NCT00870207

Brief Summary

Building on existing intervention strategies of the Tu Salud Si Cuenta media campaign, this proposed worksite pilot study will be testing a new feature by designing worksite promotion intervention strategies. The purpose of this study is to test the feasibility of a worksite-based physical activity and healthful food choice. The intervention will be among two worksites in the Lower Rio Grande Valley who employ primarily Mexican-American personnel.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Nov 2010

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

2 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

March 26, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 27, 2009

Completed
1.6 years until next milestone

Study Start

First participant enrolled

November 1, 2010

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

May 3, 2011

Status Verified

April 1, 2011

Enrollment Period

3 months

First QC Date

March 26, 2009

Last Update Submit

April 29, 2011

Conditions

ObesityPhysical ActivityDietStress

Keywords

Feasibility of implementing TSSC in worksite environment

Outcome Measures

Primary Outcomes (1)

  • The primary purpose of this pilot study is to test the feasibility of implementing Tu Salud Si Cuenta in a worksite environment.

    One year

Study Arms (2)

Immediate Intervention Group

OTHER

The immediate intervention group will receive the TSSC pilot worksite intervention in the initial 12 week period from the pre-test/enrollment visit.

Behavioral: Tu Salud Si Cuenta Worksite Intervention

Delayed Intervention Group

OTHER

The delayed intervention group will receive the TSSC pilot worksite intervention beginning in month 6 of the study (6 months from the enrollment/pre-test visit).

Behavioral: Tu Salud Si Cuenta Worksite Intervention

Interventions

Tu Salud Si Cuenta Worksite InterventionBEHAVIORAL

The intervention will consist of providing TSSC newsletters to employees of the worksite. Additionally, informational sessions about physical activity and healthful food choice (consistent with the TSSC messages) during work hours will be implemented. Social support groups for the behavior changes will be established thru colleague networks. Individualized behavior change plans will be designed for enrolled participants. Additionally, environmental changes including a well equipped exercise facility on site and access to healthful foods in vending machines and work groups providing fruit and vegetable access in kitchen area will be implemented.

Delayed Intervention GroupImmediate Intervention Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women who are full- or part-time employees of either State Department of Public health Region 11 Harlingen Office or City of Brownsville.
  • Persons of any racial/ethnic group aged between 18-65 years.
  • Persons who are comfortable communicating in English (speaking, reading, and writing).
  • Persons who are cleared by a physician for participation in the study.

You may not qualify if:

  • Persons older than 65 years or younger than 18 years.
  • Persons not currently employed with either of the two worksite partners.
  • Persons who are not medically cleared by personal physician.
  • Persons who are not comfortable communicating in English (speaking, reading, and writing).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

City of Brownsville

Brownsville, Texas, 78520, United States

Location

State Department of Public Health Region 11 Harlingen Office

Harlingen, Texas, 78550, United States

Location

Related Publications (10)

  • Wang Y, Beydoun MA. The obesity epidemic in the United States--gender, age, socioeconomic, racial/ethnic, and geographic characteristics: a systematic review and meta-regression analysis. Epidemiol Rev. 2007;29:6-28. doi: 10.1093/epirev/mxm007. Epub 2007 May 17.

    PMID: 17510091BACKGROUND

  • Wang Y, Zhang Q. Are American children and adolescents of low socioeconomic status at increased risk of obesity? Changes in the association between overweight and family income between 1971 and 2002. Am J Clin Nutr. 2006 Oct;84(4):707-16. doi: 10.1093/ajcn/84.4.707.

    PMID: 17023695BACKGROUND

  • Wang Y, Beydoun MA, Liang L, Caballero B, Kumanyika SK. Will all Americans become overweight or obese? estimating the progression and cost of the US obesity epidemic. Obesity (Silver Spring). 2008 Oct;16(10):2323-30. doi: 10.1038/oby.2008.351. Epub 2008 Jul 24.

    PMID: 18719634BACKGROUND

  • Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.

    PMID: 12900694BACKGROUND

  • Fava JL, Ruggiero L, Grimley DM. The development and structural confirmation of the Rhode Island Stress and Coping Inventory. J Behav Med. 1998 Dec;21(6):601-11. doi: 10.1023/a:1018752813896.

    PMID: 9891257BACKGROUND

  • Finley, R. (2008). SurveyMonkey.com [Computer software]. Portland, OR: SurveyMonkey.com.

    BACKGROUND

  • Haskell WL, Lee IM, Pate RR, Powell KE, Blair SN, Franklin BA, Macera CA, Heath GW, Thompson PD, Bauman A. Physical activity and public health: updated recommendation for adults from the American College of Sports Medicine and the American Heart Association. Med Sci Sports Exerc. 2007 Aug;39(8):1423-34. doi: 10.1249/mss.0b013e3180616b27.

    PMID: 17762377BACKGROUND

  • Hoelscher DM, Day RS, Kelder SH, Ward JL. Reproducibility and validity of the secondary level School-Based Nutrition Monitoring student questionnaire. J Am Diet Assoc. 2003 Feb;103(2):186-94. doi: 10.1053/jada.2003.50031.

    PMID: 12589324BACKGROUND

  • Wolfinger, R. & O'Connell, M. (1993). Generalized linear mixed effects models: A pseudo-likelihood approach. Journal of Statistical Computation and Simulation, 48, 233-243.

    BACKGROUND

  • Zeger SL, Liang KY. Longitudinal data analysis for discrete and continuous outcomes. Biometrics. 1986 Mar;42(1):121-30.

    PMID: 3719049BACKGROUND

MeSH Terms

Conditions

ObesityMotor Activity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Belinda Reininger, DrPH

    University of Texas Health Science Center at Houston School of Public Health - Brownsville Regional Campus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 26, 2009

First Posted

March 27, 2009

Study Start

November 1, 2010

Primary Completion

February 1, 2011

Study Completion

April 1, 2011

Last Updated

May 3, 2011

Record last verified: 2011-04

Locations

US(2)