NCT04178824

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
167

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Sep 2016

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

November 22, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 26, 2019

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2022

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

September 19, 2024

Completed
Last Updated

October 2, 2024

Status Verified

September 1, 2024

Enrollment Period

6.2 years

First QC Date

November 22, 2019

Results QC Date

July 15, 2024

Last Update Submit

September 6, 2024

Conditions

Keywords

Nutrition

Outcome Measures

Primary Outcomes (6)

  • 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

Secondary Outcomes (8)

  • Body Weight

    Week 0, 8, 24, 40, 56

  • Body Mass Index (BMI)

    Week 0, 8, 24, 40, 56

  • Percent Body Fat

    Week 0, 8, 24, 40, 56

  • Waist Circumference

    Week 0, 8, 24, 40, 56

  • Fasting Glucose

    Week 0, 8, 24, 40, 56

  • +3 more secondary outcomes

Study Arms (3)

Experimental 15% discount intervention

EXPERIMENTAL

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

Behavioral: Discount Intervention

Experimental 30% discount intervention

EXPERIMENTAL

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

Behavioral: Discount Intervention

No intervention control group

NO INTERVENTION

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

Interventions

15% or 30% discount on fruits and vegetables

Experimental 15% discount interventionExperimental 30% discount intervention

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mount Sinai St. Luke's

New York, New York, 10025, United States

Location

Related Publications (4)

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Allan Geliebter PhD
Organization
Icahn School of Medicine at Mount Sinai

Study Officials

  • Allan Geliebter, PhD

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Department of Psychiatry

Study Record Dates

First Submitted

November 22, 2019

First Posted

November 26, 2019

Study Start

September 1, 2016

Primary Completion

November 15, 2022

Study Completion

November 15, 2022

Last Updated

October 2, 2024

Results First Posted

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will share

The data will be made available upon request after study completion and publication.

Shared Documents
STUDY PROTOCOL, CSR
Time Frame
Data should become available 12/23
Access Criteria
Can be requested of the PI by other investigators.

Locations