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Tu Salud Si Cuenta Media Campaign (TSSC)

7 de maio de 2013 atualizado por: Belinda Reininger, The University of Texas Health Science Center, Houston

Evaluation of a Media Campaign: Tu Salud Si Cuenta

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.

Visão geral do estudo

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Real)

3100

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

    • Texas
      • Brownsville, Texas, Estados Unidos, 78521
        • University of Texas Houston Health Science Center, Brownsville Regional Campus

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 75 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Prevenção
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: 1
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
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.

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.

Sem intervenção: 2
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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Prazo
Physical Activity
Prazo: baseline, yr. 3, post-intervention
baseline, yr. 3, post-intervention
Fruit and Vegetable Intake
Prazo: baseline, yr. 3, post-intervention
baseline, yr. 3, post-intervention

Medidas de resultados secundários

Medida de resultado
Prazo
Waist circumference
Prazo: baseline, yr. 3, post-intervention
baseline, yr. 3, post-intervention
Hip circumference
Prazo: baseline, yr. 3, post-intervention
baseline, yr. 3, post-intervention
Confirmed Awareness: Confirmation of recognition of messages
Prazo: baseline, third year, post-intervention
baseline, third year, post-intervention

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Investigadores

  • Investigador principal: Belinda M Reininger, DrPH, University of Texas Houston Health Science Center
  • Investigador principal: Kevin Hwang, MD, University of Texas Medical School

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de fevereiro de 2003

Conclusão Primária (Real)

1 de maio de 2013

Conclusão do estudo (Real)

1 de maio de 2013

Datas de inscrição no estudo

Enviado pela primeira vez

10 de novembro de 2008

Enviado pela primeira vez que atendeu aos critérios de CQ

10 de novembro de 2008

Primeira postagem (Estimativa)

11 de novembro de 2008

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

9 de maio de 2013

Última atualização enviada que atendeu aos critérios de controle de qualidade

7 de maio de 2013

Última verificação

1 de maio de 2013

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • HSC-SPH-05-0488
  • NIH NCMHD P20 MD000170-06

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

produto fabricado e exportado dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

Ensaios clínicos em TSSC

3
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