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Temple Registry for the Investigation of African American Gastrointestinal Disease Epidemiology (TRIAGE)

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: NCT01262755
Recruitment Status : Completed
First Posted : December 17, 2010
Results First Posted : May 4, 2015
Last Update Posted : May 4, 2015
Information provided by (Responsible Party):

Study Description
Brief Summary:
DESCRIPTION: Minimal data exists on the prevalence of gastroesophageal reflux disease in minority populations. Specific objectives of this K24 research project are to: (1) Provide an estimate of the prevalence of gastroesophageal reflux disease in an urban, African American population; (2) Determine whether specific risk factors including diet, tobacco use, physical activity, and psychosocial stress are important in the targeted population. We will also measure height, weight, and waist/hip circumference to determine the impact of central obesity on reflux. PUBLIC HEALTH RELEVANCE: This research will help doctors to understand the frequency and risks for esophageal reflux disease (heartburn) in African Americans.

Condition or disease Intervention/treatment
Gastroesophageal Reflux Disease Functional Bowel Disorders Behavioral: Structured Interview

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Study Design

Study Type : Observational
Actual Enrollment : 450 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Temple Registry for the Investigation of African American Gastrointestinal Disease Epidemiology
Study Start Date : April 2010
Primary Completion Date : January 2015
Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
African Americans
Consists of 450 African Americans living in the zip code surrounding Temple Hospital between the ages of 18 and 80.
Behavioral: Structured Interview
Subjects underwent a structured interview using a laptop computer and answered over 200 standardized questions. All patient had their height, weight, and waist circumference measured.

Outcome Measures

Primary Outcome Measures :
  1. Epidemiologic Factors Associated With Prevalent Reflux Disease. [ Time Frame: Two years ]
    Patients will complete a series of standardized questionnaires to determine the prevalence of reflux disease and risk factors for its development. We will query diet, depression, drug, tobacco, and alcohol use as well as a variety of other factors. We will study 450 African Americans living in North Philadelphia.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
All adult individuals (age 18-80)residing in the 19140 zip code area will be eligible for participation. We will interview 750 African American residents and 250 self-described Caucasian residents.

Inclusion Criteria:

  • age over 18
  • self-described African American or Caucasian
  • lived in zip code for > 3 years

Exclusion Criteria:

  • newly arrived to zip code
  • unable to provide proof of address
  • unwilling to come to temple to complete interview
Contacts and Locations

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): NCT01262755

United States, Pennsylvania
Temple University Hospital
Philadelphia, Pennsylvania, United States, 19140
Sponsors and Collaborators
Temple University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Frank K Friedenberg, MD Temple University
More Information

Additional Information:
Responsible Party: Frank K. Friedenberg, Professor of Medicine, Temple University
ClinicalTrials.gov Identifier: NCT01262755     History of Changes
Other Study ID Numbers: K24DK083268 ( U.S. NIH Grant/Contract )
First Posted: December 17, 2010    Key Record Dates
Results First Posted: May 4, 2015
Last Update Posted: May 4, 2015
Last Verified: April 2015

Keywords provided by Frank K. Friedenberg, Temple University:

Additional relevant MeSH terms:
Gastroesophageal Reflux
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases