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Non-communicable Disease Risk FactorsNCT03975335

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

A study testing Health education and Carrier Guidance in people with Non-communicable Disease Risk Factors, run by Chi Research & Infotec Ltd. at 1 site in Bangladesh.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 14 to 18 yearsHealthy volunteers can take part
Conditions the study is for
Non-communicable Disease Risk Factors
What is being tested?
Health education and Carrier Guidance
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
823 participants
Where
1 siteBangladesh
Study dates
2 May 2018to 20 Aug 2018
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 14 to 18 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

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

Who cannot join

  • Physically disabled or having limited movement

Trial locations and contacts

1 site in 1 country.

Bangladesh1 site

  • Chi Research & Infotec Ltd.

    Dhaka, 1000

Other trials in Bangladesh

About this study

Official title: 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.

Being tested
Health education, Carrier Guidance
Keywords
NCDs, Risk behaviors, Adolescents, Health education intervention
Medical subject headings
Risk-Taking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Health educationBehavioural

    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.

  • Carrier GuidanceOther

    Carrier opportunities and counselling

Study groups in NCT03975335
Study groupRoleWhat they receive
Intervention groupExperimentalHealth education on NCDs and behavioral risk factors was delivered through motivation and observational learning session.
Receives: Behavioral: Health education
Control groupPlacebo comparatorControl group received session on carrier guidance.
Receives: Other: Carrier Guidance

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Three months

  2. 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.

    Measured: Three months

  3. 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.
    2. 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
    3. Physical activity: Not meeting 60 minutes physical activity of moderate intensity per day will be regarded as physically inactive.
    4. 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.

    Measured: Three months

Secondary outcomes (2)

  1. 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)

    Measured: Three months

  2. 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.

    Measured: Three months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jun 2019
  2. Study start2 May 2018
  3. Primary completion20 Aug 2018
  4. Study completion20 Aug 2018

Resources

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
823 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03975335
Sponsor's protocol ID
BSMMU/2018/5958
Status last verified
Jun 2019
First submitted
14 May 2019
Last updated
5 Jun 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Study protocol, statistical analysis plan and informed consent form will be shared through

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.

    PubMed 34101740

  • 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.

    PubMed 31345186

Questions about this trial

What is this clinical trial studying?

A study testing Health education and Carrier Guidance in people with Non-communicable Disease Risk Factors, run by Chi Research & Infotec Ltd. at 1 site in Bangladesh.

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 1 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: finished, as of the sponsor's last update on 5 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in knowledge (time frame: Three months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03975335, which also lists 2 linked publications.

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 5 Jun 2019.

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