Trial Outcomes & Findings for Promoting Employee Health Through The Worksite Food Environment (NCT NCT02660086)

NCT ID: NCT02660086

Last Updated: 2021-12-01

Results Overview

Change in weight from baseline to 12 months

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

602 participants

Primary outcome timeframe

12 months

Results posted on

2021-12-01

Participant Flow

Participant milestones

Participant milestones
Measure
Personalized Feedback
Emails and letters providing personalized nutrition feedback about food choices and health, social norms, and financial incentives for healthy food choices Personalized nutrition feedback: Automated personalized nutrition feedback about cafeteria food purchases (weekly); social norms and small financial incentives to promote healthy purchases (monthly)
Control
Monthly letters with general nutrition information
Overall Study- 12-month
STARTED
299
303
Overall Study- 12-month
COMPLETED
273
274
Overall Study- 12-month
NOT COMPLETED
26
29
Overall Study: 24-month Follow-up
STARTED
281
278
Overall Study: 24-month Follow-up
COMPLETED
255
254
Overall Study: 24-month Follow-up
NOT COMPLETED
26
24

Reasons for withdrawal

Reasons for withdrawal
Measure
Personalized Feedback
Emails and letters providing personalized nutrition feedback about food choices and health, social norms, and financial incentives for healthy food choices Personalized nutrition feedback: Automated personalized nutrition feedback about cafeteria food purchases (weekly); social norms and small financial incentives to promote healthy purchases (monthly)
Control
Monthly letters with general nutrition information
Overall Study- 12-month
Withdrawal by Subject
5
5
Overall Study- 12-month
Left full-time employment
12
20
Overall Study- 12-month
Missed 12-month follow-up visit
8
4
Overall Study- 12-month
Became ineligible: new job in cafeteria
1
0
Overall Study: 24-month Follow-up
Left employment after 12 months
17
8
Overall Study: 24-month Follow-up
Missed 24-month follow-up
9
16

Baseline Characteristics

Promoting Employee Health Through The Worksite Food Environment

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Personalized Feedback
n=299 Participants
Emails and letters providing personalized nutrition feedback about food choices and health, social norms, and financial incentives for healthy food choices Personalized nutrition feedback: Automated personalized nutrition feedback about cafeteria food purchases (weekly); social norms and small financial incentives to promote healthy purchases (monthly)
Control
n=303 Participants
Monthly letters with general nutrition information
Total
n=602 Participants
Total of all reporting groups
Age, Continuous
43.5 years
STANDARD_DEVIATION 12.0 • n=5 Participants
43.8 years
STANDARD_DEVIATION 12.5 • n=7 Participants
43.6 years
STANDARD_DEVIATION 12.2 • n=5 Participants
Sex: Female, Male
Female
230 Participants
n=5 Participants
248 Participants
n=7 Participants
478 Participants
n=5 Participants
Sex: Female, Male
Male
69 Participants
n=5 Participants
55 Participants
n=7 Participants
124 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
17 Participants
n=5 Participants
17 Participants
n=7 Participants
34 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
282 Participants
n=5 Participants
286 Participants
n=7 Participants
568 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race/Ethnicity, Customized
White
246 Participants
n=5 Participants
242 Participants
n=7 Participants
488 Participants
n=5 Participants
Race/Ethnicity, Customized
Black
28 Participants
n=5 Participants
26 Participants
n=7 Participants
54 Participants
n=5 Participants
Race/Ethnicity, Customized
Asian
14 Participants
n=5 Participants
13 Participants
n=7 Participants
27 Participants
n=5 Participants
Race/Ethnicity, Customized
Other race or not reported
11 Participants
n=5 Participants
22 Participants
n=7 Participants
33 Participants
n=5 Participants
Region of Enrollment
United States
299 participants
n=5 Participants
303 participants
n=7 Participants
602 participants
n=5 Participants
Education
High school or some college
36 Participants
n=5 Participants
39 Participants
n=7 Participants
75 Participants
n=5 Participants
Education
College degree
123 Participants
n=5 Participants
117 Participants
n=7 Participants
240 Participants
n=5 Participants
Education
Graduate degree
138 Participants
n=5 Participants
146 Participants
n=7 Participants
284 Participants
n=5 Participants
Education
Not reported
2 Participants
n=5 Participants
1 Participants
n=7 Participants
3 Participants
n=5 Participants
Job category
Administrative or service
36 Participants
n=5 Participants
48 Participants
n=7 Participants
84 Participants
n=5 Participants
Job category
Crafts or technicians
36 Participants
n=5 Participants
31 Participants
n=7 Participants
67 Participants
n=5 Participants
Job category
Management or professionals
193 Participants
n=5 Participants
184 Participants
n=7 Participants
377 Participants
n=5 Participants
Job category
Physicians or PhDs
34 Participants
n=5 Participants
40 Participants
n=7 Participants
74 Participants
n=5 Participants
Weight
79.8 kg
STANDARD_DEVIATION 18.8 • n=5 Participants
77.0 kg
STANDARD_DEVIATION 18.3 • n=7 Participants
78.4 kg
STANDARD_DEVIATION 18.6 • n=5 Participants
Weight category
Normal weight (BMI <25)
109 Participants
n=5 Participants
119 Participants
n=7 Participants
228 Participants
n=5 Participants
Weight category
Overweight (BMI 25-29.9)
92 Participants
n=5 Participants
100 Participants
n=7 Participants
192 Participants
n=5 Participants
Weight category
Obese (BMI >=30)
98 Participants
n=5 Participants
84 Participants
n=7 Participants
182 Participants
n=5 Participants
Body Mass Index (BMI)
28.6 kg/m^2
STANDARD_DEVIATION 6.6 • n=5 Participants
27.9 kg/m^2
STANDARD_DEVIATION 6.4 • n=7 Participants
28.3 kg/m^2
STANDARD_DEVIATION 6.5 • n=5 Participants
Systolic blood pressure
121.4 mmHg
STANDARD_DEVIATION 14.4 • n=5 Participants
120.4 mmHg
STANDARD_DEVIATION 14.7 • n=7 Participants
120.9 mmHg
STANDARD_DEVIATION 14.5 • n=5 Participants
Diastolic blood pressure
71.3 mmHg
STANDARD_DEVIATION 9.9 • n=5 Participants
70.2 mmHg
STANDARD_DEVIATION 9.9 • n=7 Participants
70.7 mmHg
STANDARD_DEVIATION 9.9 • n=5 Participants
Total cholesterol
183.8 mg/dL
STANDARD_DEVIATION 34.8 • n=5 Participants
182.7 mg/dL
STANDARD_DEVIATION 38.2 • n=7 Participants
183.2 mg/dL
STANDARD_DEVIATION 36.5 • n=5 Participants
LDL cholesterol
102.1 mg/dL
STANDARD_DEVIATION 30.6 • n=5 Participants
101.5 mg/dL
STANDARD_DEVIATION 33.2 • n=7 Participants
101.8 mg/dL
STANDARD_DEVIATION 31.9 • n=5 Participants
HDL cholesterol
63.0 mg/dL
STANDARD_DEVIATION 18.5 • n=5 Participants
62.1 mg/dL
STANDARD_DEVIATION 17.4 • n=7 Participants
62.5 mg/dL
STANDARD_DEVIATION 17.9 • n=5 Participants
Triglycerides
94.5 mg/dL
STANDARD_DEVIATION 56.3 • n=5 Participants
94.5 mg/dL
STANDARD_DEVIATION 67.0 • n=7 Participants
94.5 mg/dL
STANDARD_DEVIATION 61.9 • n=5 Participants
Hemoglobin A1C
5.5 percent
STANDARD_DEVIATION 0.5 • n=5 Participants
5.5 percent
STANDARD_DEVIATION 0.6 • n=7 Participants
5.5 percent
STANDARD_DEVIATION 0.6 • n=5 Participants
Percentage green-labeled (healthy) food purchased
50.1 percent
STANDARD_DEVIATION 16.3 • n=5 Participants
52.3 percent
STANDARD_DEVIATION 17.1 • n=7 Participants
51.2 percent
STANDARD_DEVIATION 16.7 • n=5 Participants
Percentage yellow-labeled food purchased
34.2 percent
STANDARD_DEVIATION 11.8 • n=5 Participants
33.1 percent
STANDARD_DEVIATION 11.9 • n=7 Participants
33.6 percent
STANDARD_DEVIATION 11.9 • n=5 Participants
Percentage red-labeled food purchased
15.7 percent
STANDARD_DEVIATION 10.8 • n=5 Participants
14.6 percent
STANDARD_DEVIATION 10.9 • n=7 Participants
15.1 percent
STANDARD_DEVIATION 10.9 • n=5 Participants
Healthy purchasing score
67.2 units on a scale from 0-100
STANDARD_DEVIATION 12.5 • n=5 Participants
68.8 units on a scale from 0-100
STANDARD_DEVIATION 13.1 • n=7 Participants
68.0 units on a scale from 0-100
STANDARD_DEVIATION 12.8 • n=5 Participants
Healthy Eating Index Score
59.7 units on a scale from 0-100
STANDARD_DEVIATION 12.3 • n=5 Participants
61.0 units on a scale from 0-100
STANDARD_DEVIATION 12.5 • n=7 Participants
60.4 units on a scale from 0-100
STANDARD_DEVIATION 12.4 • n=5 Participants
Hypertension
Hypertension
51 Participants
n=5 Participants
49 Participants
n=7 Participants
100 Participants
n=5 Participants
Hypertension
No hypertension
248 Participants
n=5 Participants
254 Participants
n=7 Participants
502 Participants
n=5 Participants
Hyperlipidemia
Hyperlipidemia
51 Participants
n=5 Participants
60 Participants
n=7 Participants
111 Participants
n=5 Participants
Hyperlipidemia
No hyperlipidemia
248 Participants
n=5 Participants
243 Participants
n=7 Participants
491 Participants
n=5 Participants
Prediabetes or diabetes
Diabetes or prediabetes
20 Participants
n=5 Participants
25 Participants
n=7 Participants
45 Participants
n=5 Participants
Prediabetes or diabetes
No diabetes or prediabetes
279 Participants
n=5 Participants
278 Participants
n=7 Participants
557 Participants
n=5 Participants
Weight goal
Lose weight
248 Participants
n=5 Participants
255 Participants
n=7 Participants
503 Participants
n=5 Participants
Weight goal
Maintain weight
51 Participants
n=5 Participants
48 Participants
n=7 Participants
99 Participants
n=5 Participants
Current smoker
Current smoker
8 Participants
n=5 Participants
9 Participants
n=7 Participants
17 Participants
n=5 Participants
Current smoker
Non-smoker
291 Participants
n=5 Participants
294 Participants
n=7 Participants
585 Participants
n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Population: We conducted an intent-to-treat analysis with all missing data imputed for 12 and 24-month outcomes.

Change in weight from baseline to 12 months

Outcome measures

Outcome measures
Measure
Personalized Feedback
n=299 Participants
Emails and letters providing personalized nutrition feedback about food choices and health, social norms, and financial incentives for healthy food choices Personalized nutrition feedback: Automated personalized nutrition feedback about cafeteria food purchases (weekly); social norms and small financial incentives to promote healthy purchases (monthly)
Control
n=303 Participants
Monthly letters with general nutrition information
Weight Change
0.6 kg
Interval 0.1 to 1.1
0.4 kg
Interval -0.1 to 0.9

SECONDARY outcome

Timeframe: 24 months

Population: We conducted an intent-to-treat analysis with all missing data imputed for 12 and 24-month outcomes.

Change in weight from baseline to 24 months

Outcome measures

Outcome measures
Measure
Personalized Feedback
n=299 Participants
Emails and letters providing personalized nutrition feedback about food choices and health, social norms, and financial incentives for healthy food choices Personalized nutrition feedback: Automated personalized nutrition feedback about cafeteria food purchases (weekly); social norms and small financial incentives to promote healthy purchases (monthly)
Control
n=303 Participants
Monthly letters with general nutrition information
Weight Change
1.5 kg
Interval 0.7 to 2.2
0.9 kg
Interval 0.2 to 1.6

SECONDARY outcome

Timeframe: 12 and 24 months

Population: We conducted an intent-to-treat analysis with all missing data imputed for 12 and 24-month outcomes.

Change from baseline in mean systolic and diastolic blood pressure (BP).

Outcome measures

Outcome measures
Measure
Personalized Feedback
n=299 Participants
Emails and letters providing personalized nutrition feedback about food choices and health, social norms, and financial incentives for healthy food choices Personalized nutrition feedback: Automated personalized nutrition feedback about cafeteria food purchases (weekly); social norms and small financial incentives to promote healthy purchases (monthly)
Control
n=303 Participants
Monthly letters with general nutrition information
Change in Blood Pressure
Change in systolic BP from baseline to 12 months
-1.9 mm Hg
Interval -3.4 to -0.3
-0.5 mm Hg
Interval -2.4 to 1.4
Change in Blood Pressure
Change in systolic BP from baseline to 24 months
-0.2 mm Hg
Interval -1.9 to 1.6
-1.7 mm Hg
Interval -3.4 to 0.1
Change in Blood Pressure
Change in diastolic BP from baseline to 12 months
-2.4 mm Hg
Interval -3.5 to -1.3
-0.8 mm Hg
Interval -2.1 to 0.4
Change in Blood Pressure
Change in diastolic BP from baseline to 24 months
-1.7 mm Hg
Interval -2.8 to -0.6
-1.8 mm Hg
Interval -3.0 to -0.6

SECONDARY outcome

Timeframe: 12 and 24 months

Population: We conducted an intent-to-treat analysis with all missing data imputed for 12 and 24-month outcomes.

Change from baseline in mean serum total cholesterol.

Outcome measures

Outcome measures
Measure
Personalized Feedback
n=299 Participants
Emails and letters providing personalized nutrition feedback about food choices and health, social norms, and financial incentives for healthy food choices Personalized nutrition feedback: Automated personalized nutrition feedback about cafeteria food purchases (weekly); social norms and small financial incentives to promote healthy purchases (monthly)
Control
n=303 Participants
Monthly letters with general nutrition information
Change in Total Cholesterol
Change from baseline to 12 months
-0.3 mg/dL
Interval -3.2 to 2.6
1.0 mg/dL
Interval -2.5 to 4.6
Change in Total Cholesterol
Change from baseline to 24 months
2.5 mg/dL
Interval -0.7 to 5.6
0.9 mg/dL
Interval -3.3 to 5.0

SECONDARY outcome

Timeframe: 12 and 24 months

Population: We conducted an intent-to-treat analysis with all missing data imputed for 12 and 24-month outcomes.

Change from baseline in mean serum LDL.

Outcome measures

Outcome measures
Measure
Personalized Feedback
n=299 Participants
Emails and letters providing personalized nutrition feedback about food choices and health, social norms, and financial incentives for healthy food choices Personalized nutrition feedback: Automated personalized nutrition feedback about cafeteria food purchases (weekly); social norms and small financial incentives to promote healthy purchases (monthly)
Control
n=303 Participants
Monthly letters with general nutrition information
Change in LDL Cholesterol
Change from baseline to 12 months
0.8 mg/dL
Interval -1.9 to 3.4
2.0 mg/dL
Interval -0.7 to 4.6
Change in LDL Cholesterol
Change from baseline to 24 months
4.9 mg/dL
Interval 1.9 to 7.9
3.8 mg/dL
Interval 0.3 to 7.2

SECONDARY outcome

Timeframe: 12 and 24 months

Population: We conducted an intent-to-treat analysis with all missing data imputed for 12 and 24-month outcomes.

Change in mean serum triglycerides.

Outcome measures

Outcome measures
Measure
Personalized Feedback
n=299 Participants
Emails and letters providing personalized nutrition feedback about food choices and health, social norms, and financial incentives for healthy food choices Personalized nutrition feedback: Automated personalized nutrition feedback about cafeteria food purchases (weekly); social norms and small financial incentives to promote healthy purchases (monthly)
Control
n=303 Participants
Monthly letters with general nutrition information
Change in Triglycerides
Change from baseline to 24 months
1.9 mg/dL
Interval -2.8 to 6.5
-2.2 mg/dL
Interval -7.5 to 3.2
Change in Triglycerides
Change from baseline to 12 months
-1.1 mg/dL
Interval -6.3 to 4.0
1.8 mg/dL
Interval -5.7 to 9.2

SECONDARY outcome

Timeframe: 12 and 24 months

Population: We conducted an intent-to-treat analysis with all missing data imputed for 12 and 24-month outcomes.

Change in mean serum HDL.

Outcome measures

Outcome measures
Measure
Personalized Feedback
n=299 Participants
Emails and letters providing personalized nutrition feedback about food choices and health, social norms, and financial incentives for healthy food choices Personalized nutrition feedback: Automated personalized nutrition feedback about cafeteria food purchases (weekly); social norms and small financial incentives to promote healthy purchases (monthly)
Control
n=303 Participants
Monthly letters with general nutrition information
Change in HDL Cholesterol
Change from baseline to 12 months
-1.5 mg/dL
Interval -2.6 to -0.4
-1.3 mg/dL
Interval -2.9 to 0.4
Change in HDL Cholesterol
Change from baseline to 24 months
-2.8 mg/dL
Interval -4.1 to -1.5
-2.5 mg/dL
Interval -3.9 to -1.1

SECONDARY outcome

Timeframe: 12 and 24 months

Population: We conducted an intent-to-treat analysis with all missing data imputed for 12 and 24-month outcomes.

Change in mean serum hemoglobin A1c.

Outcome measures

Outcome measures
Measure
Personalized Feedback
n=299 Participants
Emails and letters providing personalized nutrition feedback about food choices and health, social norms, and financial incentives for healthy food choices Personalized nutrition feedback: Automated personalized nutrition feedback about cafeteria food purchases (weekly); social norms and small financial incentives to promote healthy purchases (monthly)
Control
n=303 Participants
Monthly letters with general nutrition information
Change in Hemoglobin A1C
Change from baseline to 12 months
-0.1 Percentage
Interval -0.1 to 0.0
-0.1 Percentage
Interval -0.2 to 0.0
Change in Hemoglobin A1C
Change from baseline to 24 months
-0.1 Percentage
Interval -0.1 to 0.0
-0.1 Percentage
Interval -0.2 to -0.1

SECONDARY outcome

Timeframe: 12 and 24 months

Population: We conducted an intent-to-treat analysis with all missing data imputed for 12 and 24-month outcomes.

Change in cafeteria food purchases labeled green.

Outcome measures

Outcome measures
Measure
Personalized Feedback
n=299 Participants
Emails and letters providing personalized nutrition feedback about food choices and health, social norms, and financial incentives for healthy food choices Personalized nutrition feedback: Automated personalized nutrition feedback about cafeteria food purchases (weekly); social norms and small financial incentives to promote healthy purchases (monthly)
Control
n=303 Participants
Monthly letters with general nutrition information
Change in Green-labeled (Healthy) Food Purchases
Change from baseline to 12 months
9.4 percentage of purchases labeled green
Interval 8.0 to 10.7
2.0 percentage of purchases labeled green
Interval 0.9 to 3.1
Change in Green-labeled (Healthy) Food Purchases
Change from baseline to 24 months
5.7 percentage of purchases labeled green
Interval 4.1 to 7.4
0.9 percentage of purchases labeled green
Interval -0.6 to 2.4

SECONDARY outcome

Timeframe: 12 and 24 months

Population: We conducted an intent-to-treat analysis with all missing data imputed for 12 and 24-month outcomes.

Change in cafeteria food purchases labeled red.

Outcome measures

Outcome measures
Measure
Personalized Feedback
n=299 Participants
Emails and letters providing personalized nutrition feedback about food choices and health, social norms, and financial incentives for healthy food choices Personalized nutrition feedback: Automated personalized nutrition feedback about cafeteria food purchases (weekly); social norms and small financial incentives to promote healthy purchases (monthly)
Control
n=303 Participants
Monthly letters with general nutrition information
Change in Red-labeled (Unhealthy) Food Purchases
Change from baseline to 12 months
-4.8 percentage of purchases labeled red
Interval -5.5 to -4.0
-0.9 percentage of purchases labeled red
Interval -1.6 to -0.2
Change in Red-labeled (Unhealthy) Food Purchases
Change from baseline to 24 months
-4.1 percentage of purchases labeled red
Interval -5.0 to -3.2
-1.0 percentage of purchases labeled red
Interval -2.0 to 0.1

SECONDARY outcome

Timeframe: 12 and 24 months

Population: We conducted an intent-to-treat analysis with all missing data imputed for 12 and 24-month outcomes.

Change in overall score of the healthfulness of foods purchased, weighting the proportion of red, yellow, and green foods. To calculate the score, red foods are weighted 0, yellow are weighted 0.5, and green foods are weighted 1.0. Weighted scores are multiplied x 100, and the range is from 0 (least healthy cafeteria purchases, i.e. all red) to 100 (healthiest cafeteria purchases, i.e. all green).

Outcome measures

Outcome measures
Measure
Personalized Feedback
n=299 Participants
Emails and letters providing personalized nutrition feedback about food choices and health, social norms, and financial incentives for healthy food choices Personalized nutrition feedback: Automated personalized nutrition feedback about cafeteria food purchases (weekly); social norms and small financial incentives to promote healthy purchases (monthly)
Control
n=303 Participants
Monthly letters with general nutrition information
Change in Healthy Purchasing Score
Change from baseline to 12 months
7.1 score on a scale (range 0-100)
Interval 6.1 to 8.0
1.5 score on a scale (range 0-100)
Interval 0.7 to 2.2
Change in Healthy Purchasing Score
Change from baseline to 24 months
4.9 score on a scale (range 0-100)
Interval 3.8 to 6.0
0.9 score on a scale (range 0-100)
Interval -0.2 to 2.0

SECONDARY outcome

Timeframe: 12 and 24 months

Population: We conducted an intent-to-treat analysis with all missing data imputed for 12 and 24-month outcomes.

Change in Healthy Eating Index (HEI) scores. Healthy Eating Index Score is a measure of overall dietary quality that was calculated from two 24-hour dietary recalls. The range is from 0 (lowest diet quality) to 100 (highest diet quality) points.

Outcome measures

Outcome measures
Measure
Personalized Feedback
n=299 Participants
Emails and letters providing personalized nutrition feedback about food choices and health, social norms, and financial incentives for healthy food choices Personalized nutrition feedback: Automated personalized nutrition feedback about cafeteria food purchases (weekly); social norms and small financial incentives to promote healthy purchases (monthly)
Control
n=303 Participants
Monthly letters with general nutrition information
Change in Healthy Eating Index Score-15
Change from baseline to 12 months
1.1 score on a scale (range 0-100)
Interval -0.5 to 2.8
-0.5 score on a scale (range 0-100)
Interval -2.3 to 1.3
Change in Healthy Eating Index Score-15
Change from baseline to 24 months
0.6 score on a scale (range 0-100)
Interval -1.1 to 2.4
-0.9 score on a scale (range 0-100)
Interval -2.7 to 1.0

Adverse Events

Personalized Feedback

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Control

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

Dr. Anne Thorndike, Prinicipal Investigator

Massachusetts General Hospital

Phone: 6177244608

Results disclosure agreements

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