- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03124563
Planning the Next Steps: Using an Implementation Intention Approach to Increase Daily Walking
19 juli 2018 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
63
Fas
- Inte tillämpbar
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
35 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
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.
|
|
Experimentell: 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.
|
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Steps
Tidsram: 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
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Cognitive Composite Score
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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 )
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Margie Lachman, Ph.D., Brandeis University
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- Robinson SA, Lachman ME. Perceived Control and Aging: A Mini-Review and Directions for Future Research. Gerontology. 2017;63(5):435-442. doi: 10.1159/000468540. Epub 2017 Apr 8.
- Robinson, S. A. & Lachman, M. E. (2016). Perceived Control and Behavior Change: A Personalized Approach. In F. Infurna & J. Reich (Eds.), Perceived Control: Theory, Research, and Practice in the First 50 Years (pp. 201-227). New York, New York: Oxford University Press.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 juni 2015
Primärt slutförande (Faktisk)
1 oktober 2016
Avslutad studie (Faktisk)
1 oktober 2016
Studieregistreringsdatum
Först inskickad
13 april 2017
Först inskickad som uppfyllde QC-kriterierna
19 april 2017
Första postat (Faktisk)
24 april 2017
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
14 januari 2019
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
19 juli 2018
Senast verifierad
1 juli 2018
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- WalkingIntentions #15147
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Nej
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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