A Digital Health Program for Non-Communicable Disease Prevention in a Workplace Setting in Thailand

May 30, 2024 updated by: Zethapong Nimmanterdwong, MD, Chulalongkorn University

A Digital Health Program for Non-Communicable Disease Prevention in a Workplace Setting in Thailand: A Quasi-Experimental Study

The goal of this quasi-experimental study is to test the effectiveness of a digital health program designed to prevent non-communicable diseases (NCDs) in employees within a workplace setting in Thailand. The main questions it aims to answer are:

  • Can a digital health program help participants lose weight?
  • Does the digital health program improve other health outcomes such as Body Mass Index (BMI), blood lipid levels (triglycerides and LDL), blood sugar levels (HbA1c or fasting plasma glucose), and blood pressure? Is the digital health program feasible and acceptable in the Thai workplace setting, as measured by participation rates, usage, and participant satisfaction?

Participants will:

  • Attend four group health education sessions, each lasting one hour, scheduled over a six-month period.
  • Have unlimited access to individual chat consultations with a healthcare team, including doctors, dietitians, fitness coaches, and psychologists, available from 9:00 AM to 5:00 PM on workdays, excluding public holidays.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This quasi-experimental study titled "A Digital Health Program for Non-Communicable Disease Prevention in a Workplace Setting in Thailand" aims to evaluate the preliminary effectiveness of a digital health program in reducing weight among participants in a workplace setting. Conducted at Chulalongkorn Hospital, Bangkok, over a period of 1.5 years, the study focuses on the impact of the digital health program on various health outcomes, including Body Mass Index (BMI), blood lipid levels (triglycerides and LDL), blood sugar levels (HbA1c or fasting plasma glucose), and blood pressure. Additionally, it assesses the feasibility and acceptability of the program within the Thai workplace context, measured by participation rates, usage, and participant satisfaction.

The research adopts a single-arm quasi-experimental design to assess the weight loss efficacy of the digital health program aimed at preventing non-communicable diseases (NCDs) among employees at risk. The target population includes employees of the Faculty of Medicine, Chulalongkorn University, and/or Chulalongkorn Hospital, with an estimated sample size of 150 participants. Recruitment leverages employee health examination data, with informed consent obtained through comprehensive information sharing.

The intervention comprises four group health education sessions (1 hour each) and unlimited individual chat consultations during work hours, facilitated by a multidisciplinary team including doctors, dietitians, fitness coaches, and psychologists. Data collection spans six months, with a follow-up health examination at the six-month mark, coordinated by the Department of Preventive and Social Medicine, Chulalongkorn Hospital.

The research study conducted a series of educational sessions over six months, focusing on health goal setting, nutrition, physical fitness, psychological resilience, and health outcome evaluation. Here's a summary of the sessions conducted:

Health Goal Setting Lecture (Month 1): Participants learned about the importance of understanding their health, covering basics such as motivation for change, health risk assessment, introduction to the program's curriculum, and setting personal health goals using a realistic behavioral goal-setting framework.

Nutrition Lecture by a Dietitian (Month 2): This session introduced participants to creating a personalized eating plan and understanding individual nutrition. It explored topics like portion control and food selection, illustrated with successful case examples to demonstrate effective dietary strategies. The session concluded with the creation of a customizable eating plan and ongoing support through chat throughout the program.

Fitness Coaching Lecture (Month 3): A fitness coach introduced the appropriate amount, timing, and types of exercise, using successful case examples to show how to implement a real-life exercise plan. This laid the foundation for exercise plans aligned with health goals and encouraged participation in physical activities. The session ended with the creation of a tailored exercise plan and continuous modification support via chat throughout the program.

Psychology Lecture by a psychologist (Months 4-5): The session provided knowledge on coping plans for when goals are not met as intended, encouraging participants to develop their own coping strategies and build resilience. The importance of social support and resilience in maintaining healthy physical activities and eating habits to prevent reverting to old behaviors was emphasized. Participants were advised to review their health goals and received feedback on their physical and dietary practices.

Health Outcome Evaluation by a Doctor (Month 6): Participants met with a doctor for a scheduled physical examination six months after joining the research program. This included blood tests (6-12 milliliters, approximately 2 teaspoons) to assess laboratory results such as weight, Body Mass Index (BMI), lipid levels, blood sugar levels, and blood pressure.

All activities and processes are conducted remotely, utilizing digital platforms for both individual consultations and group training sessions. The study plans to tailor interventions to individual participants based on the Health Action Process Approach (HAPA), aiming for personalized behavior change support. Modifications to the trial, if any, will be documented upon completion. The trial's effectiveness and participant adherence will be assessed and recorded, ensuring a consistent approach throughout the program and documenting all digital platform interactions.

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Must have a Body Mass Index (BMI) indicating overweight, specifically between 23.0 and 27.5 kg/m². OR
  • Must have blood lipid levels indicating risk, such as triglyceride levels between 150 and 199 mg/dL or LDL levels between 160 and 189 mg/dL. OR
  • Must have blood sugar levels indicating a pre-diabetic state, such as an HbA1c level between 5.7% and 6.4% or fasting plasma glucose levels between 100 and 125 mg/dL. OR
  • Must have systolic blood pressure between 120 and 139 mmHg and/or diastolic blood pressure between 80 and 89 mmHg.
  • Must be able to read and communicate in Thai to participate in project activities.
  • Must have access to digital devices compatible with the digital health program, such as smartphones with operating systems equivalent to or higher than iOS 11 or Android 5.1, or computers capable of joining online seminars.
  • Must consent to participate in the research study.

Exclusion Criteria:

  • Pregnancy, bedridden state, or disability that limits mobility or the ability to exercise.
  • History of non-communicable diseases, such as heart disease, stroke, diabetes, or any acute illness.
  • Participation in a health program or weight loss program currently or in the previous month.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: The Intervention Arm

Participants will engage in various activities, including:

  • Attending four group health education sessions, each lasting one hour, over a six-month period.
  • Having access to individual chat consultations with a healthcare team, including doctors, dietitians, fitness coaches, and psychologists, available from 9:00 AM to 5:00 PM on workdays, excluding public holidays, with no limit on consultation times.
Behavioral: A Digital Health Program for Non-Communicable Disease Prevention in a Workplace Setting in Thailand
The program consists of two main components: (1) Participants are invited to join health courses and/or health activities in the form of seminars or group activities, and (2) Participants will have access to an application that is part of the program, where they can consult with health experts to plan lifestyle modifications and reduce behavioral risk factors over the 6-month duration of the research project, totaling four sessions, each lasting one hour.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight
Time Frame: 6 months
To assess weight reduction.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BMI
Time Frame: 6 months
To assess BMI change.
6 months
Total cholesterol
Time Frame: 6 months
To assess total cholesterol change.
6 months
Triglycerides
Time Frame: 6 months
To assess triglycerides change.
6 months
HDL
Time Frame: 6 months
To assess HDL change.
6 months
LDL
Time Frame: 6 months
To assess LDL change.
6 months
HbA1c
Time Frame: 6 months
To assess HbA1c change.
6 months
Fasting plasma glucose
Time Frame: 6 months
To assess fasting plasma glucose change.
6 months
blood pressure
Time Frame: 6 months
To assess blood pressure change.
6 months
Feasibility (number of consented participants to all eligible participants ratio)
Time Frame: 3 months (recruitment period)
number of consented participants to all eligible participants ratio
3 months (recruitment period)
Acceptability
Time Frame: 6 months
Net Promoter Score assessed by 1 verbal question at the end of the intervention.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chulalongkorn University

Investigators

  • Principal Investigator: Jate Ratanachina, MD MSc PhD, Chulalongkorn University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2024

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

September 1, 2025

Study Registration Dates

First Submitted

February 12, 2024

First Submitted That Met QC Criteria

February 12, 2024

First Posted (Actual)

February 20, 2024

Study Record Updates

Last Update Posted (Actual)

May 31, 2024

Last Update Submitted That Met QC Criteria

May 30, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 66701100301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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