Influencing basic behavioral mechanisms of action while targeting daily walking in sedentary adults at risk for cardiovascular disease: randomised factorial design protocol

Introduction Cardiovascular disease (CVD) is the leading cause of mortality worldwide, though it may be prevented by increasing physical activity (PA). When behaviour change techniques (BCTs) are bundled together, they increase PA, though which individual BCTs increase PA (and the behavioural mechan...

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Main Authors: Karina W Davidson, Ying Kuen Cheung, Joan Duer-Hefele, Jerry Suls, Ashley M Goodwin, Samantha Gordon, Ravneet Sahni, Frank Vicari, Kaitlyn Accardi, Salvatore Crusco, Ciaran Friel, Elizabeth A Vrany
Format: Article
Language:English
Published: BMJ Publishing Group 2025-01-01
Series:BMJ Open
Online Access:https://bmjopen.bmj.com/content/15/1/e080307.full
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author Karina W Davidson
Ying Kuen Cheung
Joan Duer-Hefele
Jerry Suls
Ashley M Goodwin
Samantha Gordon
Ravneet Sahni
Frank Vicari
Kaitlyn Accardi
Salvatore Crusco
Ciaran Friel
Elizabeth A Vrany
author_facet Karina W Davidson
Ying Kuen Cheung
Joan Duer-Hefele
Jerry Suls
Ashley M Goodwin
Samantha Gordon
Ravneet Sahni
Frank Vicari
Kaitlyn Accardi
Salvatore Crusco
Ciaran Friel
Elizabeth A Vrany
author_sort Karina W Davidson
collection DOAJ
description Introduction Cardiovascular disease (CVD) is the leading cause of mortality worldwide, though it may be prevented by increasing physical activity (PA). When behaviour change techniques (BCTs) are bundled together, they increase PA, though which individual BCTs increase PA (and the behavioural mechanism of action (MoA) responsible for said increase) have not been studied. The aim of this study is to conduct a randomised factorial experiment to determine which of four BCTs significantly engage the proposed MoA—self-efficacy for PA—in adults at risk for CVD.Methods and analysis Eight hundred and twenty sedentary adults (18–74 years old) at risk for CVD will be recruited between September 2022 and June 2025 to a fully remote, 24-week randomised BCT intervention. To identify those who might benefit from this intervention, we define self-reported walking <7500 steps per day as ‘sedentary'. Following a 4-week run-in period to confirm sedentary behaviour and adherence to the study protocol, 624 eligible participants will be randomised to an 8-week intervention period. A full factorial randomised experiment will be conducted with 16 possible conditions: one will receive no BCTs (no-BCT condition), another will receive all four, and 14 will receive a unique combination of BCTs. During the intervention, participants will receive their randomised daily BCT(s) via text message. Daily steps will be continuously measured using an activity tracker. Self-efficacy for PA will be assessed bi-weekly via the Self-Efficacy for Walking Scale–Duration. Participants will complete a 12-week post-intervention follow-up period where steps will be monitored despite no BCTs being delivered. BCT(s) associated with increased daily step counts and increased self-efficacy for PA between run-in and study completion (week 12 of follow-up) will be determined alongside whether or not self-efficacy for PA mediates the association between each BCT and increased walking.Ethics and dissemination This trial was approved by the Northwell Health Institutional Review Board. The full factorial experimental trial results will be published in a peer-reviewed journal. Data from this clinical trial will be made available on reasonable request.Trial registration number clinicaltrials.gov; Identifier: NCT05425641, 06/21/2022
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spelling doaj-art-2e573dfadb4d429b956934f825f4dae42025-08-20T01:47:37ZengBMJ Publishing GroupBMJ Open2044-60552025-01-0115110.1136/bmjopen-2023-080307Influencing basic behavioral mechanisms of action while targeting daily walking in sedentary adults at risk for cardiovascular disease: randomised factorial design protocolKarina W Davidson0Ying Kuen Cheung1Joan Duer-Hefele2Jerry Suls3Ashley M Goodwin4Samantha Gordon5Ravneet Sahni6Frank Vicari7Kaitlyn Accardi8Salvatore Crusco9Ciaran Friel10Elizabeth A Vrany11Feinstein Institutes for Medical Research, New Hyde Park, New York, USAColumbia University Mailman School of Public Health, New York, New York, USANorthwell Health, New Hyde Park, New York, USANorthwell Health, New Hyde Park, New York, USANorthwell Health, New Hyde Park, New York, USAFeinstein Institutes for Medical Research, New Hyde Park, New York, USANorthwell Health, New Hyde Park, New York, USANorthwell Health, New Hyde Park, New York, USANorthwell Health, New Hyde Park, New York, USANorthwell Health, New Hyde Park, New York, USANorthwell Health, New Hyde Park, New York, USANorthwell Health, New Hyde Park, New York, USAIntroduction Cardiovascular disease (CVD) is the leading cause of mortality worldwide, though it may be prevented by increasing physical activity (PA). When behaviour change techniques (BCTs) are bundled together, they increase PA, though which individual BCTs increase PA (and the behavioural mechanism of action (MoA) responsible for said increase) have not been studied. The aim of this study is to conduct a randomised factorial experiment to determine which of four BCTs significantly engage the proposed MoA—self-efficacy for PA—in adults at risk for CVD.Methods and analysis Eight hundred and twenty sedentary adults (18–74 years old) at risk for CVD will be recruited between September 2022 and June 2025 to a fully remote, 24-week randomised BCT intervention. To identify those who might benefit from this intervention, we define self-reported walking <7500 steps per day as ‘sedentary'. Following a 4-week run-in period to confirm sedentary behaviour and adherence to the study protocol, 624 eligible participants will be randomised to an 8-week intervention period. A full factorial randomised experiment will be conducted with 16 possible conditions: one will receive no BCTs (no-BCT condition), another will receive all four, and 14 will receive a unique combination of BCTs. During the intervention, participants will receive their randomised daily BCT(s) via text message. Daily steps will be continuously measured using an activity tracker. Self-efficacy for PA will be assessed bi-weekly via the Self-Efficacy for Walking Scale–Duration. Participants will complete a 12-week post-intervention follow-up period where steps will be monitored despite no BCTs being delivered. BCT(s) associated with increased daily step counts and increased self-efficacy for PA between run-in and study completion (week 12 of follow-up) will be determined alongside whether or not self-efficacy for PA mediates the association between each BCT and increased walking.Ethics and dissemination This trial was approved by the Northwell Health Institutional Review Board. The full factorial experimental trial results will be published in a peer-reviewed journal. Data from this clinical trial will be made available on reasonable request.Trial registration number clinicaltrials.gov; Identifier: NCT05425641, 06/21/2022https://bmjopen.bmj.com/content/15/1/e080307.full
spellingShingle Karina W Davidson
Ying Kuen Cheung
Joan Duer-Hefele
Jerry Suls
Ashley M Goodwin
Samantha Gordon
Ravneet Sahni
Frank Vicari
Kaitlyn Accardi
Salvatore Crusco
Ciaran Friel
Elizabeth A Vrany
Influencing basic behavioral mechanisms of action while targeting daily walking in sedentary adults at risk for cardiovascular disease: randomised factorial design protocol
BMJ Open
title Influencing basic behavioral mechanisms of action while targeting daily walking in sedentary adults at risk for cardiovascular disease: randomised factorial design protocol
title_full Influencing basic behavioral mechanisms of action while targeting daily walking in sedentary adults at risk for cardiovascular disease: randomised factorial design protocol
title_fullStr Influencing basic behavioral mechanisms of action while targeting daily walking in sedentary adults at risk for cardiovascular disease: randomised factorial design protocol
title_full_unstemmed Influencing basic behavioral mechanisms of action while targeting daily walking in sedentary adults at risk for cardiovascular disease: randomised factorial design protocol
title_short Influencing basic behavioral mechanisms of action while targeting daily walking in sedentary adults at risk for cardiovascular disease: randomised factorial design protocol
title_sort influencing basic behavioral mechanisms of action while targeting daily walking in sedentary adults at risk for cardiovascular disease randomised factorial design protocol
url https://bmjopen.bmj.com/content/15/1/e080307.full
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