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

2021년 11월 29일 업데이트: 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.

연구 개요

상세 설명

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.

연구 유형

중재적

등록 (실제)

602

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

    • Massachusetts
      • Boston, Massachusetts, 미국, 02114
        • Massachusetts General Hospital

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

21년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 방지
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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)
간섭 없음: Control
Monthly letters with general nutrition information

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Weight Change
기간: 12 months
Change in weight from baseline to 12 months
12 months

2차 결과 측정

결과 측정
측정값 설명
기간
Weight Change
기간: 24 months
Change in weight from baseline to 24 months
24 months
Change in Blood Pressure
기간: 12 and 24 months
Change from baseline in mean systolic and diastolic blood pressure (BP).
12 and 24 months
Change in Total Cholesterol
기간: 12 and 24 months
Change from baseline in mean serum total cholesterol.
12 and 24 months
Change in LDL Cholesterol
기간: 12 and 24 months
Change from baseline in mean serum LDL.
12 and 24 months
Change in Triglycerides
기간: 12 and 24 months
Change in mean serum triglycerides.
12 and 24 months
Change in HDL Cholesterol
기간: 12 and 24 months
Change in mean serum HDL.
12 and 24 months
Change in Hemoglobin A1C
기간: 12 and 24 months
Change in mean serum hemoglobin A1c.
12 and 24 months
Change in Green-labeled (Healthy) Food Purchases
기간: 12 and 24 months
Change in cafeteria food purchases labeled green.
12 and 24 months
Change in Red-labeled (Unhealthy) Food Purchases
기간: 12 and 24 months
Change in cafeteria food purchases labeled red.
12 and 24 months
Change in Healthy Purchasing Score
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2016년 9월 1일

기본 완료 (실제)

2020년 3월 1일

연구 완료 (실제)

2020년 3월 15일

연구 등록 날짜

최초 제출

2016년 1월 18일

QC 기준을 충족하는 최초 제출

2016년 1월 18일

처음 게시됨 (추정)

2016년 1월 21일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2021년 12월 1일

QC 기준을 충족하는 마지막 업데이트 제출

2021년 11월 29일

마지막으로 확인됨

2021년 11월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • 5R01HL125486 (미국 NIH 보조금/계약)
  • R01DK114735 (미국 NIH 보조금/계약)

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

Personalized nutrition feedback에 대한 임상 시험

구독하다