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

2021年11月29日 更新者:Anne N. Thorndike, MD, MPH、Massachusetts General Hospital

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.

調査の概要

詳細な説明

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.

研究の種類

介入

入学 (実際)

602

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • Massachusetts
      • Boston、Massachusetts、アメリカ、02114
        • Massachusetts General Hospital

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

21年~75年 (大人、高齢者)

健康ボランティアの受け入れ

はい

受講資格のある性別

全て

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:防止
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:独身

武器と介入

参加者グループ / アーム
介入・治療
実験的:Personalized feedback
Emails and letters providing personalized nutrition feedback about food choices and health, social norms, and financial incentives for healthy food choices
Automated personalized nutrition feedback about cafeteria food purchases (weekly); social norms and small financial incentives to promote healthy purchases (monthly)
介入なし:Control
Monthly letters with general nutrition information

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Weight Change
時間枠:12 months
Change in weight from baseline to 12 months
12 months

二次結果の測定

結果測定
メジャーの説明
時間枠
Weight Change
時間枠:24 months
Change in weight from baseline to 24 months
24 months
Change in Blood Pressure
時間枠:12 and 24 months
Change from baseline in mean systolic and diastolic blood pressure (BP).
12 and 24 months
Change in Total Cholesterol
時間枠:12 and 24 months
Change from baseline in mean serum total cholesterol.
12 and 24 months
Change in LDL Cholesterol
時間枠:12 and 24 months
Change from baseline in mean serum LDL.
12 and 24 months
Change in Triglycerides
時間枠:12 and 24 months
Change in mean serum triglycerides.
12 and 24 months
Change in HDL Cholesterol
時間枠:12 and 24 months
Change in mean serum HDL.
12 and 24 months
Change in Hemoglobin A1C
時間枠:12 and 24 months
Change in mean serum hemoglobin A1c.
12 and 24 months
Change in Green-labeled (Healthy) Food Purchases
時間枠:12 and 24 months
Change in cafeteria food purchases labeled green.
12 and 24 months
Change in Red-labeled (Unhealthy) Food Purchases
時間枠:12 and 24 months
Change in cafeteria food purchases labeled red.
12 and 24 months
Change in Healthy Purchasing Score
時間枠:12 and 24 months
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).
12 and 24 months
Change in Healthy Eating Index Score-15
時間枠:12 and 24 months
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.
12 and 24 months

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2016年9月1日

一次修了 (実際)

2020年3月1日

研究の完了 (実際)

2020年3月15日

試験登録日

最初に提出

2016年1月18日

QC基準を満たした最初の提出物

2016年1月18日

最初の投稿 (見積もり)

2016年1月21日

学習記録の更新

投稿された最後の更新 (実際)

2021年12月1日

QC基準を満たした最後の更新が送信されました

2021年11月29日

最終確認日

2021年11月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • 5R01HL125486 (米国 NIH グラント/契約)
  • R01DK114735 (米国 NIH グラント/契約)

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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