- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00367029
Individualized Motivational Print Materials to Encourage More Physical Activity
Achieving Physical Activity Guidelines Through an Enhanced Print Intervention
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 3
Contatti e Sedi
Luoghi di studio
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Rhode Island
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Providence, Rhode Island, Stati Uniti, 02903
- Centers for Behavioral and Preventive Medicine, The Miriam Hospital
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore attivo: 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. |
|
Sperimentale: 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. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Achievement of 150 minutes per week of at least moderate intensity physical activity
Lasso di tempo: Measured by the 7-day Physical Activity Recall test at Months 6 and 12
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Measured by the 7-day Physical Activity Recall test at Months 6 and 12
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Moderators and mediators of the intervention (e.g., motivation and enjoyment)
Lasso di tempo: Measured at Months 6 and 12
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Measured at Months 6 and 12
|
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Cost-effectiveness
Lasso di tempo: Measured at Months 6 and 12
|
Measured at Months 6 and 12
|
Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Bess H. Marcus, PhD, The Miriam Hospital
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- 408
- R01HL064342-05 (Sovvenzione/contratto NIH degli Stati Uniti)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .