Accepted for/Published in: JMIR Research Protocols
Date Submitted: Oct 10, 2023
Date Accepted: Jan 4, 2024
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Efficacy of StepAdd, a personalized mHealth intervention based on social cognitive theory to increase physical activity among type 2 diabetes patients: protocol for a randomized controlled trial
ABSTRACT
Background:
Increasing physical activity improves glycemic control in type 2 diabetes mellitus (T2D) patients. Mobile health (mHealth) interventions have been proven to increase exercise, but engagement often fades with time. Because use of health behavior theory in mHealth design can increase effectiveness, we developed StepAdd, an mHealth intervention based on the constructs of Social Cognitive Theory (SCT). StepAdd improves exercise behavior self-efficacy and self-regulation through use of goal setting, barrier-identifying and barrier-coping strategies, and automatic feedback functions.
Objective:
In this study, we aim to investigate the efficacy and safety of StepAdd, a mobile health exercise support system for T2D patients.
Methods:
This is a randomized, open-label, multi-center study targeting 160 T2D patients from five institutions in Japan with a 24-week intervention. The intervention group will record daily step counts, body weight (BW), and blood pressure (BP) using the SCT-based mobile application (app) StepAdd and receive feedback on these measurements. In addition, they will set weekly step count goals, identify personal barriers to walking, and define strategies to overcome these barriers. The control group will record daily step counts, BW, and BP using a non-SCT-based placebo app. Both groups will receive monthly consultations with a physician who will advise patients on lifestyle modifications and usage of the app. The 24-week intervention period will be followed by a 12-week observational period to investigate the sustainability of the intervention’s effects. The primary outcome is between-group difference in the change of HbA1c value at 24 weeks. The secondary outcomes include other health measures, measurements of steps, measurements of other behavior changes, and assessments of app usage. The trial began in January 2023 and is intended to conclude in December 2025.
Results:
As of September 5, 2023, we have recruited 44 patients. We expect the trial to conclude by October 8, 2025, with the follow-up observation period concluding by December 31, 2025.
Conclusions:
This trial will provide important evidence on the efficacy of an SCT-based mHealth intervention in improving physical activities and glycemic control in type 2 diabetes patients. If this study proves the intervention to be effective and safe, it could be a key step towards the integration of mHealth as part of the standard treatment received by diabetes patients in Japan. Clinical Trial: Trial Registration: jRCT2032220603
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