Evaluation of a Media Campaign: Tu Salud Si Cuenta
Tu Salud Si Cuenta Media Campaign
Sponsors
Source
The University of Texas Health Science Center, Houston
Oversight Info
Has Dmc
No
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.
Detailed Description
The TSSC campaign relies on behavioral journalism which includes the use of Spanish language,
attractive and influential role models to illustrate healthy physical activity and
nutritional habits through television, radio, and print media, to convey healthy physical
activity and nutritional messages to the target population. This intervention method will be
coupled with community outreach and environmental changes in the host community to further
promote these changes. Community outreach includes the use of local, lay community workers to
provide information and health screenings. Environmental changes focus on creating a positive
built environment that promotes physical activity through well-lit streets, walking trails
and safe recreational areas and healthy nutritional behaviors through increased access to
markets and centers where affordable produce can be purchased and nutritional knowledge on
healthy foods preparation and use can be disseminated.
As part of this intervention, a promoter-led community weight-loss challenge will be
comprised of participants from the City of Brownsville's sixteen week weight-loss challenge.
The location and site of the weigh-ins for this challenge occur at City Parks and Recreation
facility on designated dates. Community members who select to participate in the city's
weight loss challenge will be exposed to the Tu Salud Si Cuenta campaign. These individuals
will have the same access to promoter-led exercise classes and nutrition education sessions,
similar to CCHC participants. Recruited participants will also have the same access to
information provided by promoters about health, physical activity and healthful food choices
using motivational interviewing strategies. Participants of the weight-loss challenge are
asked to weigh-in at least two times during the challenge and have their height, blood
pressure and hip and waist circumference assessed.
We are proposing to evaluate the efficacy of this weight loss challenge more stringently and
answer two important questions. The firs is what timing and types of support via text
messages is appropriate for supporting weight loss in a community based weight loss
challenge? The second question is what is the long term weight loss maintenance of
participants in the 16 week weight loss challenge?
To answer the first question we will recruit and enroll Individuals who participate in the
weight-loss challenge in a randomized behavioral intervention trial examining exposure to
text messages and weight loss outcomes. Prior research has shown that making a change in
behavior and weight loss can be dependent upon the type of messages provided to an individual
(Rothman AJ, Salovey P, Antone C, et al, 1993; Patrick K, Raab F, Adams MA, 2009). We will
test whether different content delivered via text messages impacts weight loss outcomes.
For this study, we will enroll up to 200 weight-loss challenge participants to receive text
messages on their personal mobile phones throughout the 16 week 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. The final group, 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 his or her behavior changes.
Participants will be asked to complete a short questionnaire about fruit and vegetable
consumption, physical activity and social support for weight loss at the initial and final
weigh in. (See attachment) We will also conduct a brief qualitative interview with 10 people
per group about their opinions regarding the texting content and frequency. Finally, they
will also consent for the research team to access their weight loss measures at initial and
final weigh in and use in the research project to assess weight status changes. For those
participants who do not attend final weigh in, the research team will contact the participant
to obtain a final weight. At the time of enrollment into the behavioral intervention trial,
participants will receive a $5 incentive. They will also receive an additional $10 incentive
at the final weigh-in with their completed measures.
To answer the second research question of what is the long term weight loss maintenance of
participants in the 16 week weight loss challenge we are proposing a follow-up feasibility
study. We will enroll and consent Biggest Loser Challenge participants in a study that will
follow them beyond the 16 week challenge one time at three months. At the registration of the
weight-loss challenge participants will be consented in the language of their choice.
This study will enroll up to 150 consenting participants. Participants will have their
height, weight, blood pressure and hip and waist circumference measures at initial, final
weigh-in and 3 months post using the same protocols as all other Biggest Loser Challenge
Participants. Weight will be taken using a calibrated Tanita scale and hip and waist
circumference will be measured with a tape measure following protocols used in our CCHC
(described below). Trained individual will take all measurements. A special number will be
used to identify the participant in the study and only the investigator will know their name.
These study participants however will also complete a short questionnaire about fruit and
vegetable consumption, physical activity and social support for weight loss. (see attachment-
this is the same instrument being used in the behavioral intervention trial examining text
messaging)
For Biggest Loser Challenge participants who do not complete the final weigh-in measure but
who have enrolled in this study, staff will contact the participants and schedule a time and
location to obtain the final weigh in measures. The measures will need to be obtained within
three weeks of the scheduled final weigh in challenge date. For the three month follow-up
contact again we will contact the participant and schedule a time and location to obtain
follow-up measures. Following all measurements (during the challenge and follow-up period),
participants will have the opportunity to discuss their results with a community health
worker trained to discuss these issues.
Individuals who complete the additional measures beyond the challenge period will receive
incentives for their time associated with participating in the research study. Participants
will receive an item valued at $5.00 for completing the three month post measurements.
Overall Status
Completed
Start Date
2003-02-01
Completion Date
2013-05-01
Primary Completion Date
2013-05-01
Phase
N/A
Study Type
Interventional
Primary Outcome
Measure |
Time Frame |
Physical Activity |
baseline, yr. 3, post-intervention |
Fruit and Vegetable Intake |
baseline, yr. 3, post-intervention |
Secondary Outcome
Measure |
Time Frame |
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 |
Enrollment
3100
Conditions
Intervention
Intervention Type
Behavioral
Intervention Name
Description
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.
Arm Group Label
1
Intervention Type
Behavioral
Intervention Name
Description
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.
Arm Group Label
1
Eligibility
Criteria
Inclusion Criteria:
- 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 observational study of physical activity the participants must
be visiting the observational study site (park, exercise facility, walking trail) at
the time of observation. No other criteria for inclusion exists for this study.
- To be included in the Randomized Behavioral Intervention, the participants must be
participants in the weight-loss challenge and 18 years or older.
Exclusion Criteria:
- 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.
Gender
All
Minimum Age
18 Years
Maximum Age
75 Years
Healthy Volunteers
Accepts Healthy Volunteers
Overall Official
Last Name |
Role |
Affiliation |
Belinda M Reininger, DrPH |
Principal Investigator |
University of Texas Houston Health Science Center |
Kevin Hwang, MD |
Principal Investigator |
University of Texas Medical School |
Location
Facility |
University of Texas Houston Health Science Center, Brownsville Regional Campus Brownsville Texas 78521 United States |
Location Countries
Country
United States
Verification Date
2013-05-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Principal Investigator
Investigator Affiliation
The University of Texas Health Science Center, Houston
Investigator Full Name
Belinda Reininger
Investigator Title
Associate Professor, Health Promotion and Behavioral Sciences
Keywords
Has Expanded Access
No
Condition Browse
Secondary Id
NIH NCMHD P20 MD000170-06
Number Of Arms
2
Arm Group
Arm Group Label
1
Arm Group Type
Experimental
Description
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
Arm Group Label
2
Arm Group Type
No Intervention
Description
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.
Results Reference
Citation
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.
PMID
19131541
Firstreceived Results Date
N/A
Acronym
TSSC
Firstreceived Results Disposition Date
N/A
Study Design Info
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
None (Open Label)
Study First Submitted
November 10, 2008
Study First Submitted Qc
November 10, 2008
Study First Posted
November 11, 2008
Last Update Submitted
May 7, 2013
Last Update Submitted Qc
May 7, 2013
Last Update Posted
May 9, 2013
ClinicalTrials.gov processed this data on December 12, 2019
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.