Multi-level Supermarket Discount Study

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04178824
• Other study ID #: GCO 16-1050
• Secondary ID: R01DK105440
• Status: Completed
• Phase: N/A
• Start date: September 1, 2016
• Est. completion date: November 15, 2022

Study information

• Verified date: February 2023
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 312
• Est. completion date: November 15, 2022
• Est. primary completion date: November 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

Behavioral:
• Discount Intervention
15% or 30% discount on fruits and vegetables

Locations

Country	Name	City	State
United States	Mount Sinai St. Luke's	New York	New York

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

References & Publications (2)

Bernales-Korins M, Ang IYH, Khan S, Geliebter A. Psychosocial Influences on Fruit and Vegetable Intake Following a NYC Supermarket Discount. Obesity (Silver Spring). 2017 Aug;25(8):1321-1328. doi: 10.1002/oby.21876. Epub 2017 Jun 7. — View Citation

Geliebter A, Ang IYH, Bernales-Korins M, Hernandez D, Ochner CN, Ungredda T, Miller R, Kolbe L. Supermarket discounts of low-energy density foods: effects on purchasing, food intake, and body weight. Obesity (Silver Spring). 2013 Dec;21(12):E542-8. doi: 10.1002/oby.20484. Epub 2013 Jul 5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Individual consumption behaviors	Fruit and vegetable intake as assessed by 24-h dietary recalls	Week 0
Primary	Individual consumption behaviors	Fruit and vegetable intake as assessed by 24-h dietary recalls	Week 8
Primary	Individual consumption behaviors	Fruit and vegetable intake as assessed by 24-h dietary recalls	Week 24
Primary	Individual consumption behaviors	Fruit and vegetable intake as assessed by 24-h dietary recalls	Week 40
Primary	Individual consumption behaviors	Fruit and vegetable intake as assessed by 24-h dietary recalls	Week 56
Secondary	Body Weight	Body weight (kg)	Week 0
Secondary	Body Weight	Body weight (kg)	Week 8
Secondary	Body Weight	Body weight (kg)	Week 24
Secondary	Body Weight	Body weight (kg)	Week 40
Secondary	Body Weight	Body weight (kg)	Week 56
Secondary	Body Mass Index (BMI)	BMI (kg/m2)	Week 0
Secondary	Body Mass Index (BMI)	BMI (kg/m2)	Week 8
Secondary	Body Mass Index (BMI)	BMI (kg/m2)	Week 24
Secondary	Body Mass Index (BMI)	BMI (kg/m2)	Week 40
Secondary	Body Mass Index (BMI)	BMI (kg/m2)	Week 56
Secondary	Percent Body Fat	% body fat	Week 56
Secondary	Percent Body Fat	% body fat	Week 0
Secondary	Percent Body Fat	% body fat	Week 8
Secondary	Percent Body Fat	% body fat	Week 24
Secondary	Percent Body Fat	% body fat	Week 40
Secondary	Waist Circumference	Waist circumference (cm) Metabolic risk factors (fasting glucose, cholesterol, blood pressure) and metabolic syndrome	Week 0
Secondary	Waist Circumference	Waist circumference (cm) Metabolic risk factors (fasting glucose, cholesterol, blood pressure) and metabolic syndrome	Week 8
Secondary	Waist Circumference	Waist circumference (cm) Metabolic risk factors (fasting glucose, cholesterol, blood pressure) and metabolic syndrome	Week 24
Secondary	Waist Circumference	Waist circumference (cm) Metabolic risk factors (fasting glucose, cholesterol, blood pressure) and metabolic syndrome	Week 40
Secondary	Waist Circumference	Waist circumference (cm) Metabolic risk factors (fasting glucose, cholesterol, blood pressure) and metabolic syndrome	Week 56
Secondary	Fasting glucose	Fasting glucose level	Week 0
Secondary	Fasting glucose	Fasting glucose level	Week 8
Secondary	Fasting glucose	Fasting glucose level	Week 24
Secondary	Fasting glucose	Fasting glucose level	Week 40
Secondary	Fasting glucose	Fasting glucose level	Week 56
Secondary	Cholesterol Level	Cholesterol level	Week 0
Secondary	Cholesterol Level	Cholesterol level	Week 8
Secondary	Cholesterol Level	Cholesterol level	Week 24
Secondary	Cholesterol Level	Cholesterol level	Week 40
Secondary	Cholesterol Level	Cholesterol level	Week 56
Secondary	Blood Pressure	Blood pressure (diastolic/systolic)	Week 0
Secondary	Blood Pressure	Blood pressure (diastolic/systolic)	Week 8
Secondary	Blood Pressure	Blood pressure (diastolic/systolic)	Week 24
Secondary	Blood Pressure	Blood pressure (diastolic/systolic)	Week 40
Secondary	Blood Pressure	Blood pressure (diastolic/systolic)	Week 56
Secondary	Gross weekly purchasing of fruits and vegetables	Gross weekly purchasing of fruits and vegetables from the discounted items list in dollars	Week 8-56