- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02615652
The Impact of Lifestyle on Mental Health Among Young Men in the Gilgel Gibe Field Research Center, Ethiopia: Pilot Study
May 10, 2017 updated by: Michael Odenwald, University of Konstanz
Researchers of the three collaborating universities implement a pilot observational study in "Gilgel Gibe Field Research Center", a health and demographic surveillance system run by the Jimma University, Ethiopia.
In this setting, the investigators plan to study risk factors in young men for the development of common mental disorders and psychotic symptoms and the stability of distinct symptoms of mental disorders in the community.
The investigators will explore in particular the impact of lifestyle on mental health in young men, including the traditional habit of chewing khat leaves, which contain amphetamine-like cathinone.
Furthermore, the investigators want to demonstrate the reliability and validity of assessments performed by trained local interviewers.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
865
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 30 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Sampling Method
Probability Sample
Study Population
Young adult male inhabitants of the Gilgel Gibe field research center.
Description
Inclusion Criteria:
- Male, Age 18 - 30, permanent residents in Gilgel Gibe
Exclusion Criteria:
- Prior existing severe mental health problems
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Ecologic or Community
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
psychotic symptoms
Time Frame: through study completion, within 2 months
|
presence of self-reported psychotic symptoms during the month before interview
|
through study completion, within 2 months
|
symptoms of Common Mental Disorders
Time Frame: through study completion, within 2 months
|
presence of self-reported CMD symptoms during the month before interview
|
through study completion, within 2 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
amount of khat use
Time Frame: through study completion, within 2 months
|
self-reported amount of khat standard units consumed last week
|
through study completion, within 2 months
|
amount of alcohol use
Time Frame: through study completion, within 2 months
|
self-reported amount of alcohol standard units consumed last week
|
through study completion, within 2 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2015
Primary Completion (Actual)
January 1, 2016
Study Completion (Actual)
July 1, 2016
Study Registration Dates
First Submitted
November 22, 2015
First Submitted That Met QC Criteria
November 24, 2015
First Posted (Estimate)
November 26, 2015
Study Record Updates
Last Update Posted (Actual)
May 11, 2017
Last Update Submitted That Met QC Criteria
May 10, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- University of Konstanz
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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