Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Multi-level Supermarket Discount Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04178824
Recruitment Status : Recruiting
First Posted : November 26, 2019
Last Update Posted : July 30, 2020
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Allan Geliebter, Icahn School of Medicine at Mount Sinai

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.

Condition or disease Intervention/treatment Phase
Obesity Behavioral: Discount Intervention Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multi-level Supermarket Discounts of Fruits and Vegetables' Impact on Intake and Health
Actual Study Start Date : September 1, 2016
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : February 2022

Arm Intervention/treatment
Experimental: Experimental 15% discount intervention
15% discount on fruits, vegetables and non-caloric beverages at the designated supermarkets
Behavioral: Discount Intervention
15% or 30% discount on fruits and vegetables

Experimental: Experimental 30% discount intervention
30% discount on fruits, vegetables and non-caloric beverages at the designated supermarkets
Behavioral: Discount Intervention
15% or 30% discount on fruits and vegetables

No Intervention: No intervention control group
0% discount on fruits, vegetables and non-caloric beverages at the designated supermarkets



Primary Outcome Measures :
  1. Gross weekly purchasing of fruits and vegetables [ Time Frame: up to 32 weeks ]
    Gross weekly purchasing of fruits and vegetables from the discounted items list in dollars


Secondary Outcome Measures :
  1. Individual consumption behaviors [ Time Frame: Week 0 ]
    Fruit and vegetable intake as assessed by 24-h dietary recalls

  2. Individual consumption behaviors [ Time Frame: Week 8 ]
    Fruit and vegetable intake as assessed by 24-h dietary recalls

  3. Individual consumption behaviors [ Time Frame: Week 24 ]
    Fruit and vegetable intake as assessed by 24-h dietary recalls

  4. Individual consumption behaviors [ Time Frame: Week 40 ]
    Fruit and vegetable intake as assessed by 24-h dietary recalls

  5. Individual consumption behaviors [ Time Frame: Week 56 ]
    Fruit and vegetable intake as assessed by 24-h dietary recalls

  6. Body Weight [ Time Frame: Week 0 ]
    Body weight (kg)

  7. Body Weight [ Time Frame: Week 8 ]
    Body weight (kg)

  8. Body Weight [ Time Frame: Week 24 ]
    Body weight (kg)

  9. Body Weight [ Time Frame: Week 40 ]
    Body weight (kg)

  10. Body Weight [ Time Frame: Week 56 ]
    Body weight (kg)

  11. Body Mass Index (BMI) [ Time Frame: Week 0 ]
    BMI (kg/m2)

  12. Body Mass Index (BMI) [ Time Frame: Week 8 ]
    BMI (kg/m2)

  13. Body Mass Index (BMI) [ Time Frame: Week 24 ]
    BMI (kg/m2)

  14. Body Mass Index (BMI) [ Time Frame: Week 40 ]
    BMI (kg/m2)

  15. Body Mass Index (BMI) [ Time Frame: Week 56 ]
    BMI (kg/m2)

  16. Percent Body Fat [ Time Frame: Week 56 ]
    % body fat

  17. Percent Body Fat [ Time Frame: Week 0 ]
    % body fat

  18. Percent Body Fat [ Time Frame: Week 8 ]
    % body fat

  19. Percent Body Fat [ Time Frame: Week 24 ]
    % body fat

  20. Percent Body Fat [ Time Frame: Week 40 ]
    % body fat

  21. Waist Circumference [ Time Frame: Week 0 ]
    Waist circumference (cm) Metabolic risk factors (fasting glucose, cholesterol, blood pressure) and metabolic syndrome

  22. Waist Circumference [ Time Frame: Week 8 ]
    Waist circumference (cm) Metabolic risk factors (fasting glucose, cholesterol, blood pressure) and metabolic syndrome

  23. Waist Circumference [ Time Frame: Week 24 ]
    Waist circumference (cm) Metabolic risk factors (fasting glucose, cholesterol, blood pressure) and metabolic syndrome

  24. Waist Circumference [ Time Frame: Week 40 ]
    Waist circumference (cm) Metabolic risk factors (fasting glucose, cholesterol, blood pressure) and metabolic syndrome

  25. Waist Circumference [ Time Frame: Week 56 ]
    Waist circumference (cm) Metabolic risk factors (fasting glucose, cholesterol, blood pressure) and metabolic syndrome

  26. Fasting glucose [ Time Frame: Week 0 ]
    Fasting glucose level

  27. Fasting glucose [ Time Frame: Week 8 ]
    Fasting glucose level

  28. Fasting glucose [ Time Frame: Week 24 ]
    Fasting glucose level

  29. Fasting glucose [ Time Frame: Week 40 ]
    Fasting glucose level

  30. Fasting glucose [ Time Frame: Week 56 ]
    Fasting glucose level

  31. Cholesterol Level [ Time Frame: Week 0 ]
    Cholesterol level

  32. Cholesterol Level [ Time Frame: Week 8 ]
    Cholesterol level

  33. Cholesterol Level [ Time Frame: Week 24 ]
    Cholesterol level

  34. Cholesterol Level [ Time Frame: Week 40 ]
    Cholesterol level

  35. Cholesterol Level [ Time Frame: Week 56 ]
    Cholesterol level

  36. Blood Pressure [ Time Frame: Week 0 ]
    Blood pressure (diastolic/systolic)

  37. Blood Pressure [ Time Frame: Week 8 ]
    Blood pressure (diastolic/systolic)

  38. Blood Pressure [ Time Frame: Week 24 ]
    Blood pressure (diastolic/systolic)

  39. Blood Pressure [ Time Frame: Week 40 ]
    Blood pressure (diastolic/systolic)

  40. Blood Pressure [ Time Frame: Week 56 ]
    Blood pressure (diastolic/systolic)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04178824


Contacts
Layout table for location contacts
Contact: Allan Geliebter, PhD (212) 523 - 4184 allan.geliebter@mountsinai.org
Contact: Amanda Lister, MA (201) 233 - 4679 alister@mail.yu.edu

Locations
Layout table for location information
United States, New York
Mount Sinai St. Luke's Recruiting
New York, New York, United States, 10025
Contact: Shaunte Baboumian, MA    212-523-1718    shaunte.baboumian@mountsiani.org   
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Layout table for investigator information
Principal Investigator: Allan Geliebter, PhD Icahn School of Medicine at Mount Sinai
Publications:
Layout table for additonal information
Responsible Party: Allan Geliebter, Senior Scientist, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT04178824    
Other Study ID Numbers: GCO 16-1050
R01DK105440 ( U.S. NIH Grant/Contract )
First Posted: November 26, 2019    Key Record Dates
Last Update Posted: July 30, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The data will be made available upon request after study completion and publication.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Allan Geliebter, Icahn School of Medicine at Mount Sinai:
Nutrition