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Individualized Motivational Print Materials to Encourage More Physical Activity

6. maj 2014 opdateret af: The Miriam Hospital

Achieving Physical Activity Guidelines Through an Enhanced Print Intervention

Individuals who are not physically active are at risk for developing heart disease, stroke, and diabetes. Using motivational print materials is one way to encourage individuals to increase their physical activity. This study will evaluate the effect that an enhanced version of an individualized, print-based motivational program has on increasing physical activity among sedentary individuals.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

256

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Rhode Island
      • Providence, Rhode Island, Forenede Stater, 02903
        • Centers for Behavioral and Preventive Medicine, The Miriam Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv 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.

Eksperimentel: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Achievement of 150 minutes per week of at least moderate intensity physical activity
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tidsramme
Moderators and mediators of the intervention (e.g., motivation and enjoyment)
Tidsramme: Measured at Months 6 and 12
Measured at Months 6 and 12
Cost-effectiveness
Tidsramme: Measured at Months 6 and 12
Measured at Months 6 and 12

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Bess H. Marcus, PhD, The Miriam Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. august 2006

Primær færdiggørelse (Faktiske)

1. april 2011

Studieafslutning (Faktiske)

1. april 2011

Datoer for studieregistrering

Først indsendt

18. august 2006

Først indsendt, der opfyldte QC-kriterier

18. august 2006

Først opslået (Skøn)

22. august 2006

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

7. maj 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. maj 2014

Sidst verificeret

1. marts 2009

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • 408
  • R01HL064342-05 (U.S. NIH-bevilling/kontrakt)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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