WeightChooseWell 365NCT02660086
Promoting Employee Health Through The Worksite Food Environment
A study testing Personalized nutrition feedback in people with Weight and Food Choice, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Weight, Food Choice, Nutrition Intake
- What is being tested?
- Personalized nutrition feedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 602 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to 15 Mar 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Employee at Massachusetts General Hospital; uses hospital cafeterias at least 4 times a week and willing to pay for purchases with employee debit card.
Who cannot join
- Planning to leave employment at MGH in the next year; currently pregnant; currently participating in the MGH employee wellness program Be Fit
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
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.
Read the 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.
- Conditions
- Weight, Food Choice, Nutrition Intake
- Being tested
- Personalized nutrition feedback
- Keywords
- Weight, Prevention, Food choice, Nutrition, Behavior change, Behavioral economics, Feedback, Incentives
- Medical subject headings
- Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized nutrition feedbackBehavioural
Automated personalized nutrition feedback about cafeteria food purchases (weekly); social norms and small financial incentives to promote healthy purchases (monthly)
| Study group | Role | What they receive |
|---|---|---|
| Personalized feedback | Experimental | Emails and letters providing personalized nutrition feedback about food choices and health, social norms, and financial incentives for healthy food choices Receives: Behavioral: Personalized nutrition feedback |
| Control | No intervention | Monthly letters with general nutrition information |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight Change
Change in weight from baseline to 12 months
Measured: 12 months
Secondary outcomes (11)
Weight Change
Change in weight from baseline to 24 months
Measured: 24 months
Change in Blood Pressure
Change from baseline in mean systolic and diastolic blood pressure (BP).
Measured: 12 and 24 months
Change in Total Cholesterol
Change from baseline in mean serum total cholesterol.
Measured: 12 and 24 months
Change in LDL Cholesterol
Change from baseline in mean serum LDL.
Measured: 12 and 24 months
Change in Triglycerides
Change in mean serum triglycerides.
Measured: 12 and 24 months
Change in HDL Cholesterol
Change in mean serum HDL.
Measured: 12 and 24 months
Change in Hemoglobin A1C
Change in mean serum hemoglobin A1c.
Measured: 12 and 24 months
Change in Green-labeled (Healthy) Food Purchases
Change in cafeteria food purchases labeled green.
Measured: 12 and 24 months
Change in Red-labeled (Unhealthy) Food Purchases
Change in cafeteria food purchases labeled red.
Measured: 12 and 24 months
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).
Measured: 12 and 24 months
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.
Measured: 12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2016 (estimated)
- Study startSep 2016
- Primary completionMar 2020
- Study completion15 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for WeightStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 602 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Principal investigator, Anne N. Thorndike, MD, MPH, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02660086
- Sponsor's protocol ID
- 5R01HL125486
- Other IDs
- R01DK114735
- Acronym
- ChooseWell 365
- Status last verified
- Nov 2021
- First submitted
- 18 Jan 2016
- Last updated
- 1 Dec 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Dashti HS, Alimenti K, Levy DE, Hivert MF, McCurley JL, Saxena R, Thorndike AN. Chronotype Polygenic Score and the Timing and Quality of Workplace Cafeteria Purchases: Secondary Analysis of the ChooseWell 365 Randomized Controlled Trial. Curr Dev Nutr. 2023 Feb 18;7(3):100048. doi: 10.1016/j.cdnut.2023.100048. eCollection 2023 Mar.
PubMed 37181927McCurley JL, Buckholtz JW, Roberto CA, Levy DE, Anderson EM, Chang Y, Thorndike AN. The association of impulsivity with effects of the ChooseWell 365 workplace nudge intervention on diet and weight. Transl Behav Med. 2023 May 13;13(5):281-288. doi: 10.1093/tbm/ibac103.
PubMed 36548448Thorndike AN, McCurley JL, Gelsomin ED, Anderson E, Chang Y, Porneala B, Johnson C, Rimm EB, Levy DE. Automated Behavioral Workplace Intervention to Prevent Weight Gain and Improve Diet: The ChooseWell 365 Randomized Clinical Trial. JAMA Netw Open. 2021 Jun 1;4(6):e2112528. doi: 10.1001/jamanetworkopen.2021.12528.
PubMed 34097048Dashti HS, Hivert MF, Levy DE, McCurley JL, Saxena R, Thorndike AN. Polygenic risk score for obesity and the quality, quantity, and timing of workplace food purchases: A secondary analysis from the ChooseWell 365 randomized trial. PLoS Med. 2020 Jul 21;17(7):e1003219. doi: 10.1371/journal.pmed.1003219. eCollection 2020 Jul.
PubMed 32692747Feig EH, Levy DE, McCurley JL, Rimm EB, Anderson EM, Gelsomin ED, Thorndike AN. Association of work-related and leisure-time physical activity with workplace food purchases, dietary quality, and health of hospital employees. BMC Public Health. 2019 Nov 27;19(1):1583. doi: 10.1186/s12889-019-7944-1.
PubMed 31775714Levy DE, Gelsomin ED, Rimm EB, Pachucki M, Sanford J, Anderson E, Johnson C, Schutzberg R, Thorndike AN. Design of ChooseWell 365: Randomized controlled trial of an automated, personalized worksite intervention to promote healthy food choices and prevent weight gain. Contemp Clin Trials. 2018 Dec;75:78-86. doi: 10.1016/j.cct.2018.11.004. Epub 2018 Nov 7.
PubMed 30414448
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Employee Health Through The Worksite Food Environment
- ClinicalTrials.gov ID
- NCT02660086
- Acronym / sponsor ID
- ChooseWell 365 / 5R01HL125486
- Conditions
- Weight, Food Choice, Nutrition Intake
- Keywords
- Weight, Prevention, Food choice, Nutrition, Behavior change, Behavioral economics, Feedback, Incentives
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 602 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Sep 2016 (actual)
- Primary completion
- Mar 2020 (actual)
- Study completion
- 15 Mar 2020 (actual)
- First posted
- 21 Jan 2016 (estimated)
- Results
- Posted 30 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Personalized feedback | Experimental | Behavioral: Personalized nutrition feedbackEmails and letters providing personalized nutrition feedback about food choices and health, social norms, and financial incentives for healthy food choices |
| Control | No intervention | –Monthly letters with general nutrition information |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Employee at Massachusetts General Hospital; uses hospital cafeterias at least 4 times a week and willing to pay for purchases with employee debit card.
Key exclusion criteria (1 listed)
- Planning to leave employment at MGH in the next year; currently pregnant; currently participating in the MGH employee wellness program Be Fit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personalized nutrition feedbackAutomated personalized nutrition feedback about cafeteria food purchases (weekly); social norms and small financial incentives to promote healthy purchases (monthly) | Behavioural | Personalized feedback |
Primary outcome
Weight Change
Time frame: 12 months
Change in weight from baseline to 12 months
11 secondary outcomes
Weight Change
Time frame: 24 months
Change in Blood Pressure
Time frame: 12 and 24 months
Change in Total Cholesterol
Time frame: 12 and 24 months
Change in LDL Cholesterol
Time frame: 12 and 24 months
Change in Triglycerides
Time frame: 12 and 24 months
Change in HDL Cholesterol
Time frame: 12 and 24 months
Change in Hemoglobin A1C
Time frame: 12 and 24 months
Change in Green-labeled (Healthy) Food Purchases
Time frame: 12 and 24 months
Change in Red-labeled (Unhealthy) Food Purchases
Time frame: 12 and 24 months
Change in Healthy Purchasing Score
Time frame: 12 and 24 months
Change in Healthy Eating Index Score-15
Time frame: 12 and 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37181927Dashti HS, Alimenti K, Levy DE, Hivert MF, McCurley JL, Saxena R, Thorndike AN. Chronotype Polygenic Score and the Timing and Quality of Workplace Cafeteria Purchases: Secondary Analysis of the ChooseWell 365 Randomized Controlled Trial. Curr Dev Nutr. 2023 Feb 18;7(3):100048. doi: 10.1016/j.cdnut.2023.100048. eCollection 2023 Mar.
- Derived from this study: PubMed 36548448McCurley JL, Buckholtz JW, Roberto CA, Levy DE, Anderson EM, Chang Y, Thorndike AN. The association of impulsivity with effects of the ChooseWell 365 workplace nudge intervention on diet and weight. Transl Behav Med. 2023 May 13;13(5):281-288. doi: 10.1093/tbm/ibac103.
- Derived from this study: PubMed 34097048Thorndike AN, McCurley JL, Gelsomin ED, Anderson E, Chang Y, Porneala B, Johnson C, Rimm EB, Levy DE. Automated Behavioral Workplace Intervention to Prevent Weight Gain and Improve Diet: The ChooseWell 365 Randomized Clinical Trial. JAMA Netw Open. 2021 Jun 1;4(6):e2112528. doi: 10.1001/jamanetworkopen.2021.12528.
- Derived from this study: PubMed 32692747Dashti HS, Hivert MF, Levy DE, McCurley JL, Saxena R, Thorndike AN. Polygenic risk score for obesity and the quality, quantity, and timing of workplace food purchases: A secondary analysis from the ChooseWell 365 randomized trial. PLoS Med. 2020 Jul 21;17(7):e1003219. doi: 10.1371/journal.pmed.1003219. eCollection 2020 Jul.
- Derived from this study: PubMed 31775714Feig EH, Levy DE, McCurley JL, Rimm EB, Anderson EM, Gelsomin ED, Thorndike AN. Association of work-related and leisure-time physical activity with workplace food purchases, dietary quality, and health of hospital employees. BMC Public Health. 2019 Nov 27;19(1):1583. doi: 10.1186/s12889-019-7944-1.
- Derived from this study: PubMed 30414448Levy DE, Gelsomin ED, Rimm EB, Pachucki M, Sanford J, Anderson E, Johnson C, Schutzberg R, Thorndike AN. Design of ChooseWell 365: Randomized controlled trial of an automated, personalized worksite intervention to promote healthy food choices and prevent weight gain. Contemp Clin Trials. 2018 Dec;75:78-86. doi: 10.1016/j.cct.2018.11.004. Epub 2018 Nov 7.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized nutrition feedback in people with Weight and Food Choice, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight Change (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02660086, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2021.