ObesityNCT05873140
Healthy Thai Project With Bangkoknoi Model: Fatless Community
A study testing application LINE in people with Obesity, run by Mahidol University at 1 site in Thailand.
Trial summary
The goal of this interventional study is to make people in a community realize negative effects of obesity on health, and how to tackle it by adopting a lifestyle modification for weight reduction. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- application LINE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteThailand
- Study dates
- 26 Jun 2022to 2 Apr 2023
- 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
- Obesity (BMI ≥ 25 kg/m2)
- Waist circumference ≥ 80 cm in women and ≥ 90 cm in men
Who cannot join
- Contraindications for bioelectrical impedance analysis
- Active cancer
- No available health data
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty of Medicine Siriraj Hospital
Bangkoknoi, Bangkok, 10700
About this study
The goal of this interventional study is to make people in a community realize negative effects of obesity on health, and how to tackle it by adopting a lifestyle modification for weight reduction. Adults aged 20 years old or more with obesity (BMI ≥ 25 kg/m2) or waist circumference ≥ 80 cm in women and ≥ 90 cm in men were recruited. All participants received an educational session of lifestyle modification for weight reduction on the first day of study. Participants were then assigned to either continuously receive education (video clips and infographics) via application LINE, or no further education. The main questions it aims to answer are:
- Whether or not an educational session of lifestyle modification leads to weight reduction.
- Whether or not a weight loss by a continuous education via an online application is more effective than not receiving it.
- Conditions
- Obesity
- Being tested
- application LINE
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
application LINEBehavioural
Online lifestyle modification education for weight loss
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Continuously receiving education (video clips and infographics) via application LINE Receives: Behavioral: application LINE |
| Control group | No intervention | No application LINE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight change
Body weight change
Measured: 6 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2023
- Study start26 Jun 2022
- Primary completion2 Apr 2023
- Study completion2 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Phunchai Charatcharoenwitthaya, Mahidol University
- Investigators
- Phunchai Charatcharoenwitthaya, MD, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05873140
- Sponsor's protocol ID
- Si 1000/2021
- Status last verified
- Jun 2023
- First submitted
- 15 May 2023
- Last updated
- 3 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Thai Project With Bangkoknoi Model: Fatless Community
- ClinicalTrials.gov ID
- NCT05873140
- Acronym / sponsor ID
- Si 1000/2021
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 26 Jun 2022 (actual)
- Primary completion
- 2 Apr 2023 (actual)
- Study completion
- 2 Apr 2023 (actual)
- First posted
- 24 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this interventional study is to make people in a community realize negative effects of obesity on health, and how to tackle it by adopting a lifestyle modification for weight reduction. Adults aged 20 years old or more with obesity (BMI ≥ 25 kg/m2) or waist circumference ≥ 80 cm in women and ≥ 90 cm in men were recruited. All participants received an educational session of lifestyle modification for weight reduction on the first day of study. Participants were then assigned to either continuously receive education (video clips and infographics) via application LINE, or no further education. The main questions it aims to answer are:
- Whether or not an educational session of lifestyle modification leads to weight reduction.
- Whether or not a weight loss by a continuous education via an online application is more effective than not receiving it.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Behavioral: application LINEContinuously receiving education (video clips and infographics) via application LINE |
| Control group | No intervention | –No application LINE |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Obesity (BMI ≥ 25 kg/m2)
- Waist circumference ≥ 80 cm in women and ≥ 90 cm in men
Key exclusion criteria (3 listed)
- Contraindications for bioelectrical impedance analysis
- Active cancer
- No available health data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| application LINEOnline lifestyle modification education for weight loss | Behavioural | Study group |
Primary outcome
Body weight change
Time frame: 6 months after intervention
Body weight change
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Phunchai Charatcharoenwitthaya, MD principal investigator
Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing application LINE in people with Obesity, run by Mahidol University at 1 site in Thailand.
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 2 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: finished, as of the sponsor's last update on 3 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body weight change (time frame: 6 months after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jul 2023.