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临床试验/NCT05485675
NCT05485675招募中不适用

Stand & Move at Work II: Effectiveness and Implementation of a Worksite Wellness Program

Arizona State University1 个研究点 分布在 1 个国家目标入组 4,800 人开始时间: 2022年10月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
4,800
试验地点
1
主要终点
Intervention Fidelity

研究概览

简要总结

This is a 2-arm group-randomized hybrid effectiveness-implementation (HEI type 2) study to test an evidence-based intervention (EBI) known as Stand & Move at Work(SMW) to reduce sedentary time in the workplace, and to test the role of expert facilitation (SMW+) for improving intervention fidelity.

详细描述

Primary Aim: To assess worksite-level reduction in sedentary time and intervention fidelity over 12 months Secondary Aim: To assess cost effectiveness of the intervention at 12 and 24 months

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Worksite-Level Inclusion Criteria:
  • •More than 80% of employees work full time (30+ hours per week).
  • •At least 45 employees in the worksite with sit-stand workstations working at least three days per week
  • •Occupations require primarily desk-based work (e.g., computer- and telephone-based)
  • •Willing to allow the researchers to distribute online research surveys to all employees in order to allow the program to be evaluated.
  • •Allow 30 randomly selected individuals to wear an activity monitor in several 7-day intervals across two years.
  • •Willing to be randomized to either intervention.
  • •Willing to identify one or more worksite champions to implement the Stand & Move at Work™ program.
  • •Worksite-level

排除标准

  • •Involved in previous interventions to reduce sitting and increase standing and moving at work in the last 24 months.
  • •Involved in the Stand and Move I intervention.
  • •Another worksite within the same organization is participating in the program and contamination across those worksites cannot be avoided.
  • •Employee-level inclusion criteria:
  • •18 years or older
  • •Willing to provide informed consent

研究组 & 干预措施

Stand & Move at Work

Active Comparator

Given an evidence-based workplace program to reduce sedentary behavior and increase standing and moving using a web-based platform. The web platform has a toolkit with strategies and guides for the worksite Champions to address changes at the environmental, social, and cultural levels.

干预措施: Stand & Move at Work (Behavioral)

Stand & Move at Work+

Experimental

This arm will receive access to the same web-based platform and toolkit as the other arm. Additionally, worksites in this arm will be assigned and expert facilitator who will meet regularly with the worksite Champions to assist with implementation.

干预措施: Stand & Move at Work+ (Behavioral)

结局指标

主要结局

Intervention Fidelity

时间窗: 24 months

A questionnaire-based assessment of intervention fidelity completed by study participants regarding the advocates (competence and adherence) through an online portal. SCORING RANGE

Researcher derived measures of fidelity

时间窗: 24 months

A single composite measure of directly-observed intervention delivery assessed via web analytics, participation rates, and other calculated measures of fidelity.

Changes in posture

时间窗: Baseline, 3 month, 12 months, and 24 months

Accelerometer-based (activPAL) sensor fixed to the thigh that measures sitting, standing, and lying down over 7 days.

Competence/Adherence

时间窗: 24 months

A questionnaire-based assessment of intervention fidelity completed by study champions (competence and adherence) through an online portal. Based on Likert-scales and interval scales. SCORING RANGE

Competence/Adherence

时间窗: 3 months

A questionnaire-based assessment of intervention fidelity completed by study champions (competence and adherence) through an online portal. Based on Likert-scales and interval scales. SCORING RANGE

Competence/Adherence

时间窗: 12 months

A questionnaire-based assessment of intervention fidelity completed by study champions (competence and adherence) through an online portal. Based on Likert-scales and interval scales. SCORING RANGE

Intervention Fidelity

时间窗: 3 months

A questionnaire-based assessment of intervention fidelity completed by study participants regarding the advocates (competence and adherence) through an online portal. SCORING RANGE

Intervention Fidelity

时间窗: 12 months

A questionnaire-based assessment of intervention fidelity completed by study participants regarding the advocates (competence and adherence) through an online portal. SCORING RANGE

Researcher derived measures of fidelity

时间窗: 3 months

A single composite measure of directly-observed intervention delivery assessed via web analytics, participation rates, and other calculated measures of fidelity.

Researcher derived measures of fidelity

时间窗: 12 months

A single composite measure of directly-observed intervention delivery assessed via web analytics, participation rates, and other calculated measures of fidelity.

次要结局

  • Comparison of program-related costs(Baseline, 3 month, 12 months, and 24 months.)
  • Change in health-related quality of life(Baseline, 3 month, 12 months, and 24 months.)
  • Change in musculoskeletal pain(Baseline, 3 months, 12 months, and 24 months.)
  • Change in Work Productivity and Activity Impairment Questionnaire - General Health(Baseline, 3 months, 12 months, and 24 months.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Matthew P Buman, PhD

Professor

Arizona State University

研究点 (1)

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