Clinical trial NCT04178824: Multi-level Supermarket Discount Study
Official title: Multi-level Supermarket Discounts of Fruits and Vegetables' Impact on Intake and Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Nutrition
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2019-11-26
Enrollment: 167
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* BMI: 24.5 - 50
* Weight Stable (±5% body weight in last 3 mo)
* Accessible by telephone
* Living in NYC and not planning move
* Primary household food shopper
* ≥50% of food shopping at Foodtown/Brooklyn Harvest and agrees to 100% shopping at store during study
* Consumption of \>50% of food shopping
* Eat out or take out ≤5 times weekly

Exclusion Criteria:

* Pregnant or contemplating pregnancy
* Enrolled in related studies
* Active weight loss program
* Presence of serious medical (e.g. cancer, diabetes) or psychiatric disease (e.g. bipolar)
* Changes in medications or smoking in past 3 mo
* Excessive alcohol use (≥4 drinks/day) or illicit drug use
* Planning a vacation ≥ 4 consecutive weeks or 6 total weeks during study
* Receiving SNAP benefits

Primary outcomes:
measure: Fruit Intake as Assessed by 24-h Dietary Recalls
timeFrame: Week 8, 24, 40, 56
measure: Vegetable Intake as Assessed by 24-h Dietary Recalls
timeFrame: Week 8, 24, 40, 56
measure: Bottled Water Intake as Assessed by 24-h Dietary Recalls
timeFrame: Week 8, 24, 40, 56
measure: Seltzer Water Intake as Assessed by 24-h Dietary Recalls
timeFrame: Week 8, 24, 40, 56
measure: Diet Soda Intake as Assessed by 24-h Dietary Recalls
timeFrame: Week 8, 24, 40, 56
measure: Total Non-caloric Beverage Intake as Assessed by 24-h Dietary Recalls
timeFrame: Week 8, 24, 40, 56
Secondary outcomes:
measure: Body Weight
timeFrame: Week 0, 8, 24, 40, 56
measure: Body Mass Index (BMI)
timeFrame: Week 0, 8, 24, 40, 56
measure: Percent Body Fat
timeFrame: Week 0, 8, 24, 40, 56
measure: Waist Circumference
timeFrame: Week 0, 8, 24, 40, 56
measure: Fasting Glucose
timeFrame: Week 0, 8, 24, 40, 56
measure: Cholesterol Level
timeFrame: Week 0, 8, 24, 40, 56
measure: Blood Pressure
timeFrame: Week 0, 8, 24, 40, 56
measure: Gross Weekly Purchasing of Fruits and Vegetables
timeFrame: Week 8-56
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai St. Luke's
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Allan Geliebter, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.