- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00367029
Individualized Motivational Print Materials to Encourage More Physical Activity
Achieving Physical Activity Guidelines Through an Enhanced Print Intervention
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Currently, only 32% of adults in the United States participate in regular physical activity. Several healthcare organizations, including the Centers for Disease Control and Prevention, the National Institutes of Health, and the American Heart Association recommend that adults engage in a minimum of 2 ½ hours of physical activity each week. In a previous study, individuals who received motivational print materials in the mail increased their weekly physical activity more than individuals who received no motivational materials or who received motivational support over the telephone. However, about half of those who were mailed the print materials still did not reach the recommended goal of 2 ½ hours of physical activity per week. The purpose of this study is to compare the effectiveness of an enhanced version of an individualized, print-based motivational program versus a previously tested print-based motivational program at increasing physical activity levels in sedentary individuals.
This study will enroll healthy, sedentary individuals. Participants will be randomly assigned to either a print-based, individually tailored motivational program or an enhanced version of the same program. All participants will attend a baseline study visit, which will include body measurements, physical activity assessments, and health and psychological questionnaires. A select group of participants will also take part in an exercise test. Participants will then document their monthly physical activity. Study researchers will use this information, as well as the completed questionnaires, to develop individualized reports, manuals, and tip sheets that include feedback and strategies for increasing physical activity for each participant. Materials will be mailed to participants 14 times throughout the year. Participants in the enhanced intervention will receive additional materials that focus on increasing social support, self regulation, and outcome expectations, as well as materials on how to effectively monitor physical activity levels. They will also attend one study visit to assess their goals with the research staff. At Months 6 and 12, baseline evaluations will be repeated and all participants will be interviewed to assess physical activity levels.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 3
Kontakte und Standorte
Studienorte
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Rhode Island
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Providence, Rhode Island, Vereinigte Staaten, 02903
- Centers for Behavioral and Preventive Medicine, The Miriam Hospital
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- In good general health
- Sedentary
- Able to speak and read English
- Planning to live in the area for the duration of the study
Exclusion Criteria:
- Currently participates in 91 or more minutes of moderate or vigorous physical activity per week
- Heart disease
- Cerebrovascular disease
- Peripheral vascular disease
- Chronic obstructive pulmonary disease
- Diabetes
- High blood pressure
- History of gastric bypass surgery
- Psychoses
- Any serious medical problem that would make exercise unsafe or unwise
- Prior participation in a hospital-based or medically supervised weight loss program
- Excessive alcohol consumption
- Pregnant or plans to become pregnant
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Aktiver Komparator: 1
Print-based, individually tailored motivational program
|
Study researchers will develop individualized reports, manuals, and tip sheets that include feedback and strategies for increasing physical activity for each participant. Materials will be mailed to participants 14 times throughout the year. Participants in the enhanced intervention will receive additional materials that focus on increasing social support, self regulation, and outcome expectations, as well as materials on how to effectively monitor physical activity levels. They will also attend one study visit to assess their goals with the research staff. |
|
Experimental: 2
Enhanced version of the print-based, individually tailored motivational program
|
Study researchers will develop individualized reports, manuals, and tip sheets that include feedback and strategies for increasing physical activity for each participant. Materials will be mailed to participants 14 times throughout the year. Participants in the enhanced intervention will receive additional materials that focus on increasing social support, self regulation, and outcome expectations, as well as materials on how to effectively monitor physical activity levels. They will also attend one study visit to assess their goals with the research staff. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
Achievement of 150 minutes per week of at least moderate intensity physical activity
Zeitfenster: Measured by the 7-day Physical Activity Recall test at Months 6 and 12
|
Measured by the 7-day Physical Activity Recall test at Months 6 and 12
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
Moderators and mediators of the intervention (e.g., motivation and enjoyment)
Zeitfenster: Measured at Months 6 and 12
|
Measured at Months 6 and 12
|
|
Cost-effectiveness
Zeitfenster: Measured at Months 6 and 12
|
Measured at Months 6 and 12
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Bess H. Marcus, PhD, The Miriam Hospital
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- 408
- R01HL064342-05 (US NIH Stipendium/Vertrag)
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