Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03975335
Recruitment Status : Completed
First Posted : June 5, 2019
Last Update Posted : June 5, 2019
Sponsor:
Collaborator:
Directorate General of Health Services
Information provided by (Responsible Party):
Chi Research & Infotec Ltd.

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.

Condition or disease Intervention/treatment Phase
Non-communicable Disease Risk Factors Behavioral: Health education Other: Carrier Guidance Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 823 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: An Intervention Program to Reduce NCD Related Behavioral Risk Factor Among Adolescents in Institutional Settings of Bangladesh
Actual Study Start Date : May 2, 2018
Actual Primary Completion Date : August 20, 2018
Actual Study Completion Date : August 20, 2018

Arm Intervention/treatment
Experimental: Intervention group
Health education on NCDs and behavioral risk factors was delivered through motivation and observational learning session.
Behavioral: Health education
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.
Other: Carrier Guidance
Carrier opportunities and counselling




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



Secondary Outcome Measures :
  1. 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)

  2. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   14 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03975335


Locations
Layout table for location information
Bangladesh
Chi Research & Infotec Ltd.
Dhaka, Bangladesh, 1000
Sponsors and Collaborators
Chi Research & Infotec Ltd.
Directorate General of Health Services
Investigators
Layout table for investigator information
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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Chi Research & Infotec Ltd.
ClinicalTrials.gov Identifier: NCT03975335     History of Changes
Other Study ID Numbers: BSMMU/2018/5958
First Posted: June 5, 2019    Key Record Dates
Last Update Posted: June 5, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Study protocol, statistical analysis plan and informed consent form will be shared through

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Chi Research & Infotec Ltd.:
NCDs
Risk behaviors
Adolescents
Health education intervention

Additional relevant MeSH terms:
Layout table for MeSH terms
Noncommunicable Diseases
Chronic Disease
Disease Attributes
Pathologic Processes