- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04051008
CTSI Pilot: Improving Adherence to Diabetic Diet
CTSI Pilot: Improving Adherence to a Diabetic Diet With a Grocery Shopping Intervention
Study Overview
Status
Conditions
Detailed Description
The goal of this study is to test the effects of interventions informed by behavioral economics on the healthfulness of grocery purchases among diabetic adults. This study has a 3-group experimental design; adult patients with diabetes or at risk for diabetes who typically grocery shop in-person will be randomly assigned to one of two interventions or a control group. In all groups, recipe cards that follow the evidence-based DASH diet and correspond to dietary recommendations for diabetic patients will be provided. In addition, the first intervention, Online, will utilize online grocery shopping at a local grocery store to promote healthier purchasing, with a goal of removing visceral factors that can lead to impulse purchases in stores. The second intervention, Defaults, will augment the Online intervention, showing participants a default shopping cart when they log into their 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 the provided recipe cards, and that they may modify their carts as they like. In the control group, participants will shop in-person as usual.
At baseline, all participants will complete a survey online or via phone and then will grocery shop in-person as usual. Participants will then be randomized and receive further instructions. For the next 3 weeks, they will receive recipe cards and shop in accordance with their assigned study group. The following week (post), they will grocery shop using the mode of their choice (in-person or online) and complete a survey again. Household receipt data will be collected throughout the study. The baseline period will also serve as a run-in period, and participants whose diabetes/prediabetes status is not confirmed by a physician or who do not comply with study guidelines for baseline procedures will not be randomized for further participation. Primary analyses will examine intervention effects on grocery purchases, with additional analyses examining spending and dietary intake. All participant interactions will occur online or via phone, with cards for participant payment sent via postal mail.
The specific aims of this study are: (1) to test effects of Online and Defaults interventions on diabetic adults' grocery purchases and (2) to explore effects of the Online and Defaults interventions on participants' spending during grocery shopping. It is hypothesized that (1a) purchases made by adults in the Defaults group will be lower in calories, carbohydrates, and sugar and higher in nutritional quality (DASH diet score) at post-test versus other study groups, (1b) adults in the Defaults group will show the greatest increases in nutritional quality versus other study groups, (1c) the Online group will have intermediary results between Defaults and Controls, and (2) there will be no difference in total dollars depicted on receipts across study groups during the intervention period (i.e. the costs of online shopping will be offset by effects of the Online and Default interventions).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New York
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Buffalo, New York, United States, 14214
- State University of New York at Buffalo
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: 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.
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Experimental: 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.
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The Online intervention will utilize online grocery shopping (shopping at a local grocery store via online platform).
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Experimental: 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.
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Calories Purchased
Time Frame: At post-test (week 5)
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Receipt data will be entered into Nutritionist Pro software and will be used to calculate total calories purchased from target grocery stores.
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At post-test (week 5)
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Calories Purchased
Time Frame: Weeks 1-5 (testing overall main effect of study group)
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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.
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Weeks 1-5 (testing overall main effect of study group)
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Change in Calories Purchased
Time Frame: Baseline (week 1), intervention (weeks 2-4), and post-test (week 5)
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Receipt data will be entered into Nutritionist Pro and will be used to calculate changes in total calories purchased from target grocery stores.
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Baseline (week 1), intervention (weeks 2-4), and post-test (week 5)
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Carbohydrates Purchased
Time Frame: At post-test (week 5)
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Receipt data will be entered into Nutritionist Pro and will be used to calculate carbohydrates purchased from target grocery stores.
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At post-test (week 5)
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Carbohydrates Purchased
Time Frame: Weeks 1-5 (testing overall main effect of study group)
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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.
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Weeks 1-5 (testing overall main effect of study group)
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Change in Carbohydrates Purchased
Time Frame: Baseline (week 1), intervention (weeks 2-4), and post-test (week 5)
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Receipt data will be entered into Nutritionist Pro and will be used to calculate changes in carbohydrates purchased from target grocery stores.
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Baseline (week 1), intervention (weeks 2-4), and post-test (week 5)
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Sugars Purchased
Time Frame: At post-test (week 5)
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Receipt data will be entered into Nutritionist Pro and will be used to calculate sugars purchased from target grocery stores.
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At post-test (week 5)
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Sugars Purchased
Time Frame: Weeks 1-5 (testing overall main effect of study group)
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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.
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Weeks 1-5 (testing overall main effect of study group)
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Change in Sugars Purchased
Time Frame: Baseline (week 1), intervention (weeks 2-4), and post-test (week 5)
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Receipt data will be entered into Nutritionist Pro and will be used to calculate changes in sugars purchased from target grocery stores.
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Baseline (week 1), intervention (weeks 2-4), and post-test (week 5)
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Nutritional Quality of Purchases
Time Frame: At post-test (week 5)
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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).
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At post-test (week 5)
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Nutritional Quality of Purchases
Time Frame: Weeks 1-5 (testing overall main effect of study group)
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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).
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Weeks 1-5 (testing overall main effect of study group)
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Change in Nutritional Quality of Purchases
Time Frame: Baseline (week 1), intervention (weeks 2-4), and post-test (week 5)
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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)
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Baseline (week 1), intervention (weeks 2-4), and post-test (week 5)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dollars Spent
Time Frame: At post-test (week 5)
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Total dollars spent at the target grocery stores from submitted receipts
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At post-test (week 5)
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Dollars Spent
Time Frame: Weeks 1-5 (testing overall main effect of study group)
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Total dollars spent at the target grocery stores from submitted receipts
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Weeks 1-5 (testing overall main effect of study group)
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Change in Dollars Spent
Time Frame: Baseline (week 1), intervention (weeks 2-4), and post-test (week 5)
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Changes in total dollars spent at the target grocery stores from submitted receipts
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Baseline (week 1), intervention (weeks 2-4), and post-test (week 5)
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Nutritional Quality of Foods Consumed
Time Frame: At post-test (week 5)
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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).
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At post-test (week 5)
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Collaborators and Investigators
Investigators
- Principal Investigator: Stephanie Anzman Frasca, PhD, Associate Professor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00003054
- UL1TR001412 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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