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Promoting Employee Health Through The Worksite Food Environment (ChooseWell 365)

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ClinicalTrials.gov Identifier: NCT02660086
Recruitment Status : Active, not recruiting
First Posted : January 21, 2016
Last Update Posted : June 21, 2018
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Anne N. Thorndike, MD, MPH, Massachusetts General Hospital

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.


Condition or disease Intervention/treatment Phase
Weight Food Choice Nutrition Intake Behavioral: Personalized nutrition feedback Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Promoting Employee Health Through The Worksite Food Environment
Actual Study Start Date : September 2016
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arm Intervention/treatment
Experimental: Personalized feedback
Emails and letters providing personalized nutrition feedback about food choices and health, social norms, and financial incentives for healthy food choices
Behavioral: Personalized nutrition feedback
Automated personalized nutrition feedback about cafeteria food purchases (weekly); social norms and small financial incentives to promote healthy purchases (monthly)

No Intervention: Control
Monthly letters with general nutrition information



Primary Outcome Measures :
  1. Weight [ Time Frame: one year ]
    Change in weight from baseline


Secondary Outcome Measures :
  1. Weight [ Time Frame: two years ]
    Change in weight from baseline

  2. Healthy food purchases [ Time Frame: One and two years ]
    Cafeteria food purchases labeled green

  3. Blood pressure [ Time Frame: One and two years ]
    Mean blood pressure

  4. Cholesterol [ Time Frame: One and two years ]
    Mean serum total, LDL, HDL, and triglycerides

  5. Hemoglobin A1C [ Time Frame: One and two years ]
    Mean serum hemoglobin A1c

  6. Healthy Eating Index Score [ Time Frame: One and two years ]
    Calculated from 24 hour dietary recalls



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02660086


Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
National Heart, Lung, and Blood Institute (NHLBI)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Responsible Party: Anne N. Thorndike, MD, MPH, Assistant Professor of Medicine, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02660086     History of Changes
Other Study ID Numbers: 5R01HL125486 ( U.S. NIH Grant/Contract )
R01DK114735 ( U.S. NIH Grant/Contract )
First Posted: January 21, 2016    Key Record Dates
Last Update Posted: June 21, 2018
Last Verified: June 2018

Keywords provided by Anne N. Thorndike, MD, MPH, Massachusetts General Hospital:
Weight
Prevention
Food choice
Nutrition
Behavior change
Behavioral economics
Feedback
Incentives