Multi-level Supermarket Discount Study

Sponsor
Icahn School of Medicine at Mount Sinai (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04178824
Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)
312
1
3
73
4.3

Study Details

Study Description

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
  • Behavioral: Discount Intervention
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
312 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Multi-level Supermarket Discounts of Fruits and Vegetables' Impact on Intake and Health
Actual Study Start Date :
Sep 1, 2016
Anticipated Primary Completion Date :
Oct 1, 2022
Anticipated Study Completion Date :
Oct 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Individual consumption behaviors [Week 0]

    Fruit and vegetable intake as assessed by 24-h dietary recalls

  2. Individual consumption behaviors [Week 8]

    Fruit and vegetable intake as assessed by 24-h dietary recalls

  3. Individual consumption behaviors [Week 24]

    Fruit and vegetable intake as assessed by 24-h dietary recalls

  4. Individual consumption behaviors [Week 40]

    Fruit and vegetable intake as assessed by 24-h dietary recalls

  5. Individual consumption behaviors [Week 56]

    Fruit and vegetable intake as assessed by 24-h dietary recalls

Secondary Outcome Measures

  1. Body Weight [Week 0]

    Body weight (kg)

  2. Body Weight [Week 8]

    Body weight (kg)

  3. Body Weight [Week 24]

    Body weight (kg)

  4. Body Weight [Week 40]

    Body weight (kg)

  5. Body Weight [Week 56]

    Body weight (kg)

  6. Body Mass Index (BMI) [Week 0]

    BMI (kg/m2)

  7. Body Mass Index (BMI) [Week 8]

    BMI (kg/m2)

  8. Body Mass Index (BMI) [Week 24]

    BMI (kg/m2)

  9. Body Mass Index (BMI) [Week 40]

    BMI (kg/m2)

  10. Body Mass Index (BMI) [Week 56]

    BMI (kg/m2)

  11. Percent Body Fat [Week 56]

    % body fat

  12. Percent Body Fat [Week 0]

    % body fat

  13. Percent Body Fat [Week 8]

    % body fat

  14. Percent Body Fat [Week 24]

    % body fat

  15. Percent Body Fat [Week 40]

    % body fat

  16. Waist Circumference [Week 0]

    Waist circumference (cm) Metabolic risk factors (fasting glucose, cholesterol, blood pressure) and metabolic syndrome

  17. Waist Circumference [Week 8]

    Waist circumference (cm) Metabolic risk factors (fasting glucose, cholesterol, blood pressure) and metabolic syndrome

  18. Waist Circumference [Week 24]

    Waist circumference (cm) Metabolic risk factors (fasting glucose, cholesterol, blood pressure) and metabolic syndrome

  19. Waist Circumference [Week 40]

    Waist circumference (cm) Metabolic risk factors (fasting glucose, cholesterol, blood pressure) and metabolic syndrome

  20. Waist Circumference [Week 56]

    Waist circumference (cm) Metabolic risk factors (fasting glucose, cholesterol, blood pressure) and metabolic syndrome

  21. Fasting glucose [Week 0]

    Fasting glucose level

  22. Fasting glucose [Week 8]

    Fasting glucose level

  23. Fasting glucose [Week 24]

    Fasting glucose level

  24. Fasting glucose [Week 40]

    Fasting glucose level

  25. Fasting glucose [Week 56]

    Fasting glucose level

  26. Cholesterol Level [Week 0]

    Cholesterol level

  27. Cholesterol Level [Week 8]

    Cholesterol level

  28. Cholesterol Level [Week 24]

    Cholesterol level

  29. Cholesterol Level [Week 40]

    Cholesterol level

  30. Cholesterol Level [Week 56]

    Cholesterol level

  31. Blood Pressure [Week 0]

    Blood pressure (diastolic/systolic)

  32. Blood Pressure [Week 8]

    Blood pressure (diastolic/systolic)

  33. Blood Pressure [Week 24]

    Blood pressure (diastolic/systolic)

  34. Blood Pressure [Week 40]

    Blood pressure (diastolic/systolic)

  35. Blood Pressure [Week 56]

    Blood pressure (diastolic/systolic)

  36. Gross weekly purchasing of fruits and vegetables [Week 8-56]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
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:
  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mount Sinai St. Luke's New York New York United States 10025

Sponsors and Collaborators

  • Icahn School of Medicine at Mount Sinai
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

  • Principal Investigator: Allan Geliebter, PhD, Icahn School of Medicine at Mount Sinai

Study Documents (Full-Text)

None provided.

More Information

Publications

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
First Posted:
Nov 26, 2019
Last Update Posted:
Oct 21, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Allan Geliebter, Senior Scientist, Icahn School of Medicine at Mount Sinai

Study Results

No Results Posted as of Oct 21, 2021