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临床试验/NCT07031726
NCT07031726已完成不适用

The Effectiveness of Worksite Nutrition and Wellness Program on Changes in Body Composition, Metabolic Profile, and Physical Fitness Among Employees

University of Brawijaya1 个研究点 分布在 1 个国家目标入组 98 人开始时间: 2025年6月12日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
98
试验地点
1
主要终点
Change in Body Mass Index (BMI)

研究概览

简要总结

This study aims to evaluate the effectiveness of a worksite-based nutrition and wellness program in improving body composition, metabolic profile, and physical fitness among university employees who are overweight or obese. The intervention includes personalized and structured physical activity (brisk walking), nutritional education, and self-monitoring using mobile applications. Participants will be assessed at baseline, after 6 weeks and 12 weeks of intervention to determine changes in fat mass, muscle mass, waist circumference, and related health indicators. This program is designed to promote healthier lifestyle habits and prevent non-communicable diseases in the workplace.

详细描述

This study is cluster randomized controlled trial conducted at Universitas Brawijaya to assess the effectiveness of a comprehensive workplace-based wellness intervention. The intervention comprises three key components: (1) structured physical activity is brisk walking with 150 minutes minimum for target per week; (2) personalized nutrition education delivered through interactive counseling; and (3) daily self-monitoring using a mobile application.

Participants include university employees categorized as overweight or obese, who work in sedentary office jobs for more than 5 hours per day. Subjects will be assessed at three time points-baseline, after 6 weeks, and after 12 weeks-to measure changes in body composition (e.g., body mass index, body fat percentage, subcutaneous fat, skeletal mass, and waist circumference), metabolic profile (e.g., fasting blood glucose and cholesterol), and physical fitness parameters.

The study aims to provide evidence on the impact of structured, low-cost wellness programs in reducing obesity-related health risks among adult employees in institutional settings. Ethical approval has been obtained from the Faculty of health, Universitas Brawijaya. The results are expected to support future implementation of health promotion policies in the workplace.

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
Single (Participant)

盲法说明

Participants were blinded to group assignment to reduce bias in self-reported outcomes and compliance. Investigators and outcome assessors were not blinded due to the nature of the intervention

入排标准

年龄范围
20 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Employees aged 20-40 years
  • BMI ≥ 23 kg/m²
  • Body fat percentage ≥ 25% as measured by body composition analysis
  • Employed in white-collar occupations with predominantly sedentary work activities, defined as sitting for ≥ 5 hours per day, based on results from the Global Physical Activity Questionnaire (GPAQ).
  • Not engaging in regular vigorous physical activity, defined as participating in such activity less than 3 times per week, according to GPAQ results.
  • Not having a medical condition that could inhibit participation in the intervention.
  • Be willing to attend the program for a full 12 weeks.

排除标准

  • A history of severe chronic disease, including type 1 diabetes, severe coronary heart disease, or kidney failure.
  • Be enrolled in other weight loss programs that may affect the results of the study.
  • Regular engagement in vigorous-intensity exercise prior to the start of the intervention program.
  • Not classified as a white-collar sedentary worker based on the Global Physical Activity Questionnaire (GPAQ) assessment.

研究组 & 干预措施

Worksite nutrition and wellness program

Experimental

Participants receive a 12-week worksite nutrition and wellness program in a university setting. Core components include: (1) nutrition education sessions on healthy diet and portion control, (2) workplace-based wellness support and behavior-change strategies (e.g., goal setting and self-monitoring), and (3) physical activity component [e.g., brisk walking program/weekly targets]. Delivery mode: [group sessions/online messaging/face-to-face], frequency: [e.g., weekly/biweekly], and adherence support: [e.g., reminders, tracking, incentives if used]. Outcomes are assessed at baseline and post-intervention [plus interim assessments if applicable].

干预措施: Worksite Nutrition and Wellness Program (Behavioral)

Standard Education Group

Active Comparator

Participants in this group will receive standard educational materials about nutrition and physical activity based on the official guidelines published by the Indonesian Ministry of Health. No structured or personalized intervention will be provided.

干预措施: Standard education (Behavioral)

结局指标

主要结局

Change in Body Mass Index (BMI)

时间窗: Baseline, Week 6, and Week 12

Change in BMI measured using standard anthropometric protocol

次要结局

  • Body Fat Percentage(At Baseline, Week 6, and Week 12)
  • Skeletal mass(Baseline, week 6, Week 12)
  • Change in Waist Circumference(Baseline, Week 6, Week 12)
  • Change in Hand Grip Strength(Baseline, Week 6, and Week 12)
  • Change in VO₂ Max(Baseline, Week 6, and Week 12)
  • Change in Fasting Blood Glucose(Baseline and Week 12)
  • Change in Total Blood Cholesterol(Baseline and Week 12)

研究者

发起方
University of Brawijaya
申办方类型
Other
责任方
Principal Investigator
主要研究者

Irka Dwi

Principal Investigator

University of Brawijaya

研究点 (1)

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