Food Choice, Nutrition Intake, Weight
Conditions
Keywords
Weight, Prevention, Food choice, Nutrition, Behavior change, Behavioral economics, Feedback, Incentives
Brief summary
This project tests a scalable and sustainable approach to weight gain prevention in a population of employees by using the worksite environment to deliver personalized feedback about worksite food purchases, daily calorie goals, social norms for healthy eating, and financial incentives for healthy food purchases. In the future, similar strategies could be adopted by other worksites, institutions, and food retailers and could contribute to the long-term environmental and social changes needed to reverse the obesity epidemic in the United States and worldwide. The overall objective of ancillary studies added on to this project is to examine the psychological traits, cognitive skills, and genes that may influence the impact of the behavioral intervention to promote healthy diet and weight among employees at a large hospital worksite.
Detailed description
Adults in the United States gain an average of 1-2 pounds a year. Interventions to prevent weight gain at the population level are needed to reverse the rising prevalence of obesity. Although individual-level interventions can result in large weight changes among small groups of individuals, achieving changes in the population will require long-term strategies that create healthier food environments, establish new social norms, and improve motivation and skills for healthy lifestyle behaviors. The worksite is ideal for interventions to address weight and lifestyle behaviors because a majority of adults are employed, and provisions in the Affordable Care Act encourage worksite wellness. Our research team at Massachusetts General Hospital (MGH) has demonstrated that behavioral economics strategies, including traffic-light labels, choice architecture, social norms, and financial incentives, improve employees' healthy food choices. The proposed project will address the critical next phase of this research to determine if a worksite intervention delivered through the food environment can prevent weight gain and reduce cardiovascular risk of employees. This project builds on the established traffic-light labeling system at MGH and tests an intervention that aims to increase nutrition knowledge, motivate change in lifestyle behaviors, and promote socially normative behavior for healthier lifestyles among employees. The intervention will be integrated into the flow of the work day, thus lowering burden to employees and the employer. Study Design: In a randomized controlled trial, 600 MGH employees will be assigned to: 1) an intervention arm with automated, personalized feedback about (a) worksite food purchases and calorie and physical activity goals (weekly emails) and (b) social norm feedback plus small financial incentives for healthy food purchases (monthly letters) or 2) a control arm (standardized monthly letters). Study outcomes will be assessed at 1 year (end of intervention) and 2 year follow-up. The primary outcome is change in weight at 1 year. Secondary outcomes are cardiovascular risk factors, worksite food purchases, and dietary intake (as measured by the Healthy Eating Index). A novel exploratory outcome will be healthy food purchases of co-workers who are socially connected to study subjects. Aim 1 is to determine if employees assigned to the intervention have less weight gain and lower cardiovascular risk factors than the control group at 1 year and 2-year follow-up. Aim 2 is to determine if employees assigned to the intervention group make healthier food choices than the control group at 1 year and 2-year follow-up. Exploratory Aim 3 is to determine if employees socially connected to the intervention group make healthier worksite food choices over 1 year than employees connected to the control group. Implications: This innovative strategy utilizing personalized feedback, social norms, and financial incentives will provide a scalable and sustainable model that could be adopted in other worksite, institutional, and retail settings to prevent obesity at the population level. The overall objective of the ancillary studies added on to this project is to examine the psychological traits, cognitive skills, and genes that may influence the impact of a behaviorally-informed intervention on dietary choices, weight, and other objective health indicators. This research will expand on the randomized trial by examining psychological traits (impulsivity, self-control, social acceptance), cognitive skills (numeracy, health literacy), and genes (97 known BMI loci) that are associated with obesity and poor health and are specifically targeted by the intervention. We will use validated measures to assess traits and skills and well-established methods for genotyping and calculating genetic risk scores. Aim 1 will determine if psychological traits moderate the behavioral intervention effects on diet and weight. Aim 2 will determine if cognitive skills moderate the behavioral intervention effects on diet and weight. Aim 3 will determine if genetic risk for obesity moderates the intervention effect on weight. In secondary analyses, potential mediators of diet and weight outcomes, including dietary intent, self-efficacy, reward sensitivity, perceived norms, and perceived stress, will be assessed. Implications: Results of this research will l will inform the future design and implementation of more effective, tailored, and sustainable population approaches for obesity prevention.
Interventions
BEHAVIORALPersonalized nutrition feedback
Automated personalized nutrition feedback about cafeteria food purchases (weekly); social norms and small financial incentives to promote healthy purchases (monthly)
Sponsors
Massachusetts General Hospital
National Heart, Lung, and Blood Institute (NHLBI)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Employee at Massachusetts General Hospital; uses hospital cafeterias at least 4 times a week and willing to pay for purchases with employee debit card.
Exclusion criteria
* Planning to leave employment at MGH in the next year; currently pregnant; currently participating in the MGH employee wellness program Be Fit
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight Change | 12 months | Change in weight from baseline to 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Blood Pressure | 12 and 24 months | Change from baseline in mean systolic and diastolic blood pressure (BP). |
| Change in Total Cholesterol | 12 and 24 months | Change from baseline in mean serum total cholesterol. |
| Change in LDL Cholesterol | 12 and 24 months | Change from baseline in mean serum LDL. |
| Change in Triglycerides | 12 and 24 months | Change in mean serum triglycerides. |
| Change in HDL Cholesterol | 12 and 24 months | Change in mean serum HDL. |
| Weight Change | 24 months | Change in weight from baseline to 24 months |
| Change in Green-labeled (Healthy) Food Purchases | 12 and 24 months | Change in cafeteria food purchases labeled green. |
| Change in Red-labeled (Unhealthy) Food Purchases | 12 and 24 months | Change in cafeteria food purchases labeled red. |
| Change in Healthy Purchasing Score | 12 and 24 months | 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). |
| Change in Healthy Eating Index Score-15 | 12 and 24 months | 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. |
| Change in Hemoglobin A1C | 12 and 24 months | Change in mean serum hemoglobin A1c. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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) | 299 |
| Control Monthly letters with general nutrition information | 303 |
| Total | 602 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study- 12-month | Became ineligible: new job in cafeteria | 1 | 0 |
| 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 | Withdrawal by Subject | 5 | 5 |
| 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
| Characteristic | Control | Personalized Feedback | Total |
|---|---|---|---|
| Age, Continuous | 43.8 years STANDARD_DEVIATION 12.5 | 43.5 years STANDARD_DEVIATION 12 | 43.6 years STANDARD_DEVIATION 12.2 |
| Body Mass Index (BMI) | 27.9 kg/m^2 STANDARD_DEVIATION 6.4 | 28.6 kg/m^2 STANDARD_DEVIATION 6.6 | 28.3 kg/m^2 STANDARD_DEVIATION 6.5 |
| Current smoker Current smoker | 9 Participants | 8 Participants | 17 Participants |
| Current smoker Non-smoker | 294 Participants | 291 Participants | 585 Participants |
| Diastolic blood pressure | 70.2 mmHg STANDARD_DEVIATION 9.9 | 71.3 mmHg STANDARD_DEVIATION 9.9 | 70.7 mmHg STANDARD_DEVIATION 9.9 |
| Education College degree | 117 Participants | 123 Participants | 240 Participants |
| Education Graduate degree | 146 Participants | 138 Participants | 284 Participants |
| Education High school or some college | 39 Participants | 36 Participants | 75 Participants |
| Education Not reported | 1 Participants | 2 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 17 Participants | 17 Participants | 34 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 286 Participants | 282 Participants | 568 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| HDL cholesterol | 62.1 mg/dL STANDARD_DEVIATION 17.4 | 63.0 mg/dL STANDARD_DEVIATION 18.5 | 62.5 mg/dL STANDARD_DEVIATION 17.9 |
| Healthy Eating Index Score | 61.0 units on a scale from 0-100 STANDARD_DEVIATION 12.5 | 59.7 units on a scale from 0-100 STANDARD_DEVIATION 12.3 | 60.4 units on a scale from 0-100 STANDARD_DEVIATION 12.4 |
| Healthy purchasing score | 68.8 units on a scale from 0-100 STANDARD_DEVIATION 13.1 | 67.2 units on a scale from 0-100 STANDARD_DEVIATION 12.5 | 68.0 units on a scale from 0-100 STANDARD_DEVIATION 12.8 |
| Hemoglobin A1C | 5.5 percent STANDARD_DEVIATION 0.6 | 5.5 percent STANDARD_DEVIATION 0.5 | 5.5 percent STANDARD_DEVIATION 0.6 |
| Hyperlipidemia Hyperlipidemia | 60 Participants | 51 Participants | 111 Participants |
| Hyperlipidemia No hyperlipidemia | 243 Participants | 248 Participants | 491 Participants |
| Hypertension Hypertension | 49 Participants | 51 Participants | 100 Participants |
| Hypertension No hypertension | 254 Participants | 248 Participants | 502 Participants |
| Job category Administrative or service | 48 Participants | 36 Participants | 84 Participants |
| Job category Crafts or technicians | 31 Participants | 36 Participants | 67 Participants |
| Job category Management or professionals | 184 Participants | 193 Participants | 377 Participants |
| Job category Physicians or PhDs | 40 Participants | 34 Participants | 74 Participants |
| LDL cholesterol | 101.5 mg/dL STANDARD_DEVIATION 33.2 | 102.1 mg/dL STANDARD_DEVIATION 30.6 | 101.8 mg/dL STANDARD_DEVIATION 31.9 |
| Percentage green-labeled (healthy) food purchased | 52.3 percent STANDARD_DEVIATION 17.1 | 50.1 percent STANDARD_DEVIATION 16.3 | 51.2 percent STANDARD_DEVIATION 16.7 |
| Percentage red-labeled food purchased | 14.6 percent STANDARD_DEVIATION 10.9 | 15.7 percent STANDARD_DEVIATION 10.8 | 15.1 percent STANDARD_DEVIATION 10.9 |
| Percentage yellow-labeled food purchased | 33.1 percent STANDARD_DEVIATION 11.9 | 34.2 percent STANDARD_DEVIATION 11.8 | 33.6 percent STANDARD_DEVIATION 11.9 |
| Prediabetes or diabetes Diabetes or prediabetes | 25 Participants | 20 Participants | 45 Participants |
| Prediabetes or diabetes No diabetes or prediabetes | 278 Participants | 279 Participants | 557 Participants |
| Race/Ethnicity, Customized Asian | 13 Participants | 14 Participants | 27 Participants |
| Race/Ethnicity, Customized Black | 26 Participants | 28 Participants | 54 Participants |
| Race/Ethnicity, Customized Other race or not reported | 22 Participants | 11 Participants | 33 Participants |
| Race/Ethnicity, Customized White | 242 Participants | 246 Participants | 488 Participants |
| Region of Enrollment United States | 303 participants | 299 participants | 602 participants |
| Sex: Female, Male Female | 248 Participants | 230 Participants | 478 Participants |
| Sex: Female, Male Male | 55 Participants | 69 Participants | 124 Participants |
| Systolic blood pressure | 120.4 mmHg STANDARD_DEVIATION 14.7 | 121.4 mmHg STANDARD_DEVIATION 14.4 | 120.9 mmHg STANDARD_DEVIATION 14.5 |
| Total cholesterol | 182.7 mg/dL STANDARD_DEVIATION 38.2 | 183.8 mg/dL STANDARD_DEVIATION 34.8 | 183.2 mg/dL STANDARD_DEVIATION 36.5 |
| Triglycerides | 94.5 mg/dL STANDARD_DEVIATION 67 | 94.5 mg/dL STANDARD_DEVIATION 56.3 | 94.5 mg/dL STANDARD_DEVIATION 61.9 |
| Weight | 77.0 kg STANDARD_DEVIATION 18.3 | 79.8 kg STANDARD_DEVIATION 18.8 | 78.4 kg STANDARD_DEVIATION 18.6 |
| Weight category Normal weight (BMI <25) | 119 Participants | 109 Participants | 228 Participants |
| Weight category Obese (BMI >=30) | 84 Participants | 98 Participants | 182 Participants |
| Weight category Overweight (BMI 25-29.9) | 100 Participants | 92 Participants | 192 Participants |
| Weight goal Lose weight | 255 Participants | 248 Participants | 503 Participants |
| Weight goal Maintain weight | 48 Participants | 51 Participants | 99 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 299 | 0 / 303 |
| other Total, other adverse events | 0 / 299 | 0 / 303 |
| serious Total, serious adverse events | 0 / 299 | 0 / 303 |
Outcome results
Primary
Weight Change
Change in weight from baseline to 12 months
Time frame: 12 months
Population: We conducted an intent-to-treat analysis with all missing data imputed for 12 and 24-month outcomes.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Personalized Feedback | Weight Change | 0.6 kg |
| Control | Weight Change | 0.4 kg |
p-value: 0.795% CI: [-0.6, 1]Mixed Models Analysis
Secondary
Change in Blood Pressure
Change from baseline in mean systolic and diastolic blood pressure (BP).
Time frame: 12 and 24 months
Population: We conducted an intent-to-treat analysis with all missing data imputed for 12 and 24-month outcomes.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Personalized Feedback | Change in Blood Pressure | Change in systolic BP from baseline to 12 months | -1.9 mm Hg |
| Personalized Feedback | Change in Blood Pressure | Change in systolic BP from baseline to 24 months | -0.2 mm Hg |
| Personalized Feedback | Change in Blood Pressure | Change in diastolic BP from baseline to 12 months | -2.4 mm Hg |
| Personalized Feedback | Change in Blood Pressure | Change in diastolic BP from baseline to 24 months | -1.7 mm Hg |
| Control | Change in Blood Pressure | Change in diastolic BP from baseline to 24 months | -1.8 mm Hg |
| Control | Change in Blood Pressure | Change in systolic BP from baseline to 12 months | -0.5 mm Hg |
| Control | Change in Blood Pressure | Change in diastolic BP from baseline to 12 months | -0.8 mm Hg |
| Control | Change in Blood Pressure | Change in systolic BP from baseline to 24 months | -1.7 mm Hg |
Comparison: Change in systolic BP at 12 monthsp-value: 0.2495% CI: [-3.6, 0.9]Mixed Models Analysis
Comparison: Change in systolic BP at 24 monthsp-value: 0.1995% CI: [-0.7, 3.7]Mixed Models Analysis
Comparison: Change in diastolic BP at 12 monthsp-value: 0.0795% CI: [-3.2, 0.1]Mixed Models Analysis
Comparison: Change in diastolic BP at 24 monthsp-value: 0.9495% CI: [-1.5, 1.6]Mixed Models Analysis
Secondary
Change in Green-labeled (Healthy) Food Purchases
Change in cafeteria food purchases labeled green.
Time frame: 12 and 24 months
Population: We conducted an intent-to-treat analysis with all missing data imputed for 12 and 24-month outcomes.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Personalized Feedback | Change in Green-labeled (Healthy) Food Purchases | Change from baseline to 12 months | 9.4 percentage of purchases labeled green |
| Personalized Feedback | Change in Green-labeled (Healthy) Food Purchases | Change from baseline to 24 months | 5.7 percentage of purchases labeled green |
| Control | Change in Green-labeled (Healthy) Food Purchases | Change from baseline to 12 months | 2.0 percentage of purchases labeled green |
| Control | Change in Green-labeled (Healthy) Food Purchases | Change from baseline to 24 months | 0.9 percentage of purchases labeled green |
Comparison: Change in green labeled purchases during 12 month intervention (months 1-12) compared to baseline 12 monthsp-value: <0.00195% CI: [5.4, 9.3]Mixed Models Analysis
Comparison: Change in green-labeled purhases during 12 month follow-up (months 13-24) compared to 12 month baselinep-value: <0.00195% CI: [2.9, 6.8]Mixed Models Analysis
Secondary
Change in HDL Cholesterol
Change in mean serum HDL.
Time frame: 12 and 24 months
Population: We conducted an intent-to-treat analysis with all missing data imputed for 12 and 24-month outcomes.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Personalized Feedback | Change in HDL Cholesterol | Change from baseline to 12 months | -1.5 mg/dL |
| Personalized Feedback | Change in HDL Cholesterol | Change from baseline to 24 months | -2.8 mg/dL |
| Control | Change in HDL Cholesterol | Change from baseline to 12 months | -1.3 mg/dL |
| Control | Change in HDL Cholesterol | Change from baseline to 24 months | -2.5 mg/dL |
Comparison: Change in HDL at 12 monthsp-value: 0.895% CI: [-1.9, 1.5]Mixed Models Analysis
Comparison: Change in HDL at 24 monthsp-value: 0.7295% CI: [-1.9, 1.3]Mixed Models Analysis
Secondary
Change in Healthy Eating Index Score-15
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.
Time frame: 12 and 24 months
Population: We conducted an intent-to-treat analysis with all missing data imputed for 12 and 24-month outcomes.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Personalized Feedback | Change in Healthy Eating Index Score-15 | Change from baseline to 12 months | 1.1 score on a scale (range 0-100) |
| Personalized Feedback | Change in Healthy Eating Index Score-15 | Change from baseline to 24 months | 0.6 score on a scale (range 0-100) |
| Control | Change in Healthy Eating Index Score-15 | Change from baseline to 12 months | -0.5 score on a scale (range 0-100) |
| Control | Change in Healthy Eating Index Score-15 | Change from baseline to 24 months | -0.9 score on a scale (range 0-100) |
Comparison: Change in HEI scores at 12 months.95% CI: [-0.6, 4.1]
Comparison: Change in HEI scores at 24 months95% CI: [-0.7, 3.8]
Secondary
Change in Healthy Purchasing Score
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).
Time frame: 12 and 24 months
Population: We conducted an intent-to-treat analysis with all missing data imputed for 12 and 24-month outcomes.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Personalized Feedback | Change in Healthy Purchasing Score | Change from baseline to 12 months | 7.1 score on a scale (range 0-100) |
| Personalized Feedback | Change in Healthy Purchasing Score | Change from baseline to 24 months | 4.9 score on a scale (range 0-100) |
| Control | Change in Healthy Purchasing Score | Change from baseline to 12 months | 1.5 score on a scale (range 0-100) |
| Control | Change in Healthy Purchasing Score | Change from baseline to 24 months | 0.9 score on a scale (range 0-100) |
Comparison: Change in healthy purchasing score during 12 month intervention (months 1-12) compared to baseline 12 monthsp-value: <0.00195% CI: [4.2, 7]Mixed Models Analysis
Comparison: Change in Healthy Purchasing Score during 12 month follow up (months 13-24) compared to baseline 12 monthsp-value: <0.00195% CI: [2.6, 5.3]Mixed Models Analysis
Secondary
Change in Hemoglobin A1C
Change in mean serum hemoglobin A1c.
Time frame: 12 and 24 months
Population: We conducted an intent-to-treat analysis with all missing data imputed for 12 and 24-month outcomes.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Personalized Feedback | Change in Hemoglobin A1C | Change from baseline to 12 months | -0.1 Percentage |
| Personalized Feedback | Change in Hemoglobin A1C | Change from baseline to 24 months | -0.1 Percentage |
| Control | Change in Hemoglobin A1C | Change from baseline to 12 months | -0.1 Percentage |
| Control | Change in Hemoglobin A1C | Change from baseline to 24 months | -0.1 Percentage |
Comparison: Change in hemoglobin A1C at 12 monthsp-value: 0.6295% CI: [-0.1, 0.1]Mixed Models Analysis
Comparison: Change in hemoglobin A1C at 24 monthsp-value: 0.495% CI: [0, 0.1]Mixed Models Analysis
Secondary
Change in LDL Cholesterol
Change from baseline in mean serum LDL.
Time frame: 12 and 24 months
Population: We conducted an intent-to-treat analysis with all missing data imputed for 12 and 24-month outcomes.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Personalized Feedback | Change in LDL Cholesterol | Change from baseline to 12 months | 0.8 mg/dL |
| Personalized Feedback | Change in LDL Cholesterol | Change from baseline to 24 months | 4.9 mg/dL |
| Control | Change in LDL Cholesterol | Change from baseline to 12 months | 2.0 mg/dL |
| Control | Change in LDL Cholesterol | Change from baseline to 24 months | 3.8 mg/dL |
Comparison: Change in LDL at 12 monthsp-value: 0.5195% CI: [-4.8, 2.4]Mixed Models Analysis
Comparison: Change in LDL at 24 monthsp-value: 0.695% CI: [-3.4, 5.7]Mixed Models Analysis
Secondary
Change in Red-labeled (Unhealthy) Food Purchases
Change in cafeteria food purchases labeled red.
Time frame: 12 and 24 months
Population: We conducted an intent-to-treat analysis with all missing data imputed for 12 and 24-month outcomes.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Personalized Feedback | Change in Red-labeled (Unhealthy) Food Purchases | Change from baseline to 12 months | -4.8 percentage of purchases labeled red |
| Personalized Feedback | Change in Red-labeled (Unhealthy) Food Purchases | Change from baseline to 24 months | -4.1 percentage of purchases labeled red |
| Control | Change in Red-labeled (Unhealthy) Food Purchases | Change from baseline to 12 months | -0.9 percentage of purchases labeled red |
| Control | Change in Red-labeled (Unhealthy) Food Purchases | Change from baseline to 24 months | -1.0 percentage of purchases labeled red |
Comparison: Change in red labeled purchases during 12 month intervention (months 1-12) compared to baseline 12 monthsp-value: <0.00195% CI: [-5, -2.7]Mixed Models Analysis
Comparison: Change in red labeled purchases during 12-month follow up (months 13-24) compared to baseline 12 monthsp-value: <0.00195% CI: [-4.3, -2]Mixed Models Analysis
Secondary
Change in Total Cholesterol
Change from baseline in mean serum total cholesterol.
Time frame: 12 and 24 months
Population: We conducted an intent-to-treat analysis with all missing data imputed for 12 and 24-month outcomes.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Personalized Feedback | Change in Total Cholesterol | Change from baseline to 12 months | -0.3 mg/dL |
| Personalized Feedback | Change in Total Cholesterol | Change from baseline to 24 months | 2.5 mg/dL |
| Control | Change in Total Cholesterol | Change from baseline to 12 months | 1.0 mg/dL |
| Control | Change in Total Cholesterol | Change from baseline to 24 months | 0.9 mg/dL |
Comparison: Change in total cholesterol at 12 monthsp-value: 0.5495% CI: [-5.6, 2.9]Mixed Models Analysis
Comparison: Change in total cholesterol at 24 monthsp-value: 0.5395% CI: [-3.5, 6.7]Mixed Models Analysis
Secondary
Change in Triglycerides
Change in mean serum triglycerides.
Time frame: 12 and 24 months
Population: We conducted an intent-to-treat analysis with all missing data imputed for 12 and 24-month outcomes.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Personalized Feedback | Change in Triglycerides | Change from baseline to 12 months | -1.1 mg/dL |
| Personalized Feedback | Change in Triglycerides | Change from baseline to 24 months | 1.9 mg/dL |
| Control | Change in Triglycerides | Change from baseline to 12 months | 1.8 mg/dL |
| Control | Change in Triglycerides | Change from baseline to 24 months | -2.2 mg/dL |
Comparison: Change in triglycerides at 12 monthsp-value: 0.4895% CI: [-10.8, 5.1]Mixed Models Analysis
Comparison: Change in triglycerides at 24 monthsp-value: 0.2995% CI: [-3.4, 11.5]Mixed Models Analysis
Secondary
Weight Change
Change in weight from baseline to 24 months
Time frame: 24 months
Population: We conducted an intent-to-treat analysis with all missing data imputed for 12 and 24-month outcomes.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Personalized Feedback | Weight Change | 1.5 kg |
| Control | Weight Change | 0.9 kg |
p-value: 0.295% CI: [-0.3, 1.4]Mixed Models Analysis