Trial Outcomes & Findings for Multi-level Supermarket Discount Study (NCT NCT04178824)

NCT ID: NCT04178824

Last Updated: 2024-10-02

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 167 participants
• Primary outcome timeframe: Week 8, 24, 40, 56
• Results posted on: 2024-10-02

Participant Flow

Participant milestones

Measure	Experimental 15% Discount Intervention 15% discount on fruits, vegetables and non-caloric beverages at the designated supermarkets	Experimental 30% Discount Intervention 30% discount on fruits, vegetables and non-caloric beverages at the designated supermarkets	No Intervention Control Group 0% discount on fruits, vegetables and non-caloric beverages at the designated supermarkets
Overall Study STARTED	57	57	53
Overall Study COMPLETED	38	33	36
Overall Study NOT COMPLETED	19	24	17

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Multi-level Supermarket Discount Study

Baseline characteristics by cohort

Measure	Experimental 15% Discount Intervention n=38 Participants 15% discount on fruits, vegetables and non-caloric beverages at the designated supermarkets	Experimental 30% Discount Intervention n=33 Participants 30% discount on fruits, vegetables and non-caloric beverages at the designated supermarkets	No Intervention Control Group n=36 Participants 0% discount on fruits, vegetables and non-caloric beverages at the designated supermarkets	Total n=107 Participants Total of all reporting groups
Age, Continuous	40.0 years STANDARD_DEVIATION 12.9 • n=5 Participants	41.8 years STANDARD_DEVIATION 14.3 • n=7 Participants	39.6 years STANDARD_DEVIATION 11.7 • n=5 Participants	40.4 years STANDARD_DEVIATION 12.9 • n=4 Participants
Sex: Female, Male Female	24 Participants n=5 Participants	19 Participants n=7 Participants	24 Participants n=5 Participants	67 Participants n=4 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	14 Participants n=7 Participants	12 Participants n=5 Participants	40 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	8 Participants n=5 Participants	6 Participants n=7 Participants	6 Participants n=5 Participants	20 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	28 Participants n=5 Participants	25 Participants n=7 Participants	24 Participants n=5 Participants	77 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants	10 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	6 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Black or African American	11 Participants n=5 Participants	7 Participants n=7 Participants	17 Participants n=5 Participants	35 Participants n=4 Participants
Race (NIH/OMB) White	21 Participants n=5 Participants	15 Participants n=7 Participants	8 Participants n=5 Participants	44 Participants n=4 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	5 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	6 Participants n=7 Participants	6 Participants n=5 Participants	15 Participants n=4 Participants

PRIMARY outcome

Timeframe: Week 8, 24, 40, 56

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

Outcome measures

Measure	Experimental 15% Discount Intervention n=38 Participants 15% discount on fruits, vegetables and non-caloric beverages at the designated supermarkets	Experimental 30% Discount Intervention n=33 Participants 30% discount on fruits, vegetables and non-caloric beverages at the designated supermarkets	No Intervention Control Group n=36 Participants 0% discount on fruits, vegetables and non-caloric beverages at the designated supermarkets
Fruit Intake as Assessed by 24-h Dietary Recalls Week 8	99.6 grams Interval 57.1 to 142.0	112 grams Interval 66.6 to 157.0	93.4 grams Interval 49.6 to 137.0
Fruit Intake as Assessed by 24-h Dietary Recalls Week 24	127 grams Interval 84.5 to 169.0	120 grams Interval 75.3 to 166.0	112 grams Interval 67.8 to 155.0
Fruit Intake as Assessed by 24-h Dietary Recalls Week 40	105 grams Interval 60.0 to 149.0	137 grams Interval 90.5 to 183.0	86.8 grams Interval 40.4 to 133.0
Fruit Intake as Assessed by 24-h Dietary Recalls Week 56	198 grams Interval 149.0 to 248.0	124 grams Interval 76.5 to 171.0	54.9 grams Interval 3.35 to 106.0

PRIMARY outcome

Timeframe: Week 8, 24, 40, 56

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

Outcome measures

Measure	Experimental 15% Discount Intervention n=38 Participants 15% discount on fruits, vegetables and non-caloric beverages at the designated supermarkets	Experimental 30% Discount Intervention n=33 Participants 30% discount on fruits, vegetables and non-caloric beverages at the designated supermarkets	No Intervention Control Group n=36 Participants 0% discount on fruits, vegetables and non-caloric beverages at the designated supermarkets
Vegetable Intake as Assessed by 24-h Dietary Recalls Week 8	185 grams Interval 137.0 to 232.0	126 grams Interval 75.3 to 176.0	158 grams Interval 110.0 to 207.0
Vegetable Intake as Assessed by 24-h Dietary Recalls Week 24	190 grams Interval 143.0 to 237.0	192 grams Interval 142.0 to 242.0	136 grams Interval 87.6 to 185.0
Vegetable Intake as Assessed by 24-h Dietary Recalls Week 40	163 grams Interval 114.0 to 213.0	175 grams Interval 123.0 to 227.0	152 grams Interval 100.0 to 204.0
Vegetable Intake as Assessed by 24-h Dietary Recalls Week 56	137 grams Interval 81.4 to 193.0	157 grams Interval 104.0 to 210.0	176 grams Interval 119.0 to 234.0

PRIMARY outcome

Timeframe: Week 8, 24, 40, 56

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

Outcome measures

Measure	Experimental 15% Discount Intervention n=38 Participants 15% discount on fruits, vegetables and non-caloric beverages at the designated supermarkets	Experimental 30% Discount Intervention n=33 Participants 30% discount on fruits, vegetables and non-caloric beverages at the designated supermarkets	No Intervention Control Group n=36 Participants 0% discount on fruits, vegetables and non-caloric beverages at the designated supermarkets
Bottled Water Intake as Assessed by 24-h Dietary Recalls Week 8	93 grams Interval -47.9 to 234.0	178 grams Interval 28.5 to 328.0	132 grams Interval -13.2 to 277.0
Bottled Water Intake as Assessed by 24-h Dietary Recalls Week 24	137 grams Interval -2.55 to 276.0	156 grams Interval 6.59 to 306.0	190 grams Interval 44.8 to 334.0
Bottled Water Intake as Assessed by 24-h Dietary Recalls Week 40	217 grams Interval 69.3 to 365.0	202 grams Interval 48.6 to 355.0	272 grams Interval 118.0 to 427.0
Bottled Water Intake as Assessed by 24-h Dietary Recalls Week 56	179 grams Interval 13.3 to 345.0	86.8 grams Interval -70.9 to 244.0	264 grams Interval 91.5 to 437.0

PRIMARY outcome

Timeframe: Week 8, 24, 40, 56

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

Outcome measures

Measure	Experimental 15% Discount Intervention n=38 Participants 15% discount on fruits, vegetables and non-caloric beverages at the designated supermarkets	Experimental 30% Discount Intervention n=33 Participants 30% discount on fruits, vegetables and non-caloric beverages at the designated supermarkets	No Intervention Control Group n=36 Participants 0% discount on fruits, vegetables and non-caloric beverages at the designated supermarkets
Seltzer Water Intake as Assessed by 24-h Dietary Recalls Week 8	50.4 grams Interval -26.4 to 127.0	47.9 grams Interval -33.9 to 130.0	134 grams Interval 54.7 to 213.0
Seltzer Water Intake as Assessed by 24-h Dietary Recalls Week 24	64.4 grams Interval -11.8 to 141.0	65.2 grams Interval -16.6 to 147.0	157 grams Interval 78.2 to 236.0
Seltzer Water Intake as Assessed by 24-h Dietary Recalls Week 40	77.6 grams Interval -2.49 to 158.0	21.3 grams Interval -62.2 to 105.0	159 grams Interval 75.3 to 242.0
Seltzer Water Intake as Assessed by 24-h Dietary Recalls Week 56	61.6 grams Interval -26.9 to 150.0	84.8 grams Interval -0.702 to 170.0	182 grams Interval 90.0 to 274.0

PRIMARY outcome

Timeframe: Week 8, 24, 40, 56

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

Outcome measures

Measure	Experimental 15% Discount Intervention n=38 Participants 15% discount on fruits, vegetables and non-caloric beverages at the designated supermarkets	Experimental 30% Discount Intervention n=33 Participants 30% discount on fruits, vegetables and non-caloric beverages at the designated supermarkets	No Intervention Control Group n=36 Participants 0% discount on fruits, vegetables and non-caloric beverages at the designated supermarkets
Diet Soda Intake as Assessed by 24-h Dietary Recalls Week 8	1.89 grams Interval -35.5 to 39.3	33.6 grams Interval -6.34 to 73.6	37.5 grams Interval -1.0 to 75.9
Diet Soda Intake as Assessed by 24-h Dietary Recalls Week 24	12.5 grams Interval -24.8 to 49.7	78.9 grams Interval 38.9 to 119.0	15.1 grams Interval -23.3 to 53.6
Diet Soda Intake as Assessed by 24-h Dietary Recalls Week 40	4.19 grams Interval -34.1 to 42.4	57.5 grams Interval 17.1 to 98.0	18.9 grams Interval -20.7 to 58.5
Diet Soda Intake as Assessed by 24-h Dietary Recalls Week 56	13.2 grams Interval -27.1 to 53.6	69.1 grams Interval 28.2 to 110.0	16.3 grams Interval -25.5 to 58.0

PRIMARY outcome

Timeframe: Week 8, 24, 40, 56

Individual consumption behaviors: Total non-caloric beverage intake as assessed by 24-h dietary recalls

Outcome measures

Measure	Experimental 15% Discount Intervention n=38 Participants 15% discount on fruits, vegetables and non-caloric beverages at the designated supermarkets	Experimental 30% Discount Intervention n=33 Participants 30% discount on fruits, vegetables and non-caloric beverages at the designated supermarkets	No Intervention Control Group n=36 Participants 0% discount on fruits, vegetables and non-caloric beverages at the designated supermarkets
Total Non-caloric Beverage Intake as Assessed by 24-h Dietary Recalls Week 8	146 grams Interval -14.6 to 306.0	260 grams Interval 89.5 to 430.0	304 grams Interval 139.0 to 468.0
Total Non-caloric Beverage Intake as Assessed by 24-h Dietary Recalls Week 24	213 grams Interval 54.1 to 371.0	285 grams Interval 115.0 to 455.0	362 grams Interval 198.0 to 527.0
Total Non-caloric Beverage Intake as Assessed by 24-h Dietary Recalls Week 40	299 grams Interval 131.0 to 467.0	281 grams Interval 107.0 to 456.0	450 grams Interval 274.0 to 626.0
Total Non-caloric Beverage Intake as Assessed by 24-h Dietary Recalls Week 56	253 grams Interval 64.3 to 441.0	243 grams Interval 64.2 to 422.0	465 grams Interval 269.0 to 661.0

SECONDARY outcome

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

Body weight (kg)

Outcome measures

Measure	Experimental 15% Discount Intervention n=38 Participants 15% discount on fruits, vegetables and non-caloric beverages at the designated supermarkets	Experimental 30% Discount Intervention n=33 Participants 30% discount on fruits, vegetables and non-caloric beverages at the designated supermarkets	No Intervention Control Group n=36 Participants 0% discount on fruits, vegetables and non-caloric beverages at the designated supermarkets
Body Weight Week 40	84.2 kilograms Interval 78.5 to 89.8	83.9 kilograms Interval 77.8 to 89.9	84.6 kilograms Interval 78.8 to 90.5
Body Weight Week 56	86 kilograms Interval 80.3 to 91.6	83.4 kilograms Interval 77.4 to 89.5	84.3 kilograms Interval 78.5 to 90.1
Body Weight Week 0	84 kilograms Interval 78.4 to 89.7	83.5 kilograms Interval 77.5 to 89.5	83.3 kilograms Interval 77.5 to 89.1
Body Weight Week 8	84.3 kilograms Interval 78.6 to 89.9	82.8 kilograms Interval 76.8 to 88.8	84.6 kilograms Interval 78.8 to 90.4
Body Weight Week 24	84.4 kilograms Interval 78.8 to 90.0	83 kilograms Interval 77.0 to 89.0	85.2 kilograms Interval 79.4 to 91.0

SECONDARY outcome

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

BMI (kg/m^2)

Outcome measures

Measure	Experimental 15% Discount Intervention n=38 Participants 15% discount on fruits, vegetables and non-caloric beverages at the designated supermarkets	Experimental 30% Discount Intervention n=33 Participants 30% discount on fruits, vegetables and non-caloric beverages at the designated supermarkets	No Intervention Control Group n=36 Participants 0% discount on fruits, vegetables and non-caloric beverages at the designated supermarkets
Body Mass Index (BMI) Week 0	29.7 kg/m^2 Interval 27.8 to 31.5	29.7 kg/m^2 Interval 27.7 to 31.6	29.3 kg/m^2 Interval 27.4 to 31.2
Body Mass Index (BMI) Week 8	29.7 kg/m^2 Interval 27.8 to 31.5	29.5 kg/m^2 Interval 27.5 to 31.4	29.6 kg/m^2 Interval 27.8 to 31.5
Body Mass Index (BMI) Week 24	29.8 kg/m^2 Interval 28.0 to 31.6	29.1 kg/m^2 Interval 27.1 to 31.0	29.9 kg/m^2 Interval 28.1 to 31.8
Body Mass Index (BMI) Week 40	29.7 kg/m^2 Interval 27.9 to 31.6	29.8 kg/m^2 Interval 27.8 to 31.8	29.6 kg/m^2 Interval 27.7 to 31.5
Body Mass Index (BMI) Week 56	29.8 kg/m^2 Interval 27.9 to 31.6	29.6 kg/m^2 Interval 27.6 to 31.6	29.6 kg/m^2 Interval 27.7 to 31.6

SECONDARY outcome

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

% body fat

Outcome measures

Measure	Experimental 15% Discount Intervention n=38 Participants 15% discount on fruits, vegetables and non-caloric beverages at the designated supermarkets	Experimental 30% Discount Intervention n=33 Participants 30% discount on fruits, vegetables and non-caloric beverages at the designated supermarkets	No Intervention Control Group n=36 Participants 0% discount on fruits, vegetables and non-caloric beverages at the designated supermarkets
Percent Body Fat Week 8	33.5 percent of body fat Interval 30.1 to 36.8	32.6 percent of body fat Interval 29.0 to 36.2	33.3 percent of body fat Interval 29.9 to 36.7
Percent Body Fat Week 24	34 percent of body fat Interval 30.7 to 37.4	33 percent of body fat Interval 29.4 to 36.6	34.2 percent of body fat Interval 30.8 to 37.7
Percent Body Fat Week 40	34.1 percent of body fat Interval 30.7 to 37.5	33.8 percent of body fat Interval 30.2 to 37.4	34.4 percent of body fat Interval 30.9 to 37.9
Percent Body Fat Week 0	34 percent of body fat Interval 30.7 to 37.4	33.2 percent of body fat Interval 29.6 to 36.8	33.4 percent of body fat Interval 30.0 to 36.9
Percent Body Fat Week 56	34.2 percent of body fat Interval 30.8 to 37.6	33.5 percent of body fat Interval 29.9 to 37.1	34.2 percent of body fat Interval 30.7 to 37.7

SECONDARY outcome

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

Waist circumference (cm)

Outcome measures

Measure	Experimental 15% Discount Intervention n=38 Participants 15% discount on fruits, vegetables and non-caloric beverages at the designated supermarkets	Experimental 30% Discount Intervention n=33 Participants 30% discount on fruits, vegetables and non-caloric beverages at the designated supermarkets	No Intervention Control Group n=36 Participants 0% discount on fruits, vegetables and non-caloric beverages at the designated supermarkets
Waist Circumference Week 0	37.9 centimeters Interval 36.1 to 39.8	37.5 centimeters Interval 35.5 to 39.5	38.3 centimeters Interval 36.4 to 40.2
Waist Circumference Week 8	38.3 centimeters Interval 36.5 to 40.2	37.7 centimeters Interval 35.7 to 39.7	38.6 centimeters Interval 36.7 to 40.5
Waist Circumference Week 24	38 centimeters Interval 36.2 to 39.9	37.6 centimeters Interval 35.6 to 39.5	37.6 centimeters Interval 35.7 to 39.5
Waist Circumference Week 40	37.7 centimeters Interval 35.8 to 39.6	37.5 centimeters Interval 35.5 to 39.4	38.3 centimeters Interval 36.4 to 40.3
Waist Circumference Week 56	38 centimeters Interval 36.1 to 39.9	37.8 centimeters Interval 35.8 to 39.7	37.6 centimeters Interval 35.6 to 39.5

SECONDARY outcome

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

Fasting glucose level

Outcome measures

Measure	Experimental 15% Discount Intervention n=38 Participants 15% discount on fruits, vegetables and non-caloric beverages at the designated supermarkets	Experimental 30% Discount Intervention n=33 Participants 30% discount on fruits, vegetables and non-caloric beverages at the designated supermarkets	No Intervention Control Group n=36 Participants 0% discount on fruits, vegetables and non-caloric beverages at the designated supermarkets
Fasting Glucose Week 0	87.6 mg/dL Interval 83.8 to 91.5	87.4 mg/dL Interval 83.1 to 91.7	85 mg/dL Interval 80.9 to 89.2
Fasting Glucose Week 8	91.5 mg/dL Interval 87.6 to 95.4	91.5 mg/dL Interval 87.1 to 95.8	86.3 mg/dL Interval 82.3 to 90.3
Fasting Glucose Week 24	90.1 mg/dL Interval 86.0 to 94.1	93.1 mg/dL Interval 88.8 to 97.4	89.3 mg/dL Interval 85.0 to 93.7
Fasting Glucose Week 40	90.3 mg/dL Interval 85.3 to 95.3	89.7 mg/dL Interval 84.6 to 94.7	89.5 mg/dL Interval 84.7 to 94.4
Fasting Glucose Week 56	97.1 mg/dL Interval 92.0 to 102.0	96.9 mg/dL Interval 92.0 to 102.0	91.1 mg/dL Interval 85.8 to 96.3

SECONDARY outcome

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

Cholesterol level

Outcome measures

Measure	Experimental 15% Discount Intervention n=38 Participants 15% discount on fruits, vegetables and non-caloric beverages at the designated supermarkets	Experimental 30% Discount Intervention n=33 Participants 30% discount on fruits, vegetables and non-caloric beverages at the designated supermarkets	No Intervention Control Group n=36 Participants 0% discount on fruits, vegetables and non-caloric beverages at the designated supermarkets
Cholesterol Level Week 0	182 mg/dL Interval 171.0 to 192.0	184 mg/dL Interval 173.0 to 196.0	192 mg/dL Interval 181.0 to 203.0
Cholesterol Level Week 8	173 mg/dL Interval 162.0 to 183.0	183 mg/dL Interval 172.0 to 194.0	194 mg/dL Interval 183.0 to 204.0
Cholesterol Level Week 24	183 mg/dL Interval 172.0 to 193.0	183 mg/dL Interval 172.0 to 194.0	196 mg/dL Interval 185.0 to 207.0
Cholesterol Level Week 40	180 mg/dL Interval 169.0 to 192.0	180 mg/dL Interval 169.0 to 192.0	190 mg/dL Interval 179.0 to 202.0
Cholesterol Level Week 56	182 mg/dL Interval 171.0 to 193.0	188 mg/dL Interval 177.0 to 200.0	198 mg/dL Interval 187.0 to 210.0

SECONDARY outcome

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

Blood pressure systolic and diastolic.

Outcome measures

Measure	Experimental 15% Discount Intervention n=38 Participants 15% discount on fruits, vegetables and non-caloric beverages at the designated supermarkets	Experimental 30% Discount Intervention n=33 Participants 30% discount on fruits, vegetables and non-caloric beverages at the designated supermarkets	No Intervention Control Group n=36 Participants 0% discount on fruits, vegetables and non-caloric beverages at the designated supermarkets
Blood Pressure Week 0 systolic	121 mmHg Interval 116.0 to 125.0	117 mmHg Interval 112.0 to 122.0	122 mmHg Interval 117.0 to 127.0
Blood Pressure Week 0 diastolic	76.1 mmHg Interval 73.4 to 78.9	73 mmHg Interval 70.1 to 75.9	77.7 mmHg Interval 74.9 to 80.5
Blood Pressure Week 8 systolic	120 mmHg Interval 115.0 to 124.0	115 mmHg Interval 110.0 to 120.0	121 mmHg Interval 117.0 to 126.0
Blood Pressure Week 8 diastolic	75.6 mmHg Interval 72.9 to 78.3	72.4 mmHg Interval 69.4 to 75.4	78.3 mmHg Interval 75.5 to 81.1
Blood Pressure Week 24 systolic	119 mmHg Interval 114.0 to 123.0	116 mmHg Interval 111.0 to 121.0	121 mmHg Interval 116.0 to 126.0
Blood Pressure Week 24 diastolic	75 mmHg Interval 72.3 to 77.7	71.7 mmHg Interval 68.8 to 74.7	77.8 mmHg Interval 75.0 to 80.6
Blood Pressure Week 40 systolic	116 mmHg Interval 111.0 to 121.0	118 mmHg Interval 113.0 to 123.0	122 mmHg Interval 117.0 to 128.0
Blood Pressure Week 40 diastolic	75.1 mmHg Interval 71.9 to 78.2	75.1 mmHg Interval 72.0 to 78.2	75.2 mmHg Interval 71.9 to 78.4
Blood Pressure Week 56 systolic	115 mmHg Interval 110.0 to 121.0	117 mmHg Interval 112.0 to 123.0	120 mmHg Interval 114.0 to 126.0
Blood Pressure Week 56 diastolic	76 mmHg Interval 72.8 to 79.1	74.1 mmHg Interval 70.9 to 77.2	78.4 mmHg Interval 75.0 to 81.7

SECONDARY outcome

Timeframe: Week 8-56

Population: Data was not collected as it was not received from vendor due to privacy concerns.

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

Outcome measures

Outcome data not reported

Adverse Events

Experimental 15% Discount Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Experimental 30% Discount Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

No Intervention Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Allan Geliebter PhD

Icahn School of Medicine at Mount Sinai

Phone: 212-523-4574

Email: Allan.Geliebter@mountsinai.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place