N/A
N=65
CTSI Pilot: Improving Adherence to Diabetic Diet
Diabetes Mellitus, Type 2 · Diet, Healthy · Pre-diabetes
Bottom Line
View on ClinicalTrials.gov: NCT04051008 ↗Enrolled (actual)
65
Serious AEs
0.0%
Results posted
Dec 2023
Primary outcome: Primary: Calories Purchased — 24443.30; 25339.20; 18527.35 Kcal
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Online - use of online grocery shopping platform (Behavioral); Default - use of online grocery shopping platform with default shopping carts (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- State University of New York at Buffalo
- Primary completion
- Dec 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Calories Purchased |
25768; 23479; 20236 | — |
| PRIMARY Calories Purchased |
25768; 23479; 20236 | — |
| PRIMARY Change in Calories Purchased |
-2661.91; -1533.34; -6892.76 | — |
| PRIMARY Carbohydrates Purchased |
3200.85; 2760.89; 2502.41 | — |
| PRIMARY Carbohydrates Purchased |
3200.85; 2760.89; 2502.41 | — |
| PRIMARY Change in Carbohydrates Purchased |
-102.78; -119.84; -575.67 | — |
| PRIMARY Sugars Purchased |
1271.2; 1110.85; 1035.17 | — |
| PRIMARY Sugars Purchased |
1271.2; 1110.85; 1035.17 | — |
| PRIMARY Change in Sugars Purchased |
-138.31; -374.92; -308.32 | — |
| PRIMARY Nutritional Quality of Purchases |
20.95; 21.43; 23.86 | — |
| PRIMARY Nutritional Quality of Purchases |
20.95; 21.43; 23.86 | — |
| PRIMARY Change in Nutritional Quality of Purchases |
-1.47; -2.04; -1.39 | — |
| SECONDARY Dollars Spent |
88.93; 87.64; 80.69 | — |
| SECONDARY Dollars Spent |
88.93; 87.64; 80.69 | — |
| SECONDARY Change in Dollars Spent |
-7.20; -8.65; -24.72 | — |
| SECONDARY Nutritional Quality of Foods Consumed |
20.99; 21.13; 22.00 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Must be at least 18 years old
- Must have been diagnosed diabetes or demonstrate diabetes risk as defined by the American Diabetes Association
- Must shop in-person at select local grocery stores at least weekly, and at least 75% of the grocery shopping for the household must be done at these stores
- Must do at least 75% of the grocery shopping for the household
- Must speak English
Exclusion Criteria
- Is under 18 years of age
- Does not meet diabetes/risk for diabetes criteria
- Does not shop in-person at select local grocery stores at least weekly
- Does not live in a household in which 75% of groceries come from select local grocery stores
- Does not do at least 75% of the grocery shopping for the household
- Does not speak English
- Receives SNAP or WIC benefits (an exclusion criterion for this study due to incompatibility of EBT cards with the selected online grocery shopping platform at this time)
- Has dietary restrictions or preferences that would not allow them to reasonably partake in the study (i.e. they would not be willing or able to buy/eat many of the staple foods included in default carts/recipe cards)
Data sourced from ClinicalTrials.gov (NCT04051008). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.