NCT03975335

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
823

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 2, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2018

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 14, 2019

Completed
22 days until next milestone

First Posted

Study publicly available on registry

June 5, 2019

Completed
Last Updated

June 5, 2019

Status Verified

June 1, 2019

Enrollment Period

4 months

First QC Date

May 14, 2019

Last Update Submit

June 1, 2019

Conditions

Keywords

NCDsRisk behaviorsAdolescentsHealth education intervention

Outcome Measures

Primary Outcomes (3)

  • 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.

    Three months

  • 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.

    Three months

  • Change in practice

    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 Outcomes (2)

  • Body Mass Index (BMI)

    Three months

  • Blood Pressure

    Three months

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Behavioral: Health education

Control group

PLACEBO COMPARATOR

Control group received session on carrier guidance.

Other: Carrier Guidance

Interventions

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 group

Carrier opportunities and counselling

Control group

Eligibility Criteria

Age14 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • Physically disabled or having limited movement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chi Research & Infotec Ltd.

Dhaka, 1000, Bangladesh

Location

Related Publications (2)

  • 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.

MeSH Terms

Conditions

Risk-Taking

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Md Khalequzzaman, PhD

    Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

    PRINCIPAL INVESTIGATOR
  • Sohel Reza Choudhury, DrPH

    National Heart Foundation Hospital and Research Institute

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2019

First Posted

June 5, 2019

Study Start

May 2, 2018

Primary Completion

August 20, 2018

Study Completion

August 20, 2018

Last Updated

June 5, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

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

Locations