The feasibility and acceptability of a web-based physical activity for the heart (PATH) intervention designed to reduce the risk of heart disease among inactive African Americans: Protocol for a pilot randomized controlled trial.
Cardiometabolic risk
Physical activity
Physical activity tracker
Randomized controlled trial
Self-monitoring
Technology
Web-based
Journal
Contemporary clinical trials
ISSN: 1559-2030
Titre abrégé: Contemp Clin Trials
Pays: United States
ID NLM: 101242342
Informations de publication
Date de publication:
05 2021
05 2021
Historique:
received:
24
12
2020
revised:
24
03
2021
accepted:
26
03
2021
pubmed:
3
4
2021
medline:
25
9
2021
entrez:
2
4
2021
Statut:
ppublish
Résumé
Many studies have used the internet to promote physical activity (PA) in several settings, including the home environment, but few have been tailored for African Americans (AAs). To address this research gap, we conducted focus groups with AAs to inform the development of a web-based intervention, Physical Activity for The Heart (PATH), that leverages openly accessible platforms, such as YouTube, to promote PA in any setting. To describe the rationale and design of a pilot randomized clinical trial (RCT), that examines the feasibility and acceptability of the PATH intervention among 30 AA adults aged 40--70 years without history of cardiovascular disease. A 12-week, single-site, wait-listed RCT with subjects randomized 1:1 to either: 1) treatment group - participants receive the PATH intervention, including the online portal and twice a month phone calls from a PA coach, or 2) attention control group - participants receive a self-help PA handout and twice a month general health newsletter. All participants self-monitor step count using actigraphy. The primary outcomes of this 12-week, pilot RCT are recruitment, retention, and adherence to self-monitoring (Actigraph wear time) and the intervention protocol (PATH utilization). The secondary outcomes include changes in PA (step count, moderate-to-vigorous PA, exercise self-efficacy), and cardiometabolic risk (HbA1C, HDL, LDL, total cholesterol, type 2 diabetes risk score, percent body fat, weight, and waist circumference) from baseline to 12 weeks. This study will provide PATH intervention feasibility and acceptability data among inactive AA adults and will inform a future, full-scale RCT testing efficacy.
Sections du résumé
BACKGROUND
Many studies have used the internet to promote physical activity (PA) in several settings, including the home environment, but few have been tailored for African Americans (AAs). To address this research gap, we conducted focus groups with AAs to inform the development of a web-based intervention, Physical Activity for The Heart (PATH), that leverages openly accessible platforms, such as YouTube, to promote PA in any setting.
PURPOSE
To describe the rationale and design of a pilot randomized clinical trial (RCT), that examines the feasibility and acceptability of the PATH intervention among 30 AA adults aged 40--70 years without history of cardiovascular disease.
METHODS
A 12-week, single-site, wait-listed RCT with subjects randomized 1:1 to either: 1) treatment group - participants receive the PATH intervention, including the online portal and twice a month phone calls from a PA coach, or 2) attention control group - participants receive a self-help PA handout and twice a month general health newsletter. All participants self-monitor step count using actigraphy. The primary outcomes of this 12-week, pilot RCT are recruitment, retention, and adherence to self-monitoring (Actigraph wear time) and the intervention protocol (PATH utilization). The secondary outcomes include changes in PA (step count, moderate-to-vigorous PA, exercise self-efficacy), and cardiometabolic risk (HbA1C, HDL, LDL, total cholesterol, type 2 diabetes risk score, percent body fat, weight, and waist circumference) from baseline to 12 weeks.
CONCLUSIONS
This study will provide PATH intervention feasibility and acceptability data among inactive AA adults and will inform a future, full-scale RCT testing efficacy.
Identifiants
pubmed: 33798731
pii: S1551-7144(21)00116-6
doi: 10.1016/j.cct.2021.106380
pmc: PMC8180502
mid: NIHMS1690786
pii:
doi:
Types de publication
Clinical Trial Protocol
Journal Article
Research Support, N.I.H., Extramural
Langues
eng
Sous-ensembles de citation
IM
Pagination
106380Subventions
Organisme : NIA NIH HHS
ID : P30 AG024827
Pays : United States
Organisme : NHLBI NIH HHS
ID : R01 HL131583
Pays : United States
Organisme : NCATS NIH HHS
ID : UL1 TR001857
Pays : United States
Informations de copyright
Copyright © 2021 Elsevier Inc. All rights reserved.
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