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A Multimodal mHealth Intervention (FeatForward) to Improve Physical Activity Behavior in Patients with High Cardiometabolic Risk Factors: Rationale and Protocol for a Randomized Controlled Trial
BACKGROUND: Physical inactivity is one of the leading risk factors contributing to the rising rates of chronic diseases and has been associated with deleterious health outcomes in patients with chronic disease conditions. We developed a mobile phone app, FeatForward, to increase the level of physica...
Autores principales: | , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
JMIR Publications Inc.
2016
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4882414/ https://www.ncbi.nlm.nih.gov/pubmed/27174783 http://dx.doi.org/10.2196/resprot.5489 |
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author | Agboola, Stephen Palacholla, Ramya Sita Centi, Amanda Kvedar, Joseph Jethwani, Kamal |
author_facet | Agboola, Stephen Palacholla, Ramya Sita Centi, Amanda Kvedar, Joseph Jethwani, Kamal |
author_sort | Agboola, Stephen |
collection | PubMed |
description | BACKGROUND: Physical inactivity is one of the leading risk factors contributing to the rising rates of chronic diseases and has been associated with deleterious health outcomes in patients with chronic disease conditions. We developed a mobile phone app, FeatForward, to increase the level of physical activity in patients with cardiometabolic risk (CMR) factors. This intervention is expected to result in an overall improvement in patient health outcomes. OBJECTIVE: The objective of this study is to evaluate the effect of a mobile phone–based app, FeatForward, on physical activity levels and other CMR factors in patients with chronic conditions. METHODS: The study will be implemented as a 2-arm randomized controlled trial with 300 adult patients with chronic conditions over a 6-month follow-up period. Participants will be assigned to either the intervention group receiving the FeatForward app and standard care versus a control group who will receive only usual care. The difference in physical activity levels between the control group and intervention group will be measured as the primary outcome. We will also evaluate the effect of this intervention on secondary measures including clinical outcome changes in global CMR factors (glycated hemoglobin, fasting blood glucose, blood pressure, waist circumference, Serum lipids, C-reactive protein), health-related quality of life, health care usage, including attendance of scheduled clinic visits and hospitalizations, usability, and satisfaction, participant engagement with the FeatForward app, physician engagement with physician portal, and willingness to engage in physical activity. Instruments that will be used in evaluating secondary outcomes include the Short-Form (SF)-12, app usability and satisfaction questionnaires, physician satisfaction questionnaire. The intention-to-treat approach will be used to evaluate outcomes. All outcomes will be measured longitudinally at baseline, midpoint (3 months), and 6 months. Our primary outcome, physical activity, will be assessed by mixed-model analysis of variance with intervention assignment as between-group factor and time as within-subject factor. A similar approach will be used to analyze continuous secondary outcomes while categorical outcomes will be analyzed by chi-square test. RESULTS: The study is still in progress and we hope to have the results by the end of 2016. CONCLUSIONS: The mobile phone–based app, FeatForward, could lead to significant improvements in physical activity and other CMR factors in patients. |
format | Online Article Text |
id | pubmed-4882414 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2016 |
publisher | JMIR Publications Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-48824142016-06-08 A Multimodal mHealth Intervention (FeatForward) to Improve Physical Activity Behavior in Patients with High Cardiometabolic Risk Factors: Rationale and Protocol for a Randomized Controlled Trial Agboola, Stephen Palacholla, Ramya Sita Centi, Amanda Kvedar, Joseph Jethwani, Kamal JMIR Res Protoc Protocol BACKGROUND: Physical inactivity is one of the leading risk factors contributing to the rising rates of chronic diseases and has been associated with deleterious health outcomes in patients with chronic disease conditions. We developed a mobile phone app, FeatForward, to increase the level of physical activity in patients with cardiometabolic risk (CMR) factors. This intervention is expected to result in an overall improvement in patient health outcomes. OBJECTIVE: The objective of this study is to evaluate the effect of a mobile phone–based app, FeatForward, on physical activity levels and other CMR factors in patients with chronic conditions. METHODS: The study will be implemented as a 2-arm randomized controlled trial with 300 adult patients with chronic conditions over a 6-month follow-up period. Participants will be assigned to either the intervention group receiving the FeatForward app and standard care versus a control group who will receive only usual care. The difference in physical activity levels between the control group and intervention group will be measured as the primary outcome. We will also evaluate the effect of this intervention on secondary measures including clinical outcome changes in global CMR factors (glycated hemoglobin, fasting blood glucose, blood pressure, waist circumference, Serum lipids, C-reactive protein), health-related quality of life, health care usage, including attendance of scheduled clinic visits and hospitalizations, usability, and satisfaction, participant engagement with the FeatForward app, physician engagement with physician portal, and willingness to engage in physical activity. Instruments that will be used in evaluating secondary outcomes include the Short-Form (SF)-12, app usability and satisfaction questionnaires, physician satisfaction questionnaire. The intention-to-treat approach will be used to evaluate outcomes. All outcomes will be measured longitudinally at baseline, midpoint (3 months), and 6 months. Our primary outcome, physical activity, will be assessed by mixed-model analysis of variance with intervention assignment as between-group factor and time as within-subject factor. A similar approach will be used to analyze continuous secondary outcomes while categorical outcomes will be analyzed by chi-square test. RESULTS: The study is still in progress and we hope to have the results by the end of 2016. CONCLUSIONS: The mobile phone–based app, FeatForward, could lead to significant improvements in physical activity and other CMR factors in patients. JMIR Publications Inc. 2016-05-12 /pmc/articles/PMC4882414/ /pubmed/27174783 http://dx.doi.org/10.2196/resprot.5489 Text en ©Stephen Agboola, Ramya Sita Palacholla, Amanda Centi, Joseph Kvedar, Kamal Jethwani. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 12.05.2016. https://creativecommons.org/licenses/by/2.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0/ (https://creativecommons.org/licenses/by/2.0/) ), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on http://www.researchprotocols.org, as well as this copyright and license information must be included. |
spellingShingle | Protocol Agboola, Stephen Palacholla, Ramya Sita Centi, Amanda Kvedar, Joseph Jethwani, Kamal A Multimodal mHealth Intervention (FeatForward) to Improve Physical Activity Behavior in Patients with High Cardiometabolic Risk Factors: Rationale and Protocol for a Randomized Controlled Trial |
title | A Multimodal mHealth Intervention (FeatForward) to Improve Physical Activity Behavior in Patients with High Cardiometabolic Risk Factors: Rationale and Protocol for a Randomized Controlled Trial |
title_full | A Multimodal mHealth Intervention (FeatForward) to Improve Physical Activity Behavior in Patients with High Cardiometabolic Risk Factors: Rationale and Protocol for a Randomized Controlled Trial |
title_fullStr | A Multimodal mHealth Intervention (FeatForward) to Improve Physical Activity Behavior in Patients with High Cardiometabolic Risk Factors: Rationale and Protocol for a Randomized Controlled Trial |
title_full_unstemmed | A Multimodal mHealth Intervention (FeatForward) to Improve Physical Activity Behavior in Patients with High Cardiometabolic Risk Factors: Rationale and Protocol for a Randomized Controlled Trial |
title_short | A Multimodal mHealth Intervention (FeatForward) to Improve Physical Activity Behavior in Patients with High Cardiometabolic Risk Factors: Rationale and Protocol for a Randomized Controlled Trial |
title_sort | multimodal mhealth intervention (featforward) to improve physical activity behavior in patients with high cardiometabolic risk factors: rationale and protocol for a randomized controlled trial |
topic | Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4882414/ https://www.ncbi.nlm.nih.gov/pubmed/27174783 http://dx.doi.org/10.2196/resprot.5489 |
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