Diabetes Mellitus, Type 2NCT04051008
CTSI Pilot: Improving Adherence to Diabetic Diet
A study testing Online - use of online grocery shopping platform and Default - use of online grocery shopping platform with default shopping carts in people with Diabetes Mellitus, Type 2 and Diet, Healthy, run by State University of New York at Buffalo at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2, Diet, Healthy, Pre-diabetes
- What is being tested?
- Online - use of online grocery shopping platform and Default - use of online grocery shopping platform with default shopping carts
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Oct 2019to 3 Dec 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
State University of New York at Buffalo
Buffalo, New York, 14214
About this study
Official title: CTSI Pilot: Improving Adherence to a Diabetic Diet With a Grocery Shopping Intervention
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.
Read the 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).
- Conditions
- Diabetes Mellitus, Type 2, Diet, Healthy, Pre-diabetes
- Being tested
- Online - use of online grocery shopping platform, Default - use of online grocery shopping platform with default shopping carts
- Keywords
- grocery shopping, online shopping, diabetes, behavioral economics, diet
- Medical subject headings
- Diabetes Mellitus, Type 2, Glucose Intolerance, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online - use of online grocery shopping platformBehavioural
The Online intervention will utilize online grocery shopping (shopping at a local grocery store via online platform).
Default - use of online grocery shopping platform with default shopping cartsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - Control | No intervention | 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 | Experimental | 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. Receives: Behavioral: Online - use of online grocery shopping platform |
| Group 3 - Default | Experimental | 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. Receives: Behavioral: Default - use of online grocery shopping platform with default shopping carts |
What is being measured
The primary outcome is the main question the study is designed to answer.
Calories Purchased
Receipt data will be entered into Nutritionist Pro software and will be used to calculate total calories purchased from target grocery stores.
Measured: At post-test (week 5)
Calories Purchased
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.
Measured: Weeks 1-5 (testing overall main effect of study group)
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.
Measured: Baseline (week 1), intervention (weeks 2-4), and post-test (week 5)
Carbohydrates Purchased
Receipt data will be entered into Nutritionist Pro and will be used to calculate carbohydrates purchased from target grocery stores.
Measured: At post-test (week 5)
Carbohydrates Purchased
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.
Measured: Weeks 1-5 (testing overall main effect of study group)
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.
Measured: Baseline (week 1), intervention (weeks 2-4), and post-test (week 5)
Sugars Purchased
Receipt data will be entered into Nutritionist Pro and will be used to calculate sugars purchased from target grocery stores.
Measured: At post-test (week 5)
Sugars Purchased
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.
Measured: Weeks 1-5 (testing overall main effect of study group)
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.
Measured: Baseline (week 1), intervention (weeks 2-4), and post-test (week 5)
Nutritional Quality of Purchases
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).
Measured: At post-test (week 5)
Nutritional Quality of Purchases
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).
Measured: Weeks 1-5 (testing overall main effect of study group)
Change in Nutritional Quality of Purchases
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)
Measured: Baseline (week 1), intervention (weeks 2-4), and post-test (week 5)
Secondary outcomes (4)
Dollars Spent
Total dollars spent at the target grocery stores from submitted receipts
Measured: At post-test (week 5)
Dollars Spent
Total dollars spent at the target grocery stores from submitted receipts
Measured: Weeks 1-5 (testing overall main effect of study group)
Change in Dollars Spent
Changes in total dollars spent at the target grocery stores from submitted receipts
Measured: Baseline (week 1), intervention (weeks 2-4), and post-test (week 5)
Nutritional Quality of Foods Consumed
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).
Measured: At post-test (week 5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2019
- Study start14 Oct 2019
- Primary completion3 Dec 2020
- Study completion3 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Principal investigator, Stephanie Anzman-Frasca, State University of New York at Buffalo
- Investigators
- Stephanie Anzman Frasca, PhD, Principal investigator, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04051008
- Sponsor's protocol ID
- STUDY00003054
- Other IDs
- UL1TR001412
- Status last verified
- Nov 2023
- First submitted
- 31 Jul 2019
- Last updated
- 13 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hollis-Hansen K, Tan S, Bargnesi S, McGovern L, Drozdowsky J, Epstein LH, Leone LA, Mak E, Masci J, Anzman-Frasca S. Feasibility and implementation of a grocery shopping intervention for adults diagnosed with or at-risk for type 2 diabetes. Public Health Nutr. 2023 Oct;26(10):2118-2129. doi: 10.1017/S1368980023001453. Epub 2023 Jul 27.
PubMed 37496394
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CTSI Pilot: Improving Adherence to a Diabetic Diet With a Grocery Shopping Intervention
- ClinicalTrials.gov ID
- NCT04051008
- Acronym / sponsor ID
- STUDY00003054
- Conditions
- Diabetes Mellitus, Type 2, Diet, Healthy, Pre-diabetes
- Keywords
- grocery shopping, online shopping, diabetes, behavioral economics, diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Study start
- 14 Oct 2019 (actual)
- Primary completion
- 3 Dec 2020 (actual)
- Study completion
- 3 Dec 2020 (actual)
- First posted
- 9 Aug 2019 (actual)
- Results
- Posted 13 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 - Control | No intervention | –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 | Experimental | Behavioral: Online - use of online grocery shopping platformParticipants 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. |
| Group 3 - Default | Experimental | Behavioral: Default - use of online grocery shopping platform with default shopping cartsThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online - use of online grocery shopping platformThe Online intervention will utilize online grocery shopping (shopping at a local grocery store via online platform). | Behavioural | Group 2 - Online |
| Default - use of online grocery shopping platform with default shopping cartsThe 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. | Behavioural | Group 3 - Default |
Primary outcome
Calories Purchased
Time frame: 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.
Calories Purchased
Time frame: 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.
Change in Calories Purchased
Time frame: 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.
Carbohydrates Purchased
Time frame: 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.
Carbohydrates Purchased
Time frame: 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.
Change in Carbohydrates Purchased
Time frame: 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.
Sugars Purchased
Time frame: 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.
Sugars Purchased
Time frame: 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.
Change in Sugars Purchased
Time frame: 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.
Nutritional Quality of Purchases
Time frame: 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).
Nutritional Quality of Purchases
Time frame: 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 quality).
Change in Nutritional Quality of Purchases
Time frame: 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 quality)
4 secondary outcomes
Dollars Spent
Time frame: At post-test (week 5)
Dollars Spent
Time frame: Weeks 1-5 (testing overall main effect of study group)
Change in Dollars Spent
Time frame: Baseline (week 1), intervention (weeks 2-4), and post-test (week 5)
Nutritional Quality of Foods Consumed
Time frame: At post-test (week 5)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37496394Hollis-Hansen K, Tan S, Bargnesi S, McGovern L, Drozdowsky J, Epstein LH, Leone LA, Mak E, Masci J, Anzman-Frasca S. Feasibility and implementation of a grocery shopping intervention for adults diagnosed with or at-risk for type 2 diabetes. Public Health Nutr. 2023 Oct;26(10):2118-2129. doi: 10.1017/S1368980023001453. Epub 2023 Jul 27.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephanie Anzman Frasca, PhD principal investigator
Associate Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online - use of online grocery shopping platform and Default - use of online grocery shopping platform with default shopping carts in people with Diabetes Mellitus, Type 2 and Diet, Healthy, run by State University of New York at Buffalo at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Calories Purchased (time frame: At post-test (week 5)). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04051008, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2023.