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

June 1, 2019 updated by: Chi Research & Infotec Ltd.

An Intervention Program to Reduce NCD Related Behavioral Risk Factor Among Adolescents in Institutional Settings of Bangladesh

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

823

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Dhaka, Bangladesh, 1000
        • Chi Research & Infotec Ltd.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
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.
PLACEBO_COMPARATOR: Control group
Control group received session on carrier guidance.
Carrier opportunities and counselling

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
Change in attitude
Time Frame: Three months
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
Change in practice
Time Frame: Three months

Practice will be measured as follows-

  1. 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

  2. Physical activity: Not meeting 60 minutes physical activity of moderate intensity per day will be regarded as physically inactive.
  3. 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.

Three months

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
Blood Pressure
Time Frame: Three months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 2, 2018

Primary Completion (ACTUAL)

August 20, 2018

Study Completion (ACTUAL)

August 20, 2018

Study Registration Dates

First Submitted

May 14, 2019

First Submitted That Met QC Criteria

June 1, 2019

First Posted (ACTUAL)

June 5, 2019

Study Record Updates

Last Update Posted (ACTUAL)

June 5, 2019

Last Update Submitted That Met QC Criteria

June 1, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • BSMMU/2018/5958

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Study protocol, statistical analysis plan and informed consent form will be shared through

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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