Clinical trial NCT06265662: A Digital Health Program for Non-Communicable Disease Prevention in a Workplace Setting in Thailand
Official title: A Digital Health Program for Non-Communicable Disease Prevention in a Workplace Setting in Thailand: A Quasi-Experimental Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chronic Disease
Noncommunicable Diseases
Keywords: Mobile Health
Self Care
Workplace
Health Promotion
Digital Medicine
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2024-02-20
Enrollment: 150
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single-arm quasi-experimental study for evaluating the effectiveness of a digital health program in weight reduction for the prevention of non-communicable diseases in the Thai workplace setting.
Primary purpose: PREVENTION

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Weight
timeFrame: 6 months
Secondary outcomes:
measure: BMI
timeFrame: 6 months
measure: Total cholesterol
timeFrame: 6 months
measure: Triglycerides
timeFrame: 6 months
measure: HDL
timeFrame: 6 months
measure: LDL
timeFrame: 6 months
measure: HbA1c
timeFrame: 6 months
measure: Fasting plasma glucose
timeFrame: 6 months
measure: blood pressure
timeFrame: 6 months
measure: Feasibility (number of consented participants to all eligible participants ratio)
timeFrame: 3 months (recruitment period)
measure: Acceptability
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Chulalongkorn University
name: Jate Ratanachina, MD MSc PhD
role: PRINCIPAL_INVESTIGATOR
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