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Tu Salud Si Cuenta Media Campaign (TSSC)

2013年5月7日 更新者: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.

調査の概要

詳細な説明

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.

研究の種類

介入

入学 (実際)

3100

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • Texas
      • Brownsville、Texas、アメリカ、78521
        • University of Texas Houston Health Science Center, Brownsville Regional Campus

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年~75年 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:防止
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
実験的: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.

介入なし: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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
時間枠
Physical Activity
時間枠:baseline, yr. 3, post-intervention
baseline, yr. 3, post-intervention
Fruit and Vegetable Intake
時間枠:baseline, yr. 3, post-intervention
baseline, yr. 3, post-intervention

二次結果の測定

結果測定
時間枠
Waist circumference
時間枠:baseline, yr. 3, post-intervention
baseline, yr. 3, post-intervention
Hip circumference
時間枠:baseline, yr. 3, post-intervention
baseline, yr. 3, post-intervention
Confirmed Awareness: Confirmation of recognition of messages
時間枠:baseline, third year, post-intervention
baseline, third year, post-intervention

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

捜査官

  • 主任研究者:Belinda M Reininger, DrPH、University of Texas Houston Health Science Center
  • 主任研究者:Kevin Hwang, MD、University of Texas Medical School

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2003年2月1日

一次修了 (実際)

2013年5月1日

研究の完了 (実際)

2013年5月1日

試験登録日

最初に提出

2008年11月10日

QC基準を満たした最初の提出物

2008年11月10日

最初の投稿 (見積もり)

2008年11月11日

学習記録の更新

投稿された最後の更新 (見積もり)

2013年5月9日

QC基準を満たした最後の更新が送信されました

2013年5月7日

最終確認日

2013年5月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

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

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

米国で製造され、米国から輸出された製品。

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

TSSCの臨床試験

3
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