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Reducing Behavioral Risk Factors of NCDs: Protocol for a School-based Health Education Program in Bangladesh

Primary Purpose

Non-communicable Disease Risk Factors

Status
Completed
Phase
Not Applicable
Locations
Bangladesh
Study Type
Interventional
Intervention
Health education
Carrier Guidance
Sponsored by
Chi Research & Infotec Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Non-communicable Disease Risk Factors focused on measuring NCDs, Risk behaviors, Adolescents, Health education intervention

Eligibility Criteria

14 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

• Practicing at least two risk behaviors from three- unhealthy diet, physical inactivity and smoking

Exclusion Criteria:

• Physically disabled or having limited movement

Sites / Locations

  • Chi Research & Infotec Ltd.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intervention group

Control group

Arm Description

Health education on NCDs and behavioral risk factors was delivered through motivation and observational learning session.

Control group received session on carrier guidance.

Outcomes

Primary Outcome Measures

Change in knowledge
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.
Change in attitude
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.
Change in practice
Practice will be measured as follows- Dietary habit: Presence of at least two of the following four habits will be accounted as having dietary risk behavior. i. Inadequate fruit consumption: Less than five servings of fruits per day ii. Inadequate vegetable consumption: Less than five servings of vegetables per day iii. Excessive salt consumption: Taking extra or raw salt during every meal iv. Sugar Sweetened Beverage (SSB) consumption: Consuming SSB more than three days per week Physical activity: Not meeting 60 minutes physical activity of moderate intensity per day will be regarded as physically inactive. Smoking and alcohol: Smoking regularly in the last 30 days or exposing to passive smoking more than three days per week will be accounted as in risk of smoking. Any amount of alcohol intake or any substance abuse in the last 30 days will be regarded as at risk. Change in practice from pre-intervention to post-intervention survey will be measured.

Secondary Outcome Measures

Body Mass Index (BMI)
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)
Blood Pressure
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.

Full Information

First Posted
May 14, 2019
Last Updated
June 1, 2019
Sponsor
Chi Research & Infotec Ltd.
Collaborators
Directorate General of Health Services
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1. Study Identification

Unique Protocol Identification Number
NCT03975335
Brief Title
Reducing Behavioral Risk Factors of NCDs: Protocol for a School-based Health Education Program in Bangladesh
Official Title
An Intervention Program to Reduce NCD Related Behavioral Risk Factor Among Adolescents in Institutional Settings of Bangladesh
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
May 2, 2018 (Actual)
Primary Completion Date
August 20, 2018 (Actual)
Study Completion Date
August 20, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chi Research & Infotec Ltd.
Collaborators
Directorate General of Health Services

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a before-after designed intervention study conducted in two randomly selected secondary schools- one was selected randomly as intervention school and the another as control school. A baseline survey was conducted among the students of both schools by a pre-tested questionnaire to attain their current status of knowledge, attitude and practices related to NCDs. Afterward, students were enrolled in the intervention group who met the eligibility criteria from the intervention school. The intervention was given through a health promotion session to a group of students, not more than 25 at a time, by trained facilitators. A post-intervention end line survey was conducted among all the participants from both schools using the same questionnaire three months after the baseline survey. An intervention has been developed based on some principals of two psychosocial theory- Motivational Interview and Social Cognitive Theory. Emphasis was given on motivating the adolescents towards a healthy lifestyle, supporting self-efficacy to be changed, guiding self-regulatory ways along with facilitating desired changing process by empowering them with choices about the preventive measures of NCDs. This intervention is expected to increase awareness by equipping the adolescents with specific knowledge and skills and thus, facilitate an eventual change in their practiced risk behaviors.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-communicable Disease Risk Factors
Keywords
NCDs, Risk behaviors, Adolescents, Health education intervention

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
823 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Health education on NCDs and behavioral risk factors was delivered through motivation and observational learning session.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Control group received session on carrier guidance.
Intervention Type
Behavioral
Intervention Name(s)
Health education
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Carrier Guidance
Intervention Description
Carrier opportunities and counselling
Primary Outcome Measure Information:
Title
Change in knowledge
Description
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.
Time Frame
Three months
Title
Change in attitude
Description
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.
Time Frame
Three months
Title
Change in practice
Description
Practice will be measured as follows- Dietary habit: Presence of at least two of the following four habits will be accounted as having dietary risk behavior. i. Inadequate fruit consumption: Less than five servings of fruits per day ii. Inadequate vegetable consumption: Less than five servings of vegetables per day iii. Excessive salt consumption: Taking extra or raw salt during every meal iv. Sugar Sweetened Beverage (SSB) consumption: Consuming SSB more than three days per week Physical activity: Not meeting 60 minutes physical activity of moderate intensity per day will be regarded as physically inactive. Smoking and alcohol: Smoking regularly in the last 30 days or exposing to passive smoking more than three days per week will be accounted as in risk of smoking. Any amount of alcohol intake or any substance abuse in the last 30 days will be regarded as at risk. Change in practice from pre-intervention to post-intervention survey will be measured.
Time Frame
Three months
Secondary Outcome Measure Information:
Title
Body Mass Index (BMI)
Description
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)
Time Frame
Three months
Title
Blood Pressure
Description
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.
Time Frame
Three months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: • Practicing at least two risk behaviors from three- unhealthy diet, physical inactivity and smoking Exclusion Criteria: • Physically disabled or having limited movement
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Md Khalequzzaman, PhD
Organizational Affiliation
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sohel Reza Choudhury, DrPH
Organizational Affiliation
National Heart Foundation Hospital and Research Institute
Official's Role
Study Director
Facility Information:
Facility Name
Chi Research & Infotec Ltd.
City
Dhaka
ZIP/Postal Code
1000
Country
Bangladesh

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Study protocol, statistical analysis plan and informed consent form will be shared through
Citations:
PubMed Identifier
34101740
Citation
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.
Results Reference
derived
PubMed Identifier
31345186
Citation
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.
Results Reference
derived

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Reducing Behavioral Risk Factors of NCDs: Protocol for a School-based Health Education Program in Bangladesh

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