NCT03316495

Brief Summary

Tobacco smoke is one of the most preventable cause of mortality and morbidity worlwide, this study is conducted to compare the knowledge of the health effects of smoking among undergraduates exposed and those not exposed to educational pamphlet. This is designed as a randomized clinical trial among 390 undergraduate in University of Benin Edo State Nigeria. Data collection tool was an interviewer-administered questionnaire. Data obtained would be subjected to regression statistics using IBM SPSS version 21.0. The expected outcome will be a veritable tool in tobacco cessation model.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2017

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2017

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 3, 2017

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

October 17, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 20, 2017

Completed
Last Updated

October 20, 2017

Status Verified

October 1, 2017

Enrollment Period

7 months

First QC Date

October 17, 2017

Last Update Submit

October 17, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • KNOWLEDGE OF HEALTH EFFECT OF SMOKING

    QUESTIONNAIRE

    7 MONTHS

Study Arms (2)

without pamphlet

NO INTERVENTION

NOT EXPOSED TO PAMPHLETS

with pamphlet

EXPERIMENTAL

EXPOSED TO PAMPHLETS

Behavioral: PAMPHLET

Interventions

PAMPHLETBEHAVIORAL

EXPOSURE TO PAMPHLETS

with pamphlet

Eligibility Criteria

Age16 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • \- HEALTHY

You may not qualify if:

  • NOT CONSENTING

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clement Chinedu Azodo

Benin City, Edo, 300001, Nigeria

Location

MeSH Terms

Conditions

Tobacco Use Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Department

Study Record Dates

First Submitted

October 17, 2017

First Posted

October 20, 2017

Study Start

March 1, 2017

Primary Completion

September 30, 2017

Study Completion

October 3, 2017

Last Updated

October 20, 2017

Record last verified: 2017-10

Locations