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Chronic DiseaseNCT06265662

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

A study testing A Digital Health Program for Non-Communicable Disease Prevention in a Workplace Setting in Thailand in people with Chronic Disease and Noncommunicable Diseases, run by Chulalongkorn University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Chronic Disease, Noncommunicable Diseases
What is being tested?
A Digital Health Program for Non-Communicable Disease Prevention in a Workplace Setting in Thailand
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
No sites listed yet
Study dates
Jun 2024to Sep 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

No sites are listed yet.

Zethapong Nimmanterdwong, MD contact

(+66)22527864

zethapong@gmail.com

About this study

Official title: 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?
Read more

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.
Read the 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.

Being tested
A Digital Health Program for Non-Communicable Disease Prevention in a Workplace Setting in Thailand
Keywords
Mobile Health, Self Care, Workplace, Health Promotion, Digital Medicine
Medical subject headings
Chronic Disease, Noncommunicable Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    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.

Study groups in NCT06265662
Study groupRoleWhat they receive
The Intervention ArmExperimentalParticipants 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.
Receives: Behavioral: A Digital Health Program for Non-Communicable Disease Prevention in a Workplace Setting in Thailand

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Weight

    To assess weight reduction.

    Measured: 6 months

Secondary outcomes (10)
  1. BMI

    To assess BMI change.

    Measured: 6 months

  2. Total cholesterol

    To assess total cholesterol change.

    Measured: 6 months

  3. Triglycerides

    To assess triglycerides change.

    Measured: 6 months

  4. HDL

    To assess HDL change.

    Measured: 6 months

  5. LDL

    To assess LDL change.

    Measured: 6 months

  6. HbA1c

    To assess HbA1c change.

    Measured: 6 months

  7. Fasting plasma glucose

    To assess fasting plasma glucose change.

    Measured: 6 months

  8. blood pressure

    To assess blood pressure change.

    Measured: 6 months

  9. Feasibility (number of consented participants to all eligible participants ratio)

    number of consented participants to all eligible participants ratio

    Measured: 3 months (recruitment period)

  10. Acceptability

    Net Promoter Score assessed by 1 verbal question at the end of the intervention.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Feb 2024
  2. Study startJun 2024 (estimated)
  3. Primary completionSep 2025 (estimated)
  4. Study completionSep 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
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.
Masking
None (open label)
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06265662
Sponsor's protocol ID
66701100301
Status last verified
May 2024
First submitted
12 Feb 2024
Last updated
31 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • กลุ่มเทคโนโลยี ระบาดวิทยา และมาตรการชุมชน กองโรคไม่ติดต่อ กรมควบคุมโรค กระทรวงสาธารณสุข. รายงานสถานการณ์โรค NCDs เบาหวาน ความดันโลหิตสูง และปัจจัยเสี่ยงที่เกี่ยวข้อง. 2020.

  • คณะกรรมการเศรษฐกิจและสังคมแห่งเอเชียและแปซิฟิก. เหตุผลสนับสนุนการลงทุนใน มาตรการป้องกันและควบคุมโรคไม่ติดต่อในประเทศไทย. 2021.

  • มูลนิธิสถาบันวิจัยและพัฒนาผู้สูงอายุไทย. สถานการณ์ผู้สูงอายุไทย พ.ศ. 2564. 2021.

  • World Health Organization. Noncommunicable diseases. Fact sheets 2023 16 September 2023 [cited 2023 16 November 2023]; Available from: https://www.who.int/news-room/fact-sheets/detail/noncommunicable-diseases.

  • Burton, J. WHO healthy workplace framework and model: background and supporting literature and practices. 2010: Geneva.

  • World Health Organization. World mental health report: transforming mental health for all. 2022: Geneva.

  • World Health Organization. The impact of the COVID-19 pandemic on noncommunicable disease resources and services: results of a rapid assessment. 2020.

  • วารณี บุญช่วยเหลือ, ทิพาพร พงษ์เมษา, และ กมลภัทร ไชยกิตติโสภน. การดําเนินงานลดเสี่ยงต่อโรคหัวใจและหลอดเลือดในกลุ่มวัยทํางาน ที่มีความคุ้มค่าหรือมีประสิทธิผล ในชุมชน สถานบริการสุขภาพและสถานที่ทํางาน. 2018.

  • World Health Organization. Global Strategy on Diet, Physical Activity and Health. 2004, World Health Organization: Global Strategy on Diet, Physical Activity and Health.

  • World Health Organization. Preventing Non Communicable Diseases in the Workplace through Diet and Physical Activity. 2008, World Health Organization, Geneva: WHO/World Economic Forum Report of a Joint Event.

  • Proper KI, van Oostrom SH. The effectiveness of workplace health promotion interventions on physical and mental health outcomes - a systematic review of reviews. Scand J Work Environ Health. 2019 Nov 1;45(6):546-559. doi: 10.5271/sjweh.3833. Epub 2019 May 28.

    PubMed 31134284
  • Hafez D, Fedewa A, Moran M, O'Brien M, Ackermann R, Kullgren JT. Workplace Interventions to Prevent Type 2 Diabetes Mellitus: a Narrative Review. Curr Diab Rep. 2017 Feb;17(2):9. doi: 10.1007/s11892-017-0840-0.

    PubMed 28150162
  • Schwarz PEH, Timpel P, Harst L, Greaves CJ, Ali MK, Lambert J, Weber MB, Almedawar MM, Morawietz H. Blood Sugar Regulation for Cardiovascular Health Promotion and Disease Prevention: JACC Health Promotion Series. J Am Coll Cardiol. 2018 Oct 9;72(15):1829-1844. doi: 10.1016/j.jacc.2018.07.081.

    PubMed 30286928
  • Cannon MJ, Ng BP, Lloyd K, Reynolds J, Ely EK. Delivering the National Diabetes Prevention Program: Assessment of Enrollment in In-Person and Virtual Organizations. J Diabetes Res. 2022 Feb 1;2022:2942918. doi: 10.1155/2022/2942918. eCollection 2022.

    PubMed 35118160
  • Moungngern Y, S.S., Teparak P, Sriwijitkamol A. Effects of a Health Promotion Program Conducted by Nurses on Stabilization of HbA1C in Subjects at Risk for Diabetes: A Phase III Randomized Controlled Trial. J Med Assoc Thai, 2018. 101(10): p. 1343-8.

Questions about this trial

What is this clinical trial studying?

A study testing A Digital Health Program for Non-Communicable Disease Prevention in a Workplace Setting in Thailand in people with Chronic Disease and Noncommunicable Diseases, run by Chulalongkorn University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 31 May 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Zethapong Nimmanterdwong, MD ((+66)22527864, zethapong@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Weight (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06265662, which also lists 30 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2024.

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