Effect of Nutrition and Wellness Program on Health Parameter Among Employees

NCT ID: NCT07031726

Last Updated: 2025-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

172 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-26

Study Completion Date

2025-09-21

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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 (such as Zumba classes), 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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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) personalized physical activity based on GPAQ and structured physical activity, including biweekly group Zumba sessions and home-based sessions using video guidance; (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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obesity Prevention Wellness Program Body Composition Nutrition Workplace Interventions

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants
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

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Worksite nutrition and wellness program

Participants in this group will receive a structured wellness program including personalized physical activity and Zumba classes twice per month, nutritional counseling, and daily step tracking using a mobile app.

Group Type EXPERIMENTAL

Worksite Nutrition and Wellness Program

Intervention Type BEHAVIORAL

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

Standard Education Group

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.

Group Type ACTIVE_COMPARATOR

Standard education

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Worksite Nutrition and Wellness Program

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

Intervention Type BEHAVIORAL

Standard education

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

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

WNWP personalized physical activity personalized nutrition

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Universiti Putra Malaysia

OTHER

Sponsor Role collaborator

Universiti Teknologi MARA (UiTM) Sungai Buloh Campus, Malaysia

UNKNOWN

Sponsor Role collaborator

University of Brawijaya

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Irka Dwi

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Irka Dwi Fatmawati, S.Tr. Gz.

Role: PRINCIPAL_INVESTIGATOR

University of Brawijaya

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Universitas Brawijaya - Kampus 2

Malang, East Java, Indonesia

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Indonesia

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Irka Dwi Fatmawati, S.Tr. Gz.

Role: CONTACT

+62 877-8932-3261

Nia Novita Wirawan, Dr., STP, M.Sc.

Role: CONTACT

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Irka Dwi Fatmawati, S.Tr. Gz.

Role: primary

+6287789323261

Nia Novita Wirawan, Dr., STP, M.Sc.

Role: backup

+628129674654

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

UBStar Internal Grant

Identifier Type: OTHER

Identifier Source: secondary_id

UBGizi2025WNWP01S2

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Positive Action for Today's Health
NCT01025726 COMPLETED NA
Sustaining Quality Physical Education for Healthy Kids
NCT07227935 ENROLLING_BY_INVITATION NA