TY - JOUR
T1 - Biofeedback and Digitalized Motivational Interviewing to Increase Daily Physical Activity: Series of Factorial N-of-1 Randomized Controlled Trials Piloting the Precious App
AU - Nurmi, Johanna
AU - Knittle, Keegan
AU - Naughton, Felix
AU - Sutton, Stephen
AU - Ginchev, Todor
AU - Khattak, Fidaullah
AU - Castellano-Tejedor, Carmina
AU - Lusilla-Palacios, Pilar
AU - Ravaja, Niklas
AU - Haukkala, Ari
N1 - Funding Information:
The authors are most grateful to the study participants for their time and effort. They want to thank the full Precious project team for their contributions during the development of the broader Precious app and external devices and Dr Daniel Powell and Dr Francesco Fusco for their statistical advice. The authors sincerely thank the anonymous peer reviewers and editors for their contributions. The research leading to these results has received funding from the European Community Seventh Framework Programme for the Precious project under grant agreement 611366, the Doctoral Programme in Social Sciences of the University of Helsinki, the KAUTE Foundation, and the Yrjö Jahnsson Foundation.
Publisher Copyright:
© 2023 JMIR Publications Inc.. All rights reserved.
PY - 2023/1
Y1 - 2023/1
N2 - Background: Insufficient physical activity is a public health concern. New technologies may improve physical activity levels and enable the identification of its predictors with high accuracy. The Precious smartphone app was developed to investigate the effect of specific modular intervention elements on physical activity and examine theory-based predictors within individuals. Objective: This study pilot-tested a fully automated factorial N-of-1 randomized controlled trial (RCT) with the Precious app and examined whether digitalized motivational interviewing (dMI) and heart rate variability–based biofeedback features increased objectively recorded steps. The secondary aim was to assess whether daily self-efficacy and motivation predicted within-person variability in daily steps. Methods: In total, 15 adults recruited from newspaper advertisements participated in a 40-day factorial N-of-1 RCT. They installed 2 study apps on their phones: one to receive intervention elements and one to collect ecological momentary assessment (EMA) data on self-efficacy, motivation, perceived barriers, pain, and illness. Steps were tracked using Xiaomi Mi Band activity bracelets. The factorial design included seven 2-day biofeedback interventions with a Firstbeat Bodyguard 2 (Firstbeat Technologies Ltd) heart rate variability sensor, seven 2-day dMI interventions, a wash-out day after each intervention, and 11 control days. EMA questions were sent twice per day. The effects of self-efficacy, motivation, and the interventions on subsequent steps were analyzed using within-person dynamic regression models and aggregated data using longitudinal multilevel modeling (level 1: daily observations; level 2: participants). The analyses were adjusted for covariates (ie, within- and between-person perceived barriers, pain or illness, time trends, and recurring events). Results: All participants completed the study, and adherence to activity bracelets and EMA measurements was high. The implementation of the factorial design was successful, with the dMI features used, on average, 5.1 (SD 1.0) times of the 7 available interventions. Biofeedback interventions were used, on average, 5.7 (SD 1.4) times out of 7, although 3 participants used this feature a day later than suggested and 1 did not use it at all. Neither within- nor between-person analyses revealed significant intervention effects on step counts. Self-efficacy predicted steps in 27% (4/15) of the participants. Motivation predicted steps in 20% (3/15) of the participants. Aggregated data showed significant group-level effects of day-level self-efficacy (B=0.462; P<.001), motivation (B=0.390; P<.001), and pain or illness (B=−1524; P<.001) on daily steps. Conclusions: The automated factorial N-of-1 trial with the Precious app was mostly feasible and acceptable, especially the automated delivery of the dMI components, whereas self-conducted biofeedback measurements were more difficult to time correctly. The findings suggest that changes in self-efficacy and motivation may have same-day effects on physical activity, but the effects vary across individuals. This study provides recommendations based on the lessons learned on the implementation of factorial N-of-1 RCTs.
AB - Background: Insufficient physical activity is a public health concern. New technologies may improve physical activity levels and enable the identification of its predictors with high accuracy. The Precious smartphone app was developed to investigate the effect of specific modular intervention elements on physical activity and examine theory-based predictors within individuals. Objective: This study pilot-tested a fully automated factorial N-of-1 randomized controlled trial (RCT) with the Precious app and examined whether digitalized motivational interviewing (dMI) and heart rate variability–based biofeedback features increased objectively recorded steps. The secondary aim was to assess whether daily self-efficacy and motivation predicted within-person variability in daily steps. Methods: In total, 15 adults recruited from newspaper advertisements participated in a 40-day factorial N-of-1 RCT. They installed 2 study apps on their phones: one to receive intervention elements and one to collect ecological momentary assessment (EMA) data on self-efficacy, motivation, perceived barriers, pain, and illness. Steps were tracked using Xiaomi Mi Band activity bracelets. The factorial design included seven 2-day biofeedback interventions with a Firstbeat Bodyguard 2 (Firstbeat Technologies Ltd) heart rate variability sensor, seven 2-day dMI interventions, a wash-out day after each intervention, and 11 control days. EMA questions were sent twice per day. The effects of self-efficacy, motivation, and the interventions on subsequent steps were analyzed using within-person dynamic regression models and aggregated data using longitudinal multilevel modeling (level 1: daily observations; level 2: participants). The analyses were adjusted for covariates (ie, within- and between-person perceived barriers, pain or illness, time trends, and recurring events). Results: All participants completed the study, and adherence to activity bracelets and EMA measurements was high. The implementation of the factorial design was successful, with the dMI features used, on average, 5.1 (SD 1.0) times of the 7 available interventions. Biofeedback interventions were used, on average, 5.7 (SD 1.4) times out of 7, although 3 participants used this feature a day later than suggested and 1 did not use it at all. Neither within- nor between-person analyses revealed significant intervention effects on step counts. Self-efficacy predicted steps in 27% (4/15) of the participants. Motivation predicted steps in 20% (3/15) of the participants. Aggregated data showed significant group-level effects of day-level self-efficacy (B=0.462; P<.001), motivation (B=0.390; P<.001), and pain or illness (B=−1524; P<.001) on daily steps. Conclusions: The automated factorial N-of-1 trial with the Precious app was mostly feasible and acceptable, especially the automated delivery of the dMI components, whereas self-conducted biofeedback measurements were more difficult to time correctly. The findings suggest that changes in self-efficacy and motivation may have same-day effects on physical activity, but the effects vary across individuals. This study provides recommendations based on the lessons learned on the implementation of factorial N-of-1 RCTs.
KW - activity bracelet
KW - activity tracker
KW - automated
KW - behavior change
KW - biofeedback
KW - daily steps
KW - digitalized
KW - ecological momentary assessment
KW - intensive longitudinal multilevel modeling
KW - intervention
KW - mobile phone
KW - motivational interviewing
KW - N-of-1
KW - self-efficacy
KW - self-regulation
KW - smartphone
KW - within-person design
UR - http://www.scopus.com/inward/record.url?scp=85180121062&partnerID=8YFLogxK
U2 - 10.2196/34232
DO - 10.2196/34232
M3 - Article
AN - SCOPUS:85180121062
SN - 2561-326X
VL - 7
JO - JMIR Formative Research
JF - JMIR Formative Research
IS - 1
M1 - e34232
ER -