- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT02512419
Developing a Text-Message Enhanced Physical Activity Intervention for Latino Men
21. Juni 2019 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
48
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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California
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La Jolla, California, Vereinigte Staaten, 92093-0628
- University of California San Diego
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre bis 65 Jahre (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Ja
Studienberechtigte Geschlechter
Männlich
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Experimental: 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).
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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.
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Aktiver Komparator: 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.
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Participants will receive a Spanish language, print-based Wellness Contact control intervention addressing relevant health topics other than physical activity.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Objectively Measured Physical Activity of at Least Moderate Intensity (MVPA) by the Actigraph GT3X+
Zeitfenster: Baseline and 6 months
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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.
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Baseline and 6 months
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Self Reported Min/Week of MVPA
Zeitfenster: baseline and 6 months
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Self reported physical activity (collected via 7 day PAR)
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baseline and 6 months
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Mitarbeiter
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. Juli 2015
Primärer Abschluss (Tatsächlich)
31. Oktober 2017
Studienabschluss (Tatsächlich)
31. Dezember 2017
Studienanmeldedaten
Zuerst eingereicht
29. Juli 2015
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
29. Juli 2015
Zuerst gepostet (Schätzen)
30. Juli 2015
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
16. Juli 2019
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
21. Juni 2019
Zuletzt verifiziert
1. Juni 2019
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- Activo R21
- R21NR014911 (US NIH Stipendium/Vertrag)
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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