NCT06265662

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2024

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 12, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 20, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

May 31, 2024

Status Verified

May 1, 2024

Enrollment Period

1.3 years

First QC Date

February 12, 2024

Last Update Submit

May 30, 2024

Conditions

Keywords

Mobile HealthSelf CareWorkplaceHealth PromotionDigital Medicine

Outcome Measures

Primary Outcomes (1)

  • Weight

    To assess weight reduction.

    6 months

Secondary Outcomes (10)

  • BMI

    6 months

  • Total cholesterol

    6 months

  • Triglycerides

    6 months

  • HDL

    6 months

  • LDL

    6 months

  • +5 more secondary outcomes

Study Arms (1)

The Intervention Arm

EXPERIMENTAL

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

Interventions

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.

The Intervention Arm

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (30)

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

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

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

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    PMID: 31134284BACKGROUND
  • 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.

    PMID: 28150162BACKGROUND
  • 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.

    PMID: 30286928BACKGROUND
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    PMID: 35118160BACKGROUND
  • 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.

    BACKGROUND
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    PMID: 24652723BACKGROUND
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    PMID: 32269830BACKGROUND
  • World Health Organization. Self-care interventions for health. Self-care interventions for health 2022 [cited 2023 19 November 2023]; Available from: https://www.who.int/news-room/fact-sheets/detail/self-care-health-interventions.

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    PMID: 11368702BACKGROUND
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MeSH Terms

Conditions

Chronic DiseaseNoncommunicable Diseases

Interventions

Tacrine

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AminoacridinesAcridinesHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Jate Ratanachina, MD MSc PhD

    Chulalongkorn University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zethapong Nimmanterdwong, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Student

Study Record Dates

First Submitted

February 12, 2024

First Posted

February 20, 2024

Study Start

June 1, 2024

Primary Completion

September 1, 2025

Study Completion

September 1, 2025

Last Updated

May 31, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share