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CTSI Pilot: Improving Adherence to Diabetic Diet

Primary Purpose

Diabetes Mellitus, Type 2, Diet, Healthy, Pre-diabetes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Online - use of online grocery shopping platform
Default - use of online grocery shopping platform with default shopping carts
Sponsored by
State University of New York at Buffalo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Diabetes Mellitus, Type 2 focused on measuring grocery shopping, online shopping, diabetes, behavioral economics, diet

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • State University of New York at Buffalo

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Group 1 - Control

Group 2 - Online

Group 3 - Default

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Calories purchased
Receipt data will be entered into Nutritionist Pro software and will be used to calculate total calories purchased from target grocery stores.
Calories purchased
Receipt data will be entered into Nutritionist Pro software and will be used to calculate total calories purchased from target grocery stores.
Change in calories purchased
Receipt data will be entered into Nutritionist Pro and will be used to calculate changes in total calories purchased from target grocery stores.
Carbohydrates purchased
Receipt data will be entered into Nutritionist Pro and will be used to calculate carbohydrates purchased from target grocery stores.
Carbohydrates purchased
Receipt data will be entered into Nutritionist Pro and will be used to calculate carbohydrates purchased from target grocery stores.
Change in carbohydrates purchased
Receipt data will be entered into Nutritionist Pro and will be used to calculate changes in carbohydrates purchased from target grocery stores.
Sugars purchased
Receipt data will be entered into Nutritionist Pro and will be used to calculate sugars purchased from target grocery stores.
Sugars purchased
Receipt data will be entered into Nutritionist Pro and will be used to calculate sugars purchased from target grocery stores.
Change in sugars purchased
Receipt data will be entered into Nutritionist Pro and will be used to calculate changes in sugars purchased from target grocery stores.
Nutritional quality of purchases
Receipt data will be entered into Nutritionist Pro and will be used to quantify the nutritional quality of foods purchased from target grocery stores using Dietary Approaches to Stop Hypertension (DASH) diet scores adapted from prior research. These scores operationalize the extent to which the groceries purchased correspond to food groups that are promoted vs. limited in the DASH diet, with higher scores indicating healthier purchases.
Nutritional quality of purchases
Receipt data will be entered into Nutritionist Pro and will be used to quantify the nutritional quality of foods purchased from target grocery stores using DASH diet scores adapted from prior research. These scores operationalize the extent to which the groceries purchased correspond to food groups that are promoted vs. limited in the DASH diet, with higher scores indicating healthier purchases.
Change in nutritional quality of purchases
Receipt data will be entered into Nutritionist Pro and will be used to quantify the change in nutritional quality of foods purchased from target grocery stores using DASH diet scores adapted from prior research. These scores operationalize the extent to which the groceries purchased correspond to food groups that are promoted vs. limited in the DASH diet, with higher scores indicating healthier purchases.

Secondary Outcome Measures

Dollars spent
Total dollars spent at the target grocery stores from submitted receipts
Dollars spent
Total dollars spent at the target grocery stores from submitted receipts
Change in dollars spent
Changes in total dollars spent at the target grocery stores from submitted receipts
Nutritional quality of foods consumed
Data from Food Frequency Questionnaires. Dietary Approaches to Stop Hypertension (DASH) diet scores will be calculated. A higher score indicates greater adherence to DASH diet recommendations and nutritional quality of diet (anticipated range of total sum scores: 8-40).

Full Information

First Posted
July 31, 2019
Last Updated
December 22, 2020
Sponsor
State University of New York at Buffalo
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1. Study Identification

Unique Protocol Identification Number
NCT04051008
Brief Title
CTSI Pilot: Improving Adherence to Diabetic Diet
Official Title
CTSI Pilot: Improving Adherence to a Diabetic Diet With a Grocery Shopping Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
October 14, 2019 (Actual)
Primary Completion Date
December 3, 2020 (Actual)
Study Completion Date
December 3, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
State University of New York at Buffalo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Diet, Healthy, Pre-diabetes
Keywords
grocery shopping, online shopping, diabetes, behavioral economics, diet

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1 - Control
Arm Type
No Intervention
Arm Description
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.
Arm Title
Group 2 - Online
Arm Type
Experimental
Arm Description
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.
Arm Title
Group 3 - Default
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Online - use of online grocery shopping platform
Intervention Description
The Online intervention will utilize online grocery shopping (shopping at a local grocery store via online platform).
Intervention Type
Behavioral
Intervention Name(s)
Default - use of online grocery shopping platform with default shopping carts
Intervention Description
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.
Primary Outcome Measure Information:
Title
Calories purchased
Description
Receipt data will be entered into Nutritionist Pro software and will be used to calculate total calories purchased from target grocery stores.
Time Frame
At post-test (week 5)
Title
Calories purchased
Description
Receipt data will be entered into Nutritionist Pro software and will be used to calculate total calories purchased from target grocery stores.
Time Frame
Weeks 1-5 (testing overall main effect of study group)
Title
Change in calories purchased
Description
Receipt data will be entered into Nutritionist Pro and will be used to calculate changes in total calories purchased from target grocery stores.
Time Frame
Baseline (week 1), intervention (weeks 2-4), and post-test (week 5)
Title
Carbohydrates purchased
Description
Receipt data will be entered into Nutritionist Pro and will be used to calculate carbohydrates purchased from target grocery stores.
Time Frame
At post-test (week 5)
Title
Carbohydrates purchased
Description
Receipt data will be entered into Nutritionist Pro and will be used to calculate carbohydrates purchased from target grocery stores.
Time Frame
Weeks 1-5 (testing overall main effect of study group)
Title
Change in carbohydrates purchased
Description
Receipt data will be entered into Nutritionist Pro and will be used to calculate changes in carbohydrates purchased from target grocery stores.
Time Frame
Baseline (week 1), intervention (weeks 2-4), and post-test (week 5)
Title
Sugars purchased
Description
Receipt data will be entered into Nutritionist Pro and will be used to calculate sugars purchased from target grocery stores.
Time Frame
At post-test (week 5)
Title
Sugars purchased
Description
Receipt data will be entered into Nutritionist Pro and will be used to calculate sugars purchased from target grocery stores.
Time Frame
Weeks 1-5 (testing overall main effect of study group)
Title
Change in sugars purchased
Description
Receipt data will be entered into Nutritionist Pro and will be used to calculate changes in sugars purchased from target grocery stores.
Time Frame
Baseline (week 1), intervention (weeks 2-4), and post-test (week 5)
Title
Nutritional quality of purchases
Description
Receipt data will be entered into Nutritionist Pro and will be used to quantify the nutritional quality of foods purchased from target grocery stores using Dietary Approaches to Stop Hypertension (DASH) diet scores adapted from prior research. These scores operationalize the extent to which the groceries purchased correspond to food groups that are promoted vs. limited in the DASH diet, with higher scores indicating healthier purchases.
Time Frame
At post-test (week 5)
Title
Nutritional quality of purchases
Description
Receipt data will be entered into Nutritionist Pro and will be used to quantify the nutritional quality of foods purchased from target grocery stores using DASH diet scores adapted from prior research. These scores operationalize the extent to which the groceries purchased correspond to food groups that are promoted vs. limited in the DASH diet, with higher scores indicating healthier purchases.
Time Frame
Weeks 1-5 (testing overall main effect of study group)
Title
Change in nutritional quality of purchases
Description
Receipt data will be entered into Nutritionist Pro and will be used to quantify the change in nutritional quality of foods purchased from target grocery stores using DASH diet scores adapted from prior research. These scores operationalize the extent to which the groceries purchased correspond to food groups that are promoted vs. limited in the DASH diet, with higher scores indicating healthier purchases.
Time Frame
Baseline (week 1), intervention (weeks 2-4), and post-test (week 5)
Secondary Outcome Measure Information:
Title
Dollars spent
Description
Total dollars spent at the target grocery stores from submitted receipts
Time Frame
At post-test (week 5)
Title
Dollars spent
Description
Total dollars spent at the target grocery stores from submitted receipts
Time Frame
Weeks 1-5 (testing overall main effect of study group)
Title
Change in dollars spent
Description
Changes in total dollars spent at the target grocery stores from submitted receipts
Time Frame
Baseline (week 1), intervention (weeks 2-4), and post-test (week 5)
Title
Nutritional quality of foods consumed
Description
Data from Food Frequency Questionnaires. Dietary Approaches to Stop Hypertension (DASH) diet scores will be calculated. A higher score indicates greater adherence to DASH diet recommendations and nutritional quality of diet (anticipated range of total sum scores: 8-40).
Time Frame
At post-test (week 5)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephanie Anzman Frasca, PhD
Organizational Affiliation
Assistant Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
State University of New York at Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14214
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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CTSI Pilot: Improving Adherence to Diabetic Diet

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