NCT00903318

Brief Summary

Objective 1: To assess environmental exposure to chemicals/toxins, including phthalates, among rural and urban Mexican American men and women (n=300), aged 18 to 40, in urban Baytown, TX and rural Rio Grande Valley (Hidalgo County) communities along the Texas-Mexico border region via survey. Objective 2: To determine generational sex ratio trends in urban Baytown, TX and along the rural Rio Grande Valley (Hidalgo County) utilizing vital statistics data from the Texas Department of Health and the Center for Health Statistics. Objective 3: To measure urinary phthalate levels and self-reported phthalate exposure in Mexican American men and women from urban Baytown, Texas and rural communities along the lower Rio Grande Valley (Hidalgo County) on theTexas-Mexico border. To conduct an optional procedure, chromosomal sex determination, among a subgroup of 50 persons (13 men + 12 women in each community) from participants who complete the survey in Objective 1.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2009

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 15, 2009

Completed
Same day until next milestone

Study Start

First participant enrolled

May 15, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 18, 2009

Completed
7.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 9, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 9, 2017

Completed
Last Updated

February 13, 2017

Status Verified

February 1, 2017

Enrollment Period

7.7 years

First QC Date

May 15, 2009

Last Update Submit

February 10, 2017

Conditions

Keywords

EndocrineEnvironmental ChemicalsMale:Female Birth RatioPhthalate ExposureGenerational sex ratio trendsMexican AmericanBaytownRio Grande ValleyHidalgo CountyTexas

Outcome Measures

Primary Outcomes (1)

  • Prevalence of exposure to chemical/toxins (Survey Responses)

    3 Years

Study Arms (1)

Mexican American Men and Women

Rural and urban Mexican American men and women , aged 18 to 40, in urban Baytown, TX and rural Rio Grande Valley (Hidalgo County) communities along the Texas-Mexico border

Behavioral: Questionnaire

Interventions

QuestionnaireBEHAVIORAL

Questionnaire about family's characteristics taking about 30-35 minutes to complete.

Also known as: Survey
Mexican American Men and Women

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Men and Women of Mexican American origin ages 18 to 40 years, residing in Baytown or the lower Rio Grande Valley in Hidalgo County, Texas for at least 45 years.

You may qualify if:

  • Men and Women of Mexican American origin ages 18 to 40 years
  • Residing in Baytown or the lower Rio Grande Valley in Hidalgo County, Texas
  • Who have signed the informed consent
  • Individuals will have had to reside in the study area for at least 5 years
  • Pregnant women are eligible for the study.

You may not qualify if:

  • \) None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Goose Creek Consolidated Independent School District

Baytown, Texas, 77521, United States

Location

Texas Southern University

Houston, Texas, 77004, United States

Location

LaJoya Independent School District

La Joya, Texas, 78560, United States

Location

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Urine sample.

MeSH Terms

Conditions

Endocrine System Diseases

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Richard A. Hajek, PHD, MS, BA

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2009

First Posted

May 18, 2009

Study Start

May 15, 2009

Primary Completion

February 9, 2017

Study Completion

February 9, 2017

Last Updated

February 13, 2017

Record last verified: 2017-02

Locations