- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03975335
Reducing Behavioral Risk Factors of NCDs: Protocol for a School-based Health Education Program in Bangladesh
An Intervention Program to Reduce NCD Related Behavioral Risk Factor Among Adolescents in Institutional Settings of Bangladesh
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Dhaka, Bangladesh, 1000
- Chi Research & Infotec Ltd.
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
• Practicing at least two risk behaviors from three- unhealthy diet, physical inactivity and smoking
Exclusion Criteria:
• Physically disabled or having limited movement
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Intervention group
Health education on NCDs and behavioral risk factors was delivered through motivation and observational learning session.
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In this health education intervention, emphasis is given on evoking adolescents' internal desire to change, supporting self-efficacy to be changed, guiding self-regulatory ways along with facilitating desired changing process by empowering them with choices and skills.
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PLACEBO_COMPARATOR: Control group
Control group received session on carrier guidance.
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Carrier opportunities and counselling
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in knowledge
Time Frame: Three months
|
Knowledge about non-communicable diseases related risk behaviors such as dietary habit, physical activity, smoking and alcohol will be measured by 25 knowledge measuring questions scoring 54 in total.
Answer to the questions will be regarded as correct or incorrect based on information from standard medical textbooks and guidelines.
Difference of knowledge score from pre-intervention to post-intervention survey will be measured.
|
Three months
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Change in attitude
Time Frame: Three months
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Attitude towards the risk behaviors- dietary habit, physical activity, smoking and alcohol will be measured by nine attitude measuring questions in a Likert Scale ranging from one to three.
Change in attitude score from pre-intervention to post-intervention survey will be measured.
|
Three months
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Change in practice
Time Frame: Three months
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Practice will be measured as follows-
Change in practice from pre-intervention to post-intervention survey will be measured. |
Three months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Body Mass Index (BMI)
Time Frame: Three months
|
The ratio of body weight in kilogram and the height in meter square will be considered as BMI.
Classification of BMI will be done as following- Underweight (Less than 18.5); Normal weight (18.5-24.9);
Overweight (25.0-29.9)
and Obese (More than 30.0)
|
Three months
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Blood Pressure
Time Frame: Three months
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Blood pressure will be measured by an automatic digital sphygmomanometer (HEM-8712, Omron, Kyoto, Japan).
Presence of systolic blood pressure ≥ 130 mm of Hg and/or diastolic blood pressure ≥ 80 mm of Hg will be considered as having high blood pressure.
|
Three months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Md Khalequzzaman, PhD, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
- Study Director: Sohel Reza Choudhury, DrPH, National Heart Foundation Hospital and Research Institute
Publications and helpful links
General Publications
- Salwa M, Subaita F, Choudhury SR, Khalequzzaman M, Al Mamun MA, Bhuiyan MR, Haque MA. Fruit and vegetables consumption among school-going adolescents: Findings from the baseline survey of an intervention program in a semi-urban area of Dhaka, Bangladesh. PLoS One. 2021 Jun 8;16(6):e0252297. doi: 10.1371/journal.pone.0252297. eCollection 2021.
- Salwa M, Atiqul Haque M, Khalequzzaman M, Al Mamun MA, Bhuiyan MR, Choudhury SR. Towards reducing behavioral risk factors of non-communicable diseases among adolescents: protocol for a school-based health education program in Bangladesh. BMC Public Health. 2019 Jul 25;19(1):1002. doi: 10.1186/s12889-019-7229-8.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BSMMU/2018/5958
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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