OverweightNCT02904486
Effectiveness of Modified Health Belief Model Based Intervention to Reduce Body Mass Index
A study testing change behavior in people with Overweight, run by Chulalongkorn University.
Trial summary
The purpose of this study is to Effectiveness of Modified Health Belief Model Based Intervention to Reduce Body Mass Index for Age in Overweight Junior High School Students. Read more about this study
- Who is it for?
- Ages 12 to 15 years
- Conditions the study is for
- Overweight
- What is being tested?
- change behavior
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 232 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Jul 2017
- 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 12 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- junior High School Students
- age 12 - 15 years
- bmi for age ≥ median +1 SD
- Read and write Thai Language
- Agree to participate voluntarily .
Who cannot join
- students with medical conditions diagnosed by a physician and a barrier to participation .
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effectiveness of Modified Health Belief Model Based Intervention to Reduce Body Mass
The purpose of this study is to Effectiveness of Modified Health Belief Model Based Intervention to Reduce Body Mass Index for Age in Overweight Junior High School Students.
Read the detailed description
The purpose of this study is to Effectiveness of Modified Health Belief Model Based Intervention to change behavior to Reduce Body Mass Index for Age in Overweight Junior High School Students.
- Conditions
- Overweight
- Being tested
- change behavior
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
change behaviorBehavioural
Also called change behavior intervention
Modified Health Belief Model Based Intervention to Reduce Body Mass Index for Age
| Study group | Role | What they receive |
|---|---|---|
| change behavior | Experimental | Modified Health Belief Model Based Intervention and study health topic in classroom to change behavior for Reduce Body Mass Index for Age in Overweight Junior High School Students. Receives: Behavioral: change behavior |
| lifestyle behavior | Experimental | study health topic in classroom to change behavior for Reduce Body Mass Index for Age in Overweight Junior High School Students. Receives: Behavioral: change behavior |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Mass Index
Modified Health Belief Model Based Intervention to Reduce Body Mass Index for Age in Overweight Junior High School Students durationof program 6 month
Measured: 6 month
Secondary outcomes (1)
Heath literacy for obesity in Junior High School Students.
assessment to Heath literacy for obesity in Junior High School Students by questionnaire.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2016 (estimated)
- Study startJan 2017
- Primary completionJan 2017 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by Chulalongkorn 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 232 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Waraporn Khumros, Chulalongkorn University
- Investigators
- waraporn khumros, Ph.D study, Principal investigator, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02904486
- Sponsor's protocol ID
- AUI-9959
- Status last verified
- Sep 2016
- First submitted
- 9 Sep 2016
- Last updated
- 19 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Modified Health Belief Model Based Intervention to Reduce Body Mass
- ClinicalTrials.gov ID
- NCT02904486
- Acronym / sponsor ID
- AUI-9959
- Conditions
- Overweight
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 232 participants (estimated)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 19 Sep 2016 (estimated)
- 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 purpose of this study is to Effectiveness of Modified Health Belief Model Based Intervention to Reduce Body Mass Index for Age in Overweight Junior High School Students.
Detailed description
The purpose of this study is to Effectiveness of Modified Health Belief Model Based Intervention to change behavior to Reduce Body Mass Index for Age in Overweight Junior High School Students.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| change behavior | Experimental | Behavioral: change behaviorModified Health Belief Model Based Intervention and study health topic in classroom to change behavior for Reduce Body Mass Index for Age in Overweight Junior High School Students. |
| lifestyle behavior | Experimental | Behavioral: change behaviorstudy health topic in classroom to change behavior for Reduce Body Mass Index for Age in Overweight Junior High School Students. |
Who may qualify
- Ages
- 12 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- junior High School Students
- age 12 - 15 years
- bmi for age ≥ median +1 SD
- Read and write Thai Language
- Agree to participate voluntarily .
Key exclusion criteria (1 listed)
- students with medical conditions diagnosed by a physician and a barrier to participation .
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 |
|---|---|---|
| change behaviorAlso: change behavior interventionModified Health Belief Model Based Intervention to Reduce Body Mass Index for Age | Behavioural | change behavior, lifestyle behavior |
Primary outcome
Body Mass Index
Time frame: 6 month
Modified Health Belief Model Based Intervention to Reduce Body Mass Index for Age in Overweight Junior High School Students durationof program 6 month
1 secondary outcome
Heath literacy for obesity in Junior High School Students.
Time frame: 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2016.
- Individual participant dataSharing planned: Yes
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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.
waraporn khumros, Ph.D study principal investigator
Chulalongkorn University
Questions about this trial
What is this clinical trial studying?
A study testing change behavior in people with Overweight, 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 5 inclusion and 1 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 19 Sep 2016. 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 waraporn khumros, Ph.D Candidate (668-73711369, wara_aui@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Mass Index (time frame: 6 month). 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 19 Sep 2016.