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Developing a Text-Message Enhanced Physical Activity Intervention for Latino Men

2019年6月21日 更新者:Dr.Bess Marcus、University of California, San Diego
The aim of this study is to build upon our tailored print intervention by developing new text-delivered intervention materials to complement our print-based physical activity (PA) intervention. In Phase 1 we will conduct 6 focus groups with Mexican and Mexican American (MA) men to determine content, frequency, and types of text messages desired, and to identify cultural themes to incorporate into existing and new materials. Themes from the focus groups and sample text messages will be presented to a confirmatory focus group panel. Phase 2 will be a 6-month pilot randomized controlled trial with Mexican and MA men (N=60) to test the text-enhanced, Spanish language, individually tailored PA intervention vs. publicly available, Spanish language health education materials, including information on PA, diet, and stress management. This will be followed by post-intervention qualitative interviews to solicit suggestions for improvements to help further refine the program. The proposed pilot will support a future R01 to establish the efficacy of this multi-media, multi-level PA intervention for Mexican and MA men.

調査の概要

状態

完了

条件

介入・治療

詳細な説明

The proposed research addresses serious public health concerns (inactivity, health disparities) in a large, rapidly growing population of Mexican American (MA) men who are markedly less physically active than men of other ethnicities and suffer from higher prevalence of conditions related to sedentary lifestyle. While this population is clearly in need of physical activity (PA) interventions, to date none have specifically targeted MA men. In fact, the majority of PA interventions for Latinos have exclusively included women and/or are designed around female preferences.The proposed study will address the needs and barriers to PA in MA men by developing text message-delivered intervention materials based on Social Cognitive Theory (SCT) to complement an individually tailored, theory-based print material PA intervention for Spanish speaking Mexican and MA men. Text messaging could be a particularly effective and appealing channel for increasing PA in this target population as it allows for participant interaction, real-time accountability, and immediate feedback, features which MA men in the demonstration trial of our print intervention specifically requested. Text-based interventions have been shown to improve a number of health behaviors, including PA. A recent review of texting interventions found that they were generally well received and effective in reducing inactivity, weight, and waist circumference,5 and a meta-analysis found a moderate effect size (g = 0.54) for using mobile devices to increase PA. However, few of these trials targeted underserved populations, and none specifically targeted Latinos. Cell phone ownership is high in Latino adults (86% vs. 84% in non-Latino Whites), and Latinos are actually the most likely to use mobile phones for text messaging, with 85% reporting regularly sending and receiving texts (compared to 79% of Whites). Thus this is a familiar, convenient channel for delivering new intervention materials. Additionally, as Latinos also face environmental barriers to PA, in the current proposal we will enhance the individually tailored psychosocial print-based materials by developing materials targeting barriers in home and work environments. This multi-media, multi-level approach has potential for broad reach at relatively low cost, which could help reduce health disparities.

研究の種類

介入

入学 (実際)

48

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

    • California
      • La Jolla、California、アメリカ、92093-0628
        • University of California San Diego

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~65年 (大人、高齢者)

健康ボランティアの受け入れ

はい

受講資格のある性別

男

説明

Inclusion Criteria:

  • Male
  • Generally healthy (If asthma, controlled high blood pressure and/or controlled type II diabetes, may be able to participate with physician consent)
  • Sedentary (Less than 60 minutes per week of moderate or vigorous physical activity)
  • Mexican and/or Mexican American (self-identified)
  • Must be able to read and write Spanish fluently
  • 18 - 65 years of age
  • Planning on living in the area for the next 6 months
  • Own a cell phone capable of sending and receiving text messages

Exclusion Criteria:

  • Body Mass Index(BMI) greater than 45
  • Not able to walk continuously for 30 minutes/limited ability to complete daily activity or ability to exercise
  • Exercise is against advice of doctor
  • Heart disease/treatment
  • Heart murmur
  • Angina/chest pain or Angina/chest pain with exertion
  • Palpitations
  • Stroke/Transient Ischemic Attacks
  • Peripheral Vascular Disease
  • Type I Diabetes
  • Uncontrolled Type II Diabetes
  • Chronic Infectious Disease - HIV, Hepatitis
  • Chronic liver disease
  • Cystic Fibrosis
  • Abnormal EKG on last EKG performed
  • Emphysema, Chronic bronchitis, Chronic Obstructive Pulmonary Disease
  • Seizure in past year
  • Surgery in past year on heart, lung, joint, orthopedic surgery
  • Surgery pending in next year on lung, joint, orthopedic surgery
  • Unusual/concerning shortness of breath
  • Asthma (may be able to participate with physician consent)
  • High blood pressure/high blood pressure medication (may be able to participate with physician consent)
  • Use of beta blockers
  • Abnormal Medical Stress Test
  • Musculoskeletal problems
  • Fainting/dizziness more than 3 times in past year OR interferes with daily activities OR causes loss of balance
  • Cancer treatment in past 3 months
  • Hospitalized for psychiatric disorder in past 3 years or suicidal

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:処理
  • 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:Text-Enhanced Physical Activity Intervention Arm
The Spanish-language PA intervention is based on Social Cognitive Theory (SCT) and Transtheoretical Model (TTM), and emphasizes behavioral strategies for increasing activity levels (i.e., goal-setting, self-monitoring, problem-solving barriers, increasing social support, rewarding oneself for meeting physical activity goals).
Participants in the Text-Enhanced Physical Activity intervention arm of the study receive a Spanish language, motivationally-tailored, print-based + text-message physical activity intervention that specifically addresses the physical activity barriers and intervention needs/preferences of Mexican and Mexican American men.
アクティブコンパレータ:Health Education Control Arm
The health education control arm will receive the publicly available NHBLI Spanish-language booklets on heart-healthy behaviors for Latinos, which include information on PA, diet, and stress management.
Participants will receive a Spanish language, print-based Wellness Contact control intervention addressing relevant health topics other than physical activity.

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
メジャーの説明
時間枠
Objectively Measured Physical Activity of at Least Moderate Intensity (MVPA) by the Actigraph GT3X+
時間枠:Baseline and 6 months
Participants will wear an Actigraph GT3X+ accelerometer, which measures movement and intensity of activity and has been validated against heart rate telemetry and total energy expenditure.
Baseline and 6 months
Self Reported Min/Week of MVPA
時間枠:baseline and 6 months
Self reported physical activity (collected via 7 day PAR)
baseline and 6 months

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。

スポンサー

協力者

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

2015年7月1日

一次修了 (実際)

2017年10月31日

研究の完了 (実際)

2017年12月31日

試験登録日

最初に提出

2015年7月29日

QC基準を満たした最初の提出物

2015年7月29日

最初の投稿 (見積もり)

2015年7月30日

学習記録の更新

投稿された最後の更新 (実際)

2019年7月16日

QC基準を満たした最後の更新が送信されました

2019年6月21日

最終確認日

2019年6月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • Activo R21
  • R21NR014911 (米国 NIH グラント/契約)

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。