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Promoting Employee Health Through The Worksite Food Environment

NCT ID: NCT02660086

Last Updated: 2021-12-01

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

602 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2020-03-15

Brief Summary

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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

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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

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Weight Food Choice Nutrition Intake

Keywords

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Weight Prevention Food choice Nutrition Behavior change Behavioral economics Feedback Incentives

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Personalized feedback

Emails and letters providing personalized nutrition feedback about food choices and health, social norms, and financial incentives for healthy food choices

Group Type EXPERIMENTAL

Personalized nutrition feedback

Intervention Type BEHAVIORAL

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Personalized nutrition feedback

Automated personalized nutrition feedback about cafeteria food purchases (weekly); social norms and small financial incentives to promote healthy purchases (monthly)

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Anne N. Thorndike, MD, MPH

Assistant Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 37181927 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36548448 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34097048 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32692747 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31775714 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30414448 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

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Other Identifiers

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R01DK114735

Identifier Type: NIH

Identifier Source: secondary_id

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5R01HL125486

Identifier Type: NIH

Identifier Source: org_study_id

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