usually would. Participants will receive recipe cards that follow the evidence-based DASH diet and correspond to dietary recommendations for diabetic patients.
|
Group 2 - Online
n=18 Participants
Participants will utilize online grocery shopping (shopping at a local grocery store via an online platform). Participants will also receive recipe cards that follow the evidence-based DASH diet and correspond to dietary recommendations for diabetic patients.
Online - use of online grocery shopping platform: The Online intervention will utilize online grocery shopping (shopping at a local grocery store via online platform).
|
Group 3 - Default
n=19 Participants
The default intervention will augment the Online intervention, showing participants a default cart when they log into their online grocery shopping accounts. They will be told that their cart has been filled with items that conform to a diabetic diet and can be used to make recipes from the provided recipe cards, and that they can modify it as they like. Participants will also receive recipe cards that follow the evidence-based DASH diet and correspond to dietary recommendations for diabetic patients.
Default - use of online grocery shopping platform with default shopping carts: The Defaults intervention, will augment the Online intervention, showing participants a default cart when they log into their online grocery shopping accounts. They will be told that their cart has been filled with items that conform to a diabetic diet and can be used to make the recipes from provided recipe cards, and that they may modify their cart as they like.
|
|---|---|---|---|
|
Nutritional Quality of Foods Consumed
|
20.99 units on a scale
Standard Error 1.32
|
21.13 units on a scale
Standard Error 1.35
|
22.00 units on a scale
Standard Error 1.33
|
Adverse Events
Group 1 - Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 2 - Online
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 3 - Default
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place