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CompletedNCT04178824Updated Oct 2, 2024Results posted

Multi-level Supermarket Discount Study

An interventional study of Discount Intervention in Obesity, sponsored by Icahn School of Medicine at Mount Sinai. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-02.

Sponsored by Icahn School of Medicine at Mount Sinai · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 years 2 months after the study started (first participant enrolled Sep 2016, registered Nov 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
167
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Obesity

Keywords

  • Nutrition
03

In context

Lead sponsor

Icahn School of Medicine at Mount Sinai is the lead sponsor of 764 studies on the registry; 181 are open to participants now.

Of its 121 completed or terminated interventional studies of FDA-regulated products, 82 (68%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
167 participants (actual)

Study arms

  • Experimental
    Experimental 15% discount intervention

    15% discount on fruits, vegetables and non-caloric beverages at the designated supermarkets

    Behavioral: Discount Intervention

  • Experimental
    Experimental 30% discount intervention

    30% discount on fruits, vegetables and non-caloric beverages at the designated supermarkets

    Behavioral: Discount Intervention

  • No intervention
    No intervention control group

    0% discount on fruits, vegetables and non-caloric beverages at the designated supermarkets

Interventions

  • BehavioralDiscount Intervention

    15% or 30% discount on fruits and vegetables

06

What researchers measure

Primary outcomes

  1. Fruit Intake as Assessed by 24-h Dietary Recalls

    Individual consumption behaviors: Fruit intake as assessed by 24-h dietary recalls

    Time frame: Week 8, 24, 40, 56

  2. Vegetable Intake as Assessed by 24-h Dietary Recalls

    Individual consumption behaviors: Vegetable intake as assessed by 24-h dietary recalls

    Time frame: Week 8, 24, 40, 56

  3. Bottled Water Intake as Assessed by 24-h Dietary Recalls

    Individual consumption behaviors: bottled water intake as assessed by 24-h dietary recalls

    Time frame: Week 8, 24, 40, 56

  4. Seltzer Water Intake as Assessed by 24-h Dietary Recalls

    Individual consumption behaviors: seltzer water intake as assessed by 24-h dietary recalls

    Time frame: Week 8, 24, 40, 56

  5. Diet Soda Intake as Assessed by 24-h Dietary Recalls

    Individual consumption behaviors: diet soda intake as assessed by 24-h dietary recalls

    Time frame: Week 8, 24, 40, 56

  6. 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

    Time frame: Week 8, 24, 40, 56

Secondary outcomes

  1. Body Weight

    Body weight (kg)

    Time frame: Week 0, 8, 24, 40, 56

  2. Body Mass Index (BMI)

    BMI (kg/m\^2)

    Time frame: Week 0, 8, 24, 40, 56

  3. Percent Body Fat

    % body fat

    Time frame: Week 0, 8, 24, 40, 56

  4. Waist Circumference

    Waist circumference (cm)

    Time frame: Week 0, 8, 24, 40, 56

  5. Fasting Glucose

    Fasting glucose level

    Time frame: Week 0, 8, 24, 40, 56

  6. Cholesterol Level

    Cholesterol level

    Time frame: Week 0, 8, 24, 40, 56

  7. Blood Pressure

    Blood pressure systolic and diastolic.

    Time frame: Week 0, 8, 24, 40, 56

  8. Gross Weekly Purchasing of Fruits and Vegetables

    Gross weekly purchasing of fruits and vegetables from the discounted items list in dollars

    Time frame: Week 8-56

07

Results

Posted Sep 19, 2024

Participant flow

Participant flow — Overall Study
MilestoneExperimental 15% Discount InterventionExperimental 30% Discount InterventionNo Intervention Control Group
Started575753
Completed383336
Not completed192417

Outcome measures

PrimaryFruit Intake as Assessed by 24-h Dietary Recalls

Individual consumption behaviors: Fruit intake as assessed by 24-h dietary recalls

Time frame:
Week 8, 24, 40, 56
Reported as:
Mean · grams
Fruit Intake as Assessed by 24-h Dietary Recalls
gramsExperimental 15% Discount InterventionExperimental 30% Discount InterventionNo Intervention Control Group
Week 899.6 (57.1 to 142)112 (66.6 to 157)93.4 (49.6 to 137)
Week 24127 (84.5 to 169)120 (75.3 to 166)112 (67.8 to 155)
Week 40105 (60 to 149)137 (90.5 to 183)86.8 (40.4 to 133)
Week 56198 (149 to 248)124 (76.5 to 171)54.9 (3.35 to 106)
PrimaryVegetable Intake as Assessed by 24-h Dietary Recalls

Individual consumption behaviors: Vegetable intake as assessed by 24-h dietary recalls

Time frame:
Week 8, 24, 40, 56
Reported as:
Mean · grams
Vegetable Intake as Assessed by 24-h Dietary Recalls
gramsExperimental 15% Discount InterventionExperimental 30% Discount InterventionNo Intervention Control Group
Week 8185 (137 to 232)126 (75.3 to 176)158 (110 to 207)
Week 24190 (143 to 237)192 (142 to 242)136 (87.6 to 185)
Week 40163 (114 to 213)175 (123 to 227)152 (100 to 204)
Week 56137 (81.4 to 193)157 (104 to 210)176 (119 to 234)
PrimaryBottled Water Intake as Assessed by 24-h Dietary Recalls

Individual consumption behaviors: bottled water intake as assessed by 24-h dietary recalls

Time frame:
Week 8, 24, 40, 56
Reported as:
Mean · grams
Bottled Water Intake as Assessed by 24-h Dietary Recalls
gramsExperimental 15% Discount InterventionExperimental 30% Discount InterventionNo Intervention Control Group
Week 893 (-47.9 to 234)178 (28.5 to 328)132 (-13.2 to 277)
Week 24137 (-2.55 to 276)156 (6.59 to 306)190 (44.8 to 334)
Week 40217 (69.3 to 365)202 (48.6 to 355)272 (118 to 427)
Week 56179 (13.3 to 345)86.8 (-70.9 to 244)264 (91.5 to 437)
PrimarySeltzer Water Intake as Assessed by 24-h Dietary Recalls

Individual consumption behaviors: seltzer water intake as assessed by 24-h dietary recalls

Time frame:
Week 8, 24, 40, 56
Reported as:
Mean · grams
Seltzer Water Intake as Assessed by 24-h Dietary Recalls
gramsExperimental 15% Discount InterventionExperimental 30% Discount InterventionNo Intervention Control Group
Week 850.4 (-26.4 to 127)47.9 (-33.9 to 130)134 (54.7 to 213)
Week 2464.4 (-11.8 to 141)65.2 (-16.6 to 147)157 (78.2 to 236)
Week 4077.6 (-2.49 to 158)21.3 (-62.2 to 105)159 (75.3 to 242)
Week 5661.6 (-26.9 to 150)84.8 (-0.702 to 170)182 (90 to 274)
PrimaryDiet Soda Intake as Assessed by 24-h Dietary Recalls

Individual consumption behaviors: diet soda intake as assessed by 24-h dietary recalls

Time frame:
Week 8, 24, 40, 56
Reported as:
Mean · grams
Diet Soda Intake as Assessed by 24-h Dietary Recalls
gramsExperimental 15% Discount InterventionExperimental 30% Discount InterventionNo Intervention Control Group
Week 81.89 (-35.5 to 39.3)33.6 (-6.34 to 73.6)37.5 (-1 to 75.9)
Week 2412.5 (-24.8 to 49.7)78.9 (38.9 to 119)15.1 (-23.3 to 53.6)
Week 404.19 (-34.1 to 42.4)57.5 (17.1 to 98)18.9 (-20.7 to 58.5)
Week 5613.2 (-27.1 to 53.6)69.1 (28.2 to 110)16.3 (-25.5 to 58)
PrimaryTotal 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

Time frame:
Week 8, 24, 40, 56
Reported as:
Mean · grams
Total Non-caloric Beverage Intake as Assessed by 24-h Dietary Recalls
gramsExperimental 15% Discount InterventionExperimental 30% Discount InterventionNo Intervention Control Group
Week 8146 (-14.6 to 306)260 (89.5 to 430)304 (139 to 468)
Week 24213 (54.1 to 371)285 (115 to 455)362 (198 to 527)
Week 40299 (131 to 467)281 (107 to 456)450 (274 to 626)
Week 56253 (64.3 to 441)243 (64.2 to 422)465 (269 to 661)
SecondaryBody Weight

Body weight (kg)

Time frame:
Week 0, 8, 24, 40, 56
Reported as:
Mean · kilograms
Body Weight
kilogramsExperimental 15% Discount InterventionExperimental 30% Discount InterventionNo Intervention Control Group
Week 084 (78.4 to 89.7)83.5 (77.5 to 89.5)83.3 (77.5 to 89.1)
Week 884.3 (78.6 to 89.9)82.8 (76.8 to 88.8)84.6 (78.8 to 90.4)
Week 2484.4 (78.8 to 90)83 (77 to 89)85.2 (79.4 to 91)
Week 4084.2 (78.5 to 89.8)83.9 (77.8 to 89.9)84.6 (78.8 to 90.5)
Week 5686 (80.3 to 91.6)83.4 (77.4 to 89.5)84.3 (78.5 to 90.1)
SecondaryBody Mass Index (BMI)

BMI (kg/m\^2)

Time frame:
Week 0, 8, 24, 40, 56
Reported as:
Mean · kg/m^2
Body Mass Index (BMI)
kg/m^2Experimental 15% Discount InterventionExperimental 30% Discount InterventionNo Intervention Control Group
Week 029.7 (27.8 to 31.5)29.7 (27.7 to 31.6)29.3 (27.4 to 31.2)
Week 829.7 (27.8 to 31.5)29.5 (27.5 to 31.4)29.6 (27.8 to 31.5)
Week 2429.8 (28 to 31.6)29.1 (27.1 to 31)29.9 (28.1 to 31.8)
Week 4029.7 (27.9 to 31.6)29.8 (27.8 to 31.8)29.6 (27.7 to 31.5)
Week 5629.8 (27.9 to 31.6)29.6 (27.6 to 31.6)29.6 (27.7 to 31.6)
SecondaryPercent Body Fat

% body fat

Time frame:
Week 0, 8, 24, 40, 56
Reported as:
Mean · percent of body fat
Percent Body Fat
percent of body fatExperimental 15% Discount InterventionExperimental 30% Discount InterventionNo Intervention Control Group
Week 034 (30.7 to 37.4)33.2 (29.6 to 36.8)33.4 (30 to 36.9)
Week 833.5 (30.1 to 36.8)32.6 (29 to 36.2)33.3 (29.9 to 36.7)
Week 2434 (30.7 to 37.4)33 (29.4 to 36.6)34.2 (30.8 to 37.7)
Week 4034.1 (30.7 to 37.5)33.8 (30.2 to 37.4)34.4 (30.9 to 37.9)
Week 5634.2 (30.8 to 37.6)33.5 (29.9 to 37.1)34.2 (30.7 to 37.7)
SecondaryWaist Circumference

Waist circumference (cm)

Time frame:
Week 0, 8, 24, 40, 56
Reported as:
Mean · centimeters
Waist Circumference
centimetersExperimental 15% Discount InterventionExperimental 30% Discount InterventionNo Intervention Control Group
Week 037.9 (36.1 to 39.8)37.5 (35.5 to 39.5)38.3 (36.4 to 40.2)
Week 838.3 (36.5 to 40.2)37.7 (35.7 to 39.7)38.6 (36.7 to 40.5)
Week 2438 (36.2 to 39.9)37.6 (35.6 to 39.5)37.6 (35.7 to 39.5)
Week 4037.7 (35.8 to 39.6)37.5 (35.5 to 39.4)38.3 (36.4 to 40.3)
Week 5638 (36.1 to 39.9)37.8 (35.8 to 39.7)37.6 (35.6 to 39.5)
SecondaryFasting Glucose

Fasting glucose level

Time frame:
Week 0, 8, 24, 40, 56
Reported as:
Mean · mg/dL
Fasting Glucose
mg/dLExperimental 15% Discount InterventionExperimental 30% Discount InterventionNo Intervention Control Group
Week 087.6 (83.8 to 91.5)87.4 (83.1 to 91.7)85 (80.9 to 89.2)
Week 891.5 (87.6 to 95.4)91.5 (87.1 to 95.8)86.3 (82.3 to 90.3)
Week 2490.1 (86 to 94.1)93.1 (88.8 to 97.4)89.3 (85 to 93.7)
Week 4090.3 (85.3 to 95.3)89.7 (84.6 to 94.7)89.5 (84.7 to 94.4)
Week 5697.1 (92 to 102)96.9 (92 to 102)91.1 (85.8 to 96.3)
SecondaryCholesterol Level

Cholesterol level

Time frame:
Week 0, 8, 24, 40, 56
Reported as:
Mean · mg/dL
Cholesterol Level
mg/dLExperimental 15% Discount InterventionExperimental 30% Discount InterventionNo Intervention Control Group
Week 0182 (171 to 192)184 (173 to 196)192 (181 to 203)
Week 8173 (162 to 183)183 (172 to 194)194 (183 to 204)
Week 24183 (172 to 193)183 (172 to 194)196 (185 to 207)
Week 40180 (169 to 192)180 (169 to 192)190 (179 to 202)
Week 56182 (171 to 193)188 (177 to 200)198 (187 to 210)
SecondaryBlood Pressure

Blood pressure systolic and diastolic.

Time frame:
Week 0, 8, 24, 40, 56
Reported as:
Mean · mmHg
Blood Pressure
mmHgExperimental 15% Discount InterventionExperimental 30% Discount InterventionNo Intervention Control Group
Week 0 systolic121 (116 to 125)117 (112 to 122)122 (117 to 127)
Week 0 diastolic76.1 (73.4 to 78.9)73 (70.1 to 75.9)77.7 (74.9 to 80.5)
Week 8 systolic120 (115 to 124)115 (110 to 120)121 (117 to 126)
Week 8 diastolic75.6 (72.9 to 78.3)72.4 (69.4 to 75.4)78.3 (75.5 to 81.1)
Week 24 systolic119 (114 to 123)116 (111 to 121)121 (116 to 126)
Week 24 diastolic75 (72.3 to 77.7)71.7 (68.8 to 74.7)77.8 (75 to 80.6)
Week 40 systolic116 (111 to 121)118 (113 to 123)122 (117 to 128)
Week 40 diastolic75.1 (71.9 to 78.2)75.1 (72 to 78.2)75.2 (71.9 to 78.4)
Week 56 systolic115 (110 to 121)117 (112 to 123)120 (114 to 126)
Week 56 diastolic76 (72.8 to 79.1)74.1 (70.9 to 77.2)78.4 (75 to 81.7)
SecondaryGross Weekly Purchasing of Fruits and Vegetables

Gross weekly purchasing of fruits and vegetables from the discounted items list in dollars

Time frame:
Week 8-56

No measurements were reported for this outcome.

Adverse events

Collected over 56 weeks. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Experimental 15% Discount Intervention0/38 (0%)0/38 (0%)0/38 (0%)
Experimental 30% Discount Intervention0/33 (0%)0/33 (0%)0/33 (0%)
No Intervention Control Group0/36 (0%)0/36 (0%)0/36 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Experimental 15% Discount InterventionExperimental 30% Discount InterventionNo Intervention Control GroupTotal
Mean40.0 ± 12.941.8 ± 14.339.6 ± 11.740.4 ± 12.9
Sex: Female, Male
Sex: Female, Male(Participants)Experimental 15% Discount InterventionExperimental 30% Discount InterventionNo Intervention Control GroupTotal
Female24192467
Male14141240
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Experimental 15% Discount InterventionExperimental 30% Discount InterventionNo Intervention Control GroupTotal
Hispanic or Latino86620
Not Hispanic or Latino28252477
Unknown or Not Reported22610
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Experimental 15% Discount InterventionExperimental 30% Discount InterventionNo Intervention Control GroupTotal
American Indian or Alaska Native0101
Asian1236
Native Hawaiian or Other Pacific Islander0011
Black or African American1171735
White2115844
More than one race2215
Unknown or Not Reported36615
08

Study locations

1 site
  • Mount Sinai St. Luke's
    New York, New York 10025, United States
09

References and documents

Publications

  • 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. PubMed 33667497 ↗
  • 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. PubMed 35940334 ↗
  • 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. PubMed 37992046 ↗
  • 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. PubMed 38932711 ↗

Study documents

  • Study protocol · May 13, 2024
  • Statistical analysis plan · Aug 1, 2023
  • Informed consent form · Aug 1, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — The data will be made available upon request after study completion and publication.

Supporting information: Study protocol, Csr

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 2, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04178824
Lead sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Responsible party
Allan Geliebter (Professor, Department of Psychiatry, Icahn School of Medicine at Mount Sinai) — Principal investigator
First posted
Nov 26, 2019
Start date
Sep 1, 2016
Primary completion
Nov 15, 2022
Completion
Nov 15, 2022
Results posted
Sep 19, 2024
Last update
Oct 2, 2024

Study contacts

Allan Geliebter, PhD
principal investigator · Icahn School of Medicine at Mount Sinai

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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