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Planning the Next Steps: Using an Implementation Intention Approach to Increase Daily Walking

19. juli 2018 opdateret af: Brandeis University
The study goal is to design an intervention utilizing implementation intentions to help participants prospectively plan and visualize ways to increase activity for the next day among working adults who do not currently exercise or use an activity monitor. Investigators will assess the level of and changes in physical activity, and how this relates to various individual factors that are related to exercise and health, including self-efficacy, control beliefs, and cognition.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The 5-week study consists of a 1-week baseline, where participants are asked to wear a Fitbit to document the number of steps taken that day to establish an objective measurement of steps before the intervention began. In the intervention condition, after the baseline week, during weeks 2 to 5, this condition is prompted with an email each evening for four weeks to review their schedules for the following day and identify time slots where they could add activity. They are given instructions for providing a detailed calendar of appointments and open slots for the next day using a simple daily planner. The planning implementation intention manipulation involves recording specific information about when, where, and how they will add steps to their day. They are provided with maps near their home and work with specific information about distances, estimated time to walk between different points, and number of steps for specific routes to help them in planning for specific routes.The control condition is matched for how much contact they have with the research staff (called and emailed the same amount of times) and also wear the Fitbit daily. The only difference from the intervention group is that they do not get the daily planning instructions or maps for the implementation intention strategy treatment. All activity data from the Fitbit was deidentified and aggregated with an online platform called Fitabase.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

63

Fase

  • Ikke anvendelig

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

35 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Currently working full time
  • Not engaged in regular exercise
  • 35 years of age or older

Exclusion Criteria:

  • Not healthy enough to engage in a walking intervention

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

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

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Control group
Participants will wear a Fitbit Zip to record their daily activity data, which will be deidentified and aggregated with an online platform called Fitabase. Participants in the control group will be matched with the intervention group for how much contact they have with the researcher.
Adfærdsmæssigt: Control Group
Participants will wear a Fitbit Zip for 5 weeks to record their daily activity data. The first week of the study will provide a baseline measurement of activity. After this week, participants in this condition will begin receiving daily emails asking them to report their step count in a questionnaire. Participants in the control group will be matched with the intervention group for how much contact they have with the researcher.
Eksperimentel: Implementation Intention Condition
Participants will wear a Fitbit Zip to record their daily activity data, which will be deidentified and aggregated with an online platform called Fitabase. Participants in this arm will receive all components of the intervention: scheduling, maps, and activity goals.
Adfærdsmæssigt: Implementation Intention Condition
Participants will wear a Fitbit Zip for 5 weeks to record their daily activity data. The first week of the study will provide a baseline measurement of activity. After this week, participants will be asked to increase their steps incrementally by 2,000 steps each week for the subsequent four weeks. To help achieve their step goals, they will receive maps of different routes near their home and/or work of varying distances and step counts. They will be asked to review their schedule for the next day and identify times when they could add steps into their schedules, and to record their daily step data in the daily questionnaire.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Steps
Tidsramme: Week 1 & Week 5
Weekly average of daily step counts with Fitbit (averaged across 7 days at Week 1 and averaged across 7 days at Week 5).
Week 1 & Week 5
Activity Intensity
Tidsramme: Week 1 & Week 5
Weekly average of daily time spent in moderate to vigorous intensity activity (averaged across 7 days at Week 1 and averaged across 7 days at Week 5).
Week 1 & Week 5

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Cognitive Composite Score
Tidsramme: Baseline (Pre-Test) and Week 5 (Post-Test )
Z-score composite on the Brief Test of Adult Cognition by Telephone (BTACT). Individual tests scores were first standardized to z-scores. The z-score composite was calculated by averaging the z-scores of the 5 tests: word list immediate, word list delayed, backwards counting, digits backwards, and category fluency. Post-test z-scores were standardized based on the mean and s.d. of the pretest scores. A higher z-score is indicative of better cognitive functioning.
Baseline (Pre-Test) and Week 5 (Post-Test )
Exercise Control Beliefs
Tidsramme: Baseline (Pre-Test) and Week 5 (Post-Test )
Degree of perceived control over Exercise. Range from 1 (Strongly agree) to 5 (strongly agree). Reverse coded so that a higher number indicates more perceived control over exercise.
Baseline (Pre-Test) and Week 5 (Post-Test )
Exercise Self-efficacy
Tidsramme: Baseline (Pre-Test) and Week 5 (Post-Test )
Amount of confidence in ability to exercise.
Baseline (Pre-Test) and Week 5 (Post-Test )
Exercise Self-efficacy Beliefs - Time Composite
Tidsramme: Baseline (Pre-Test) and Week 5 (Post-Test )
Amount of confidence in ability to exercise when facing time constraints. Range from 1 (Very Sure) to 4 (Not sure at all). Reverse coded so that a higher number indicates more self-efficacy. 3 items, summed to form time-relevant composite scale.
Baseline (Pre-Test) and Week 5 (Post-Test )

Samarbejdspartnere og efterforskere

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

Sponsor

Brandeis University

Efterforskere

  • Ledende efterforsker: Margie Lachman, Ph.D., Brandeis University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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 (Faktiske)

1. juni 2015

Primær færdiggørelse (Faktiske)

1. oktober 2016

Studieafslutning (Faktiske)

1. oktober 2016

Datoer for studieregistrering

Først indsendt

13. april 2017

Først indsendt, der opfyldte QC-kriterier

19. april 2017

Først opslået (Faktiske)

24. april 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

14. januar 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. juli 2018

Sidst verificeret

1. juli 2018

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • WalkingIntentions #15147

Plan for individuelle deltagerdata (IPD)

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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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