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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK105440 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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The study team's objective is to test the effect of supermarket discount levels on fruit and vegetable (F&V) and non-caloric beverage purchasing and consumption, as well as health outcomes. The study team will implement this economic intervention in a local supermarket chain to assess the effects of a 32-week intervention of fruit and vegetable (F&V) and non-caloric beverage discounts of 30%, 15%, and 0% (control group) on purchasing, dietary intake, and health outcomes, including body weight and composition, blood pressure, and biochemical markers of cardiovascular disease risk. The 32-week intervention will be preceded by an 8-week baseline and will have a follow-up period of 16 weeks. There will be no discounts in effect during the baseline and follow-up periods.
The objective is to test the effect of supermarket discount levels on fruit and vegetable (F&V) and non-caloric beverage purchasing and consumption, as well as health outcomes. The study team will implement this economic intervention in a local supermarket chain to assess the effects of a 32-week intervention of fruit and vegetable (F&V) and non-caloric beverage discounts of 30%, 15%, and 0% (control group) on purchasing, dietary intake, and health outcomes, including body weight and composition, blood pressure, and biochemical markers of cardiovascular disease risk. The prediction is that the impact will increase with the level of discount. The 32-week intervention will be preceded by an 8-week baseline and will have a follow-up period of 16 weeks. There will be no discounts in effect during the baseline and follow-up periods. The prediction is that some of the interventional effects will carry over to the follow-up period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental 15% discount intervention | Experimental | 15% discount on fruits, vegetables and non-caloric beverages at the designated supermarkets |
|
| Experimental 30% discount intervention | Experimental | 30% discount on fruits, vegetables and non-caloric beverages at the designated supermarkets |
|
| No intervention control group | No Intervention | 0% discount on fruits, vegetables and non-caloric beverages at the designated supermarkets |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Discount Intervention | Behavioral | 15% or 30% discount on fruits and vegetables |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fruit Intake as Assessed by 24-h Dietary Recalls | Individual consumption behaviors: Fruit intake as assessed by 24-h dietary recalls | Week 8, 24, 40, 56 |
| Vegetable Intake as Assessed by 24-h Dietary Recalls | Individual consumption behaviors: Vegetable intake as assessed by 24-h dietary recalls | Week 8, 24, 40, 56 |
| Bottled Water Intake as Assessed by 24-h Dietary Recalls | Individual consumption behaviors: bottled water intake as assessed by 24-h dietary recalls | Week 8, 24, 40, 56 |
| Seltzer Water Intake as Assessed by 24-h Dietary Recalls | Individual consumption behaviors: seltzer water intake as assessed by 24-h dietary recalls | Week 8, 24, 40, 56 |
| Diet Soda Intake as Assessed by 24-h Dietary Recalls | Individual consumption behaviors: diet soda intake as assessed by 24-h dietary recalls | Week 8, 24, 40, 56 |
| Total Non-caloric Beverage Intake as Assessed by 24-h Dietary Recalls | Individual consumption behaviors: Total non-caloric beverage intake as assessed by 24-h dietary recalls | Week 8, 24, 40, 56 |
| Measure | Description | Time Frame |
|---|---|---|
| Body Weight | Body weight (kg) | Week 0, 8, 24, 40, 56 |
| Body Mass Index (BMI) | BMI (kg/m^2) | Week 0, 8, 24, 40, 56 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Allan Geliebter, PhD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Sinai St. Luke's | New York | New York | 10025 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33667497 | Result | Poskute AS, Nzesi A, Geliebter A. Changes in food intake during the COVID-19 pandemic in New York City. Appetite. 2021 Aug 1;163:105191. doi: 10.1016/j.appet.2021.105191. Epub 2021 Mar 3. | |
| 35940334 | Result | Nzesi A, Roychowdhury L, De Jesus ML, Brown A, Geliebter A. Body weight, dietary intake, and health risk factors pre-COVID and during the COVID-19 pandemic. Appetite. 2022 Nov 1;178:106182. doi: 10.1016/j.appet.2022.106182. Epub 2022 Aug 6. |
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The data will be made available upon request after study completion and publication.
Data should become available 12/23
Can be requested of the PI by other investigators.
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental 15% Discount Intervention | 15% discount on fruits, vegetables and non-caloric beverages at the designated supermarkets |
| FG001 | Experimental 30% Discount Intervention | 30% discount on fruits, vegetables and non-caloric beverages at the designated supermarkets |
| FG002 | No Intervention Control Group | 0% discount on fruits, vegetables and non-caloric beverages at the designated supermarkets |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental 15% Discount Intervention | 15% discount on fruits, vegetables and non-caloric beverages at the designated supermarkets |
| BG001 | Experimental 30% Discount Intervention |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Fruit Intake as Assessed by 24-h Dietary Recalls | Individual consumption behaviors: Fruit intake as assessed by 24-h dietary recalls | Posted | Mean | 95% Confidence Interval | grams | Week 8, 24, 40, 56 |
|
56 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Experimental 15% Discount Intervention | 15% discount on fruits, vegetables and non-caloric beverages at the designated supermarkets |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Allan Geliebter PhD | Icahn School of Medicine at Mount Sinai | 212-523-4574 | Allan.Geliebter@mountsinai.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 13, 2024 | Jul 15, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 1, 2023 | Jul 15, 2024 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 1, 2022 | Jul 15, 2024 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| Percent Body Fat | % body fat | Week 0, 8, 24, 40, 56 |
| Waist Circumference | Waist circumference (cm) | Week 0, 8, 24, 40, 56 |
| Fasting Glucose | Fasting glucose level | Week 0, 8, 24, 40, 56 |
| Cholesterol Level | Cholesterol level | Week 0, 8, 24, 40, 56 |
| Blood Pressure | Blood pressure systolic and diastolic. | Week 0, 8, 24, 40, 56 |
| Gross Weekly Purchasing of Fruits and Vegetables | Gross weekly purchasing of fruits and vegetables from the discounted items list in dollars | Week 8-56 |
| 37992046 | Result | Nzesi A, Owusu B, Barry J, Sandhu M, Geliebter A. Impact of a randomized controlled trial of discounts on fruits, vegetables, and noncaloric beverages in NYC supermarkets on food intake and health risk factors. PLoS One. 2023 Nov 22;18(11):e0291770. doi: 10.1371/journal.pone.0291770. eCollection 2023. |
| 38932711 | Result | Poskute AS, Ang IYH, Rahman N, Geliebter A. Effects of discounting fruits, vegetables, and noncaloric beverages in New York City supermarkets on purchasing, intake, and weight. Obesity (Silver Spring). 2024 Jul;32(7):1290-1301. doi: 10.1002/oby.24058. |
30% discount on fruits, vegetables and non-caloric beverages at the designated supermarkets
| BG002 | No Intervention Control Group | 0% discount on fruits, vegetables and non-caloric beverages at the designated supermarkets |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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0% discount on fruits, vegetables and non-caloric beverages at the designated supermarkets |
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| Primary | Vegetable Intake as Assessed by 24-h Dietary Recalls | Individual consumption behaviors: Vegetable intake as assessed by 24-h dietary recalls | Posted | Mean | 95% Confidence Interval | grams | Week 8, 24, 40, 56 |
|
|
|
| Primary | Bottled Water Intake as Assessed by 24-h Dietary Recalls | Individual consumption behaviors: bottled water intake as assessed by 24-h dietary recalls | Posted | Mean | 95% Confidence Interval | grams | Week 8, 24, 40, 56 |
|
|
|
| Primary | Seltzer Water Intake as Assessed by 24-h Dietary Recalls | Individual consumption behaviors: seltzer water intake as assessed by 24-h dietary recalls | Posted | Mean | 95% Confidence Interval | grams | Week 8, 24, 40, 56 |
|
|
|
| Primary | Diet Soda Intake as Assessed by 24-h Dietary Recalls | Individual consumption behaviors: diet soda intake as assessed by 24-h dietary recalls | Posted | Mean | 95% Confidence Interval | grams | Week 8, 24, 40, 56 |
|
|
|
| Primary | Total Non-caloric Beverage Intake as Assessed by 24-h Dietary Recalls | Individual consumption behaviors: Total non-caloric beverage intake as assessed by 24-h dietary recalls | Posted | Mean | 95% Confidence Interval | grams | Week 8, 24, 40, 56 |
|
|
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| Secondary | Body Weight | Body weight (kg) | Posted | Mean | 95% Confidence Interval | kilograms | Week 0, 8, 24, 40, 56 |
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| Secondary | Body Mass Index (BMI) | BMI (kg/m^2) | Posted | Mean | 95% Confidence Interval | kg/m^2 | Week 0, 8, 24, 40, 56 |
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| Secondary | Percent Body Fat | % body fat | Posted | Mean | 95% Confidence Interval | percent of body fat | Week 0, 8, 24, 40, 56 |
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| Secondary | Waist Circumference | Waist circumference (cm) | Posted | Mean | 95% Confidence Interval | centimeters | Week 0, 8, 24, 40, 56 |
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| Secondary | Fasting Glucose | Fasting glucose level | Posted | Mean | 95% Confidence Interval | mg/dL | Week 0, 8, 24, 40, 56 |
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| Secondary | Cholesterol Level | Cholesterol level | Posted | Mean | 95% Confidence Interval | mg/dL | Week 0, 8, 24, 40, 56 |
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| Secondary | Blood Pressure | Blood pressure systolic and diastolic. | Posted | Mean | 95% Confidence Interval | mmHg | Week 0, 8, 24, 40, 56 |
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| Secondary | Gross Weekly Purchasing of Fruits and Vegetables | Gross weekly purchasing of fruits and vegetables from the discounted items list in dollars | Data was not collected as it was not received from vendor due to privacy concerns. | Posted | Week 8-56 |
|
|
| 0 |
| 38 |
| 0 |
| 38 |
| 0 |
| 38 |
| EG001 | Experimental 30% Discount Intervention | 30% discount on fruits, vegetables and non-caloric beverages at the designated supermarkets | 0 | 33 | 0 | 33 | 0 | 33 |
| EG002 | No Intervention Control Group | 0% discount on fruits, vegetables and non-caloric beverages at the designated supermarkets | 0 | 36 | 0 | 36 | 0 | 36 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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