NCT00788879

Brief Summary

The Tu Salud, Si Cuenta (TSSC) media campaign uses behavioral journalism, community outreach and environmental changes to promote physical activity and nutritional changes among disadvantaged Mexican-Americans living along the U.S./Mexico border. This intervention posits that increased physical activity and increased fruit and vegetable consumption with smaller portion sizes will result in a decrease in obesity prevalence and diabetes incidence in this population.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3,100

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Feb 2003

Longer than P75 for not_applicable obesity

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2003

Completed
5.8 years until next milestone

First Submitted

Initial submission to the registry

November 10, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 11, 2008

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

May 9, 2013

Status Verified

May 1, 2013

Enrollment Period

10.3 years

First QC Date

November 10, 2008

Last Update Submit

May 7, 2013

Conditions

Keywords

Behavioral JournalismMexican-AmericansObesityNutritionPhysical ActivityBorder Health

Outcome Measures

Primary Outcomes (2)

  • Physical Activity

    baseline, yr. 3, post-intervention

  • Fruit and Vegetable Intake

    baseline, yr. 3, post-intervention

Secondary Outcomes (3)

  • Waist circumference

    baseline, yr. 3, post-intervention

  • Hip circumference

    baseline, yr. 3, post-intervention

  • Confirmed Awareness: Confirmation of recognition of messages

    baseline, third year, post-intervention

Study Arms (2)

1

EXPERIMENTAL

This study arm is located in Brownsville, Texas. This community is exposed to the TSSC media messages as well as may be visited by the lay health workers and see the built environment changes

Behavioral: TSSCBehavioral: TSSC Randomized Behavioral Intervention for weight loss

2

NO INTERVENTION

The control group is located in Laredo. This community is not exposed to the TSSC messages nor does the campaign work to actively change the built environment or use lay health workers to share physical activity and nutrition information.

Interventions

TSSCBEHAVIORAL

The intervention community is exposed to the media messages of the TSSC campaign. Residents of this community also receive the lay health worker visits as well as benefit from the positive built environment changes.

1

We will enroll up to 200 weight-loss challenge participants to receive text messages on personal mobile phones throughout the challenge. Consent and enrollment in the trial will take place at registration for the weight-loss community challenge in the language of their choice. Recruited participants will be randomly assigned to a group after consenting to the study and the timing and content of text messages will vary according to group assignment (Groups A - D). Group A will receive weekly reminders for upcoming weigh-in events. Group B will receive the same weekly reminders but will also receive one-way messages every two weeks providing the participant motivational messages/topics and weight loss health tips. Group C will receive the same text messages as Group B but will also receive weekly prompts to self-monitor weight status. Group D will receive the same text messages as Group C plus daily prompts that will act as a guide for the participant to monitor behavior changes.

1

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • To be included in the evaluation survey study the participants must be living in Cameron park or Laredo TX at the time of the study, Hispanic men or women aged 20 - 75. The participants must speak Spanish.
  • To be included in the Randomized Behavioral Intervention, the participants must be participants in the weight-loss challenge and 18 years or older.

You may not qualify if:

  • Participants who will be excluded from the evaluation survey study include those who are not Hispanic, not living in Cameron Park or Laredo TX, unable to speak Spanish and are either older than 55 or younger than 20.
  • Participants excluded from the Randomized Behavioral Intervention are those younger than 18 and not participants of the weight loss challenge.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas Houston Health Science Center, Brownsville Regional Campus

Brownsville, Texas, 78521, United States

Location

Related Publications (2)

  • Reininger BM, Barroso CS, Mitchell-Bennett L, Cantu E, Fernandez ME, Gonzalez DA, Chavez M, Freeberg D, McAlister A. Process evaluation and participatory methods in an obesity-prevention media campaign for Mexican Americans. Health Promot Pract. 2010 May;11(3):347-57. doi: 10.1177/1524839908321486. Epub 2009 Jan 8.

  • Heredia NI, Lee M, Reininger BM. Exposure to a community-wide campaign is associated with physical activity and sedentary behavior among Hispanic adults on the Texas-Mexico border. BMC Public Health. 2017 Nov 16;17(1):883. doi: 10.1186/s12889-017-4893-4.

MeSH Terms

Conditions

ObesityDiabetes MellitusMotor Activity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesEndocrine System DiseasesBehavior

Study Officials

  • Belinda M Reininger, DrPH

    University of Texas Houston Health Science Center

    PRINCIPAL INVESTIGATOR
  • Kevin Hwang, MD

    University of Texas Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Health Promotion and Behavioral Sciences

Study Record Dates

First Submitted

November 10, 2008

First Posted

November 11, 2008

Study Start

February 1, 2003

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

May 9, 2013

Record last verified: 2013-05

Locations