NCT02660086

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
602

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 18, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 21, 2016

Completed
7 months until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2020

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

November 30, 2021

Completed
Last Updated

December 1, 2021

Status Verified

November 1, 2021

Enrollment Period

3.5 years

First QC Date

January 18, 2016

Results QC Date

August 22, 2021

Last Update Submit

November 29, 2021

Conditions

WeightFood ChoiceNutrition Intake

Keywords

WeightPreventionFood choiceNutritionBehavior changeBehavioral economicsFeedbackIncentives

Outcome Measures

Primary Outcomes (1)

  • Weight Change

    Change in weight from baseline to 12 months

    12 months

Secondary Outcomes (11)

  • Weight Change

    24 months

  • Change in Blood Pressure

    12 and 24 months

  • Change in Total Cholesterol

    12 and 24 months

  • Change in LDL Cholesterol

    12 and 24 months

  • Change in Triglycerides

    12 and 24 months

  • +6 more secondary outcomes

Study Arms (2)

Personalized feedback

EXPERIMENTAL

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

Control

NO INTERVENTION

Monthly letters with general nutrition information

Interventions

Personalized nutrition feedbackBEHAVIORAL

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

Personalized feedback

Eligibility Criteria

Age21 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Employee at Massachusetts General Hospital; uses hospital cafeterias at least 4 times a week and willing to pay for purchases with employee debit card.

You may not qualify if:

  • Planning to leave employment at MGH in the next year; currently pregnant; currently participating in the MGH employee wellness program Be Fit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (6)

  • 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.

    PMID: 37181927DERIVED

  • 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.

    PMID: 36548448DERIVED

  • 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.

    PMID: 34097048DERIVED

  • 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.

    PMID: 32692747DERIVED

  • 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.

    PMID: 31775714DERIVED

  • 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.

    PMID: 30414448DERIVED

MeSH Terms

Conditions

Body Weight

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr. Anne Thorndike, Prinicipal Investigator
Organization
Massachusetts General Hospital
athorndike@mgh.harvard.edu
6177244608

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medicine

Study Record Dates

First Submitted

January 18, 2016

First Posted

January 21, 2016

Study Start

September 1, 2016

Primary Completion

March 1, 2020

Study Completion

March 15, 2020

Last Updated

December 1, 2021

Results First Posted

November 30, 2021

Record last verified: 2021-11

Locations

US(1)