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ObesityNCT04178824

Multi-level Supermarket Discount Study

A study testing Discount Intervention in people with Obesity, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Obesity
What is being tested?
Discount Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
167 participants
Where
1 siteUnited States
Study dates
1 Sep 2016to 15 Nov 2022
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 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Mount Sinai St. Luke's

    New York, New York, 10025

Other trials in United States

About this study

Official title: Multi-level Supermarket Discounts of Fruits and Vegetables' Impact on Intake and Health

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.

Conditions
Obesity
Being tested
Discount Intervention
Keywords
Nutrition
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Discount InterventionBehavioural

    15% or 30% discount on fruits and vegetables

Study groups in NCT04178824
Study groupRoleWhat they receive
Experimental 15% discount interventionExperimental15% discount on fruits, vegetables and non-caloric beverages at the designated supermarkets
Receives: Behavioral: Discount Intervention
Experimental 30% discount interventionExperimental30% discount on fruits, vegetables and non-caloric beverages at the designated supermarkets
Receives: Behavioral: Discount Intervention
No intervention control groupNo intervention0% discount on fruits, vegetables and non-caloric beverages at the designated supermarkets

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: Week 8, 24, 40, 56

Secondary outcomes (8)

  1. Body Weight

    Body weight (kg)

    Measured: Week 0, 8, 24, 40, 56

  2. Body Mass Index (BMI)

    BMI (kg/m^2)

    Measured: Week 0, 8, 24, 40, 56

  3. Percent Body Fat

    % body fat

    Measured: Week 0, 8, 24, 40, 56

  4. Waist Circumference

    Waist circumference (cm)

    Measured: Week 0, 8, 24, 40, 56

  5. Fasting Glucose

    Fasting glucose level

    Measured: Week 0, 8, 24, 40, 56

  6. Cholesterol Level

    Cholesterol level

    Measured: Week 0, 8, 24, 40, 56

  7. Blood Pressure

    Blood pressure systolic and diastolic.

    Measured: 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

    Measured: Week 8-56

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Nov 2019
  2. Study start1 Sep 2016
  3. Primary completion15 Nov 2022
  4. Study completion15 Nov 2022

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
167 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04178824
Sponsor's protocol ID
GCO 16-1050
Other IDs
R01DK105440
Status last verified
Sep 2024
First submitted
22 Nov 2019
Last updated
2 Oct 2024
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The data will be made available upon request after study completion and publication.

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

Questions about this trial

What is this clinical trial studying?

A study testing Discount Intervention in people with Obesity, run by Icahn School of Medicine at Mount Sinai 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 8 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 2 Oct 2024. 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 19 Sep 2024). 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?

Fruit Intake as Assessed by 24-h Dietary Recalls (time frame: Week 8, 24, 40, 56). The study lists 6 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 NCT04178824, which also lists 4 linked publications.

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 2 Oct 2024.

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