Non-communicable Disease Risk Factors Clinical Trial
Official title:
An Intervention Program to Reduce NCD Related Behavioral Risk Factor Among Adolescents in Institutional Settings of Bangladesh
| Verified date | June 2019 |
| Source | Chi Research & Infotec Ltd. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 823 |
| Est. completion date | August 20, 2018 |
| Est. primary completion date | August 20, 2018 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 14 Years to 18 Years |
| Eligibility |
Inclusion Criteria: • Practicing at least two risk behaviors from three- unhealthy diet, physical inactivity and smoking Exclusion Criteria: • Physically disabled or having limited movement |
| Country | Name | City | State |
|---|---|---|---|
| Bangladesh | Chi Research & Infotec Ltd. | Dhaka |
| Lead Sponsor | Collaborator |
|---|---|
| Chi Research & Infotec Ltd. | Directorate General of Health Services |
Bangladesh,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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. |
Three months | |
| Secondary | 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) | Three months | |
| Secondary | 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. | Three months |