AzTrials
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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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

Other trials in United States

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.

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 groups in NCT02660086
Study groupRoleWhat they receive
Personalized feedbackExperimentalEmails 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
ControlNo interventionMonthly letters with general nutrition information

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Weight Change

    Change in weight from baseline to 12 months

    Measured: 12 months

Secondary outcomes (11)
  1. Weight Change

    Change in weight from baseline to 24 months

    Measured: 24 months

  2. Change in Blood Pressure

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

    Measured: 12 and 24 months

  3. Change in Total Cholesterol

    Change from baseline in mean serum total cholesterol.

    Measured: 12 and 24 months

  4. Change in LDL Cholesterol

    Change from baseline in mean serum LDL.

    Measured: 12 and 24 months

  5. Change in Triglycerides

    Change in mean serum triglycerides.

    Measured: 12 and 24 months

  6. Change in HDL Cholesterol

    Change in mean serum HDL.

    Measured: 12 and 24 months

  7. Change in Hemoglobin A1C

    Change in mean serum hemoglobin A1c.

    Measured: 12 and 24 months

  8. Change in Green-labeled (Healthy) Food Purchases

    Change in cafeteria food purchases labeled green.

    Measured: 12 and 24 months

  9. Change in Red-labeled (Unhealthy) Food Purchases

    Change in cafeteria food purchases labeled red.

    Measured: 12 and 24 months

  10. 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

  11. 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.

  1. First posted21 Jan 2016 (estimated)
  2. Study startSep 2016
  3. Primary completionMar 2020
  4. Study completion15 Mar 2020

Resources

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)
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
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 37181927
  • McCurley 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 36548448
  • Thorndike 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 34097048
  • Dashti 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 32692747
  • Feig 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 31775714
  • Levy 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

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.

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