NCT04051008

CTSI Pilot: Improving Adherence to Diabetic Diet

Completed NA Results posted Last updated 13 December 2023

What this trial tests

NA trial testing Online - use of online grocery shopping platform in Diabetes Mellitus, Type 2 in 65 participants. Completed in 3 December 2020.

Timeline

14 October 2019

Primary endpoint
3 December 2020

3 December 2020

Quick facts

Lead sponsor	State University of New York at Buffalo
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	other
Enrollment	65
Start date	14 October 2019
Primary completion	3 December 2020
Estimated completion	3 December 2020
Sites	1 location across United States

Drugs / interventions tested

• Online - use of online grocery shopping platform
• Default - use of online grocery shopping platform with default shopping carts

Conditions studied

• Diabetes Mellitus, Type 2 — all drugs for Diabetes Mellitus, Type 2 →
• Diet, Healthy — all drugs for Diet, Healthy →
• Pre-diabetes — all drugs for Pre-diabetes →

Sponsor

State University of New York at Buffalo

Who can join

18 and older, any sex, with Diabetes Mellitus, Type 2 or Diet, Healthy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Calories Purchased Primary · At post-test (week 5)

Receipt data will be entered into Nutritionist Pro software and will be used to calculate total calories purchased from target grocery stores.

Group	Value	95% CI
Group 1 - Control	24443.30	± 14918.22
Group 2 - Online	25339.20	± 19069.60
Group 3 - Default	18527.35	± 15025.35

Calories Purchased Primary · Weeks 1-5 (testing overall main effect of study group)

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.

Group	Value	95% CI
Group 1 - Control	25768	± 14908.1
Group 2 - Online	23479	± 14870.5
Group 3 - Default	20236	± 14948.3

Change in Calories Purchased Primary · Baseline (week 1), intervention (weeks 2-4), and post-test (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.

Group	Value	95% CI
Group 1 - Control	-2661.91	± 4023.56
Group 2 - Online	-1533.34	± 4016.82
Group 3 - Default	-6892.76	± 3786.38

Carbohydrates Purchased Primary · 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.

Group	Value	95% CI
Group 1 - Control	3320.09	± 2231.52
Group 2 - Online	3153.88	± 2805.51
Group 3 - Default	2417.95	± 2056.82

Carbohydrates Purchased Primary · Weeks 1-5 (testing overall main effect of study group)

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.

Group	Value	95% CI
Group 1 - Control	3200.85	± 1961.80
Group 2 - Online	2760.89	± 1955.66
Group 3 - Default	2502.41	± 1968.88

Change in Carbohydrates Purchased Primary · Baseline (week 1), intervention (weeks 2-4), and post-test (week 5)

Receipt data will be entered into Nutritionist Pro and will be used to calculate changes in carbohydrates purchased from target grocery stores.

Group	Value	95% CI
Group 1 - Control	-102.78	± 621.18
Group 2 - Online	-119.84	± 620.36
Group 3 - Default	-575.67	± 588.96

Sugars Purchased Primary · 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.

Group	Value	95% CI
Group 1 - Control	1212.27	± 985.07
Group 2 - Online	1026.31	± 809.66
Group 3 - Default	1024.99	± 873.16

Sugars Purchased Primary · Weeks 1-5 (testing overall main effect of study group)

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.

Group	Value	95% CI
Group 1 - Control	1271.2	± 905.47
Group 2 - Online	1110.85	± 902.90
Group 3 - Default	1035.17	± 907.99

Change in Sugars Purchased Primary · Baseline (week 1), intervention (weeks 2-4), and post-test (week 5)

Receipt data will be entered into Nutritionist Pro and will be used to calculate changes in sugars purchased from target grocery stores.

Group	Value	95% CI
Group 1 - Control	-138.31	± 265.25
Group 2 - Online	-374.92	± 264.84
Group 3 - Default	-308.32	± 249.56

Nutritional Quality of Purchases Primary · 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 qualit

Group	Value	95% CI
Group 1 - Control	20.89	± 4.37
Group 2 - Online	20.42	± 3.22
Group 3 - Default	21.55	± 3.02

Nutritional Quality of Purchases Primary · Weeks 1-5 (testing overall main effect of study 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 qualit

Group	Value	95% CI
Group 1 - Control	20.95	± 2.55
Group 2 - Online	21.43	± 2.54
Group 3 - Default	23.86	± 2.56

Change in Nutritional Quality of Purchases Primary · Baseline (week 1), intervention (weeks 2-4), and 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 qualit

Group	Value	95% CI
Group 1 - Control	-1.47	± 1.13
Group 2 - Online	-2.04	± 1.13
Group 3 - Default	-1.39	± 1.06

Sponsor's own description

425 million adults live with diabetes worldwide, and the prevalence of Type 2 diabetes is rising. Dietary approaches are recommended for weight control and diabetes management, but modern environments, characterized by plentiful, unhealthy foods, pose challenges to selecting a healthy diet. Behavioral economics offers a framework for modifying the food environment to encourage individuals with diabetes to select low-calorie and low-sugar foods. The goal of this study is to test novel approaches informed by behavioral economics to promote healthier grocery shopping among diabetic patients. Adults who have Type 2 diabetes or who are at risk for developing Type 2 diabetes will be recruited. Participants will be randomly assigned to 1 of 2 interventions or a control group in which they will shop in-person as usual. The Online intervention will utilize online grocery shopping to promote healthier purchasing. The Defaults intervention will augment this intervention, showing participants a default shopping cart pre-filled with items that correspond to the DASH diet and diabetic diet goals, which they may modify as they like. Receipt data will be collected to quantify the alignment of purchases with diabetic diet goals before, during, and after interventions. Purchases lower in calories, carbohydrates, and sugar and higher in nutritional quality (DASH diet score) are expected in the Defaults group; the Online group is expected to have intermediary results between Defaults and Controls. The investigators will also explore effects of the interventions on spending and dietary intake. This study is intended to demonstrate the efficacy of strategies that leverage behavioral economics principles to make the purchasing of healthier foods easier. The strategies have translational significance as they could be incorporated into clinical treatment, with the potential to improve dietary intake, glucose regulation, weight, and medication needs among diabetic patients.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Feasibility and implementation of a grocery shopping intervention for adults diagnosed with or at-risk for type 2 diabetes.
   Hollis-Hansen K, Tan S, Bargnesi S, McGovern L, et al · · 2023 · cited 2× · PMID 37496394 · DOI 10.1017/s1368980023001453