Effect of Nutrition and Wellness Program on Health Parameter Among Employees

NCT07031726 | Completed

• 2 other identifiers: UBGizi2025WNWP01S2UBStar Internal Grant
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity Prevention; Wellness Program; Body Composition; Nutrition; Workplace Interventions

Keywords

worksite wellness program; obesity prevention; personalized physical activity; personalized nutrition; employee health

Outcome Measures

Primary Outcomes (1)

• Change in Body Mass Index (BMI)

  Change in BMI measured using standard anthropometric protocol

  Baseline, Week 6, and Week 12

Secondary Outcomes (7)

• 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

Study Arms (2)

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 \[plus interim assessments if applicable\].

Behavioral: Worksite Nutrition and Wellness Program

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.

Behavioral: Standard education

Interventions

Worksite Nutrition and Wellness Program BEHAVIORAL

A structured behavioral intervention combining personalized physical activity and structured physical activity (Zumba classes), personalized nutrition counseling, and mobile app-based self-monitoring.

Also known as: WNWP, personalized physical activity, personalized nutrition

Worksite nutrition and wellness program

Standard education BEHAVIORAL

General educational materials on healthy eating and physical activity based on the Ministry of Health guidelines. No tailored or active intervention provided.

Standard Education Group

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Brawijaya: lead
• Universiti Teknologi MARA (UiTM) Sungai Buloh Campus, Malaysia: collaborator
• Universiti Putra Malaysia: collaborator

Study Sites (1)

Universitas Brawijaya - Kampus 2

Malang, East Java, 65145, Indonesia

Location

MeSH Terms

Interventions

Health Promotion

Intervention Hierarchy (Ancestors)

Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Irka Dwi Fatmawati, S.Tr. Gz.

  University of Brawijaya

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants will be assigned to different groups based on faculty divisions using a cluster allocation model. Each group will receive either a structured wellness program or usual care.

Study Record Dates

• First Submitted: May 24, 2025
• First Posted: June 22, 2025
• Study Start: June 12, 2025
• Primary Completion: October 2, 2025
• Study Completion: November 30, 2025
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: The data will be available beginning 6 months after study completion and will remain accessible for up to 3 years.
• Access Criteria: Access will be granted to qualified researchers upon reasonable request. The data will be shared in de-identified format via secure email or institutional data repository, pending ethical approval and data use agreement.

Locations

ID (1)