Efficacy of StepAdd, a Personalized mHealth Intervention Based on Social Cognitive Theory to Increase Physical Activity Among Patients With Type 2 Diabetes Mellitus: Protocol for a Randomized Controlled Trial

Kayo Waki; Yuya Tsurutani; Hironori Waki; Syunpei Enomoto; Kosuke Kashiwabara; Akira Fujiwara; Kazuki Orime; Sho Kinguchi; Toshimasa Yamauchi; Nobuhito Hirawa; Kouichi Tamura; Yasuo Terauchi; Masaomi Nangaku; Kazuhiko Ohe

doi:10.2196/53514

Efficacy of StepAdd, a Personalized mHealth Intervention Based on Social Cognitive Theory to Increase Physical Activity Among Patients With Type 2 Diabetes Mellitus: Protocol for a Randomized Controlled Trial

JMIR Res Protoc. 2024 Feb 23:13:e53514. doi: 10.2196/53514.

Authors

Kayo Waki^{1

2

3}, Yuya Tsurutani⁴, Hironori Waki⁵, Syunpei Enomoto³, Kosuke Kashiwabara⁶, Akira Fujiwara⁷, Kazuki Orime⁸, Sho Kinguchi⁹, Toshimasa Yamauchi², Nobuhito Hirawa⁷, Kouichi Tamura⁹, Yasuo Terauchi¹⁰, Masaomi Nangaku¹¹, Kazuhiko Ohe^{1

3}

Affiliations

¹ Department of Biomedical Informatics, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.
² Department of Diabetes and Metabolic Diseases, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.
³ Department of Planning, Information and Management, The University of Tokyo Hospital, Tokyo, Japan.
⁴ Endocrinology and Diabetes Center, Yokohama Rosai Hospital, Yokohama, Japan.
⁵ Department of Metabolism and Endocrinology, Akita University Graduate School of Medicine, Akita, Japan.
⁶ Data Science Office, Clinical Research Promotion Center, The University of Tokyo Hospital, Tokyo, Japan.
⁷ Department of Nephrology and Hypertension, Yokohama City University Medical Center, Yokohama, Japan.
⁸ Department of Endocrinology and Diabetes, Yokohama City University Medical Center, Yokohama, Japan.
⁹ Department of Medical Science and Cardiorenal Medicine, Yokohama City University Graduate School of Medicine, Yokohama, Japan.
¹⁰ Department of Endocrinology and Metabolism, Yokohama City University Graduate School of Medicine, Yokohama, Japan.
¹¹ Division of Nephrology and Endocrinology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.

PMID: 38393770
PMCID: PMC10924262
DOI: 10.2196/53514

Abstract

Background: Increasing physical activity improves glycemic control in patients with type 2 diabetes (T2D). Mobile health (mHealth) interventions have been proven to increase exercise, but engagement often fades with time. As the 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 the use of goal-setting, barrier-identifying, and barrier-coping strategies, as well as automatic feedback functions. A single-arm pilot study of StepAdd among 33 patients with T2D showed a large increase in step count (mean change of 4714, SD 3638 daily steps or +86.7%), along with strong improvements in BMI (mean change of -0.3 kg/m²) and hemoglobin A_1c level (mean change of -0.79 percentage points).

Objective: In this study, we aim to investigate the efficacy and safety of StepAdd, an mHealth exercise support system for patients with T2D, via a large, long, and controlled follow-up to the pilot study.

Methods: This is a randomized, open-label, multicenter study targeting 160 patients with T2D from 5 institutions in Japan with a 24-week intervention. The intervention group will record daily step counts, body weight, and blood pressure using the SCT-based mobile app, StepAdd, and receive feedback about 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, body weight, and blood pressure using a non-SCT-based placebo app. Both groups will receive monthly consultations with a physician who will advise patients regarding lifestyle modifications and use 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 in hemoglobin A_1c values at 24 weeks. The secondary outcomes include other health measures, measurements of steps, measurements of other behavior changes, and assessments of app use. The trial began in January 2023 and is intended to be completed in December 2025.

Results: As of September 5, 2023, we had recruited 44 patients. We expect the trial to be completed by October 8, 2025, with the follow-up observation period being completed by December 31, 2025.

Conclusions: This trial will provide important evidence about the efficacy of an SCT-based mHealth intervention in improving physical activities and glycemic control in patients with T2D. If this study proves the intervention to be effective and safe, it could be a key step toward the integration of mHealth as part of the standard treatment received by patients with T2D in Japan.

Trial registration: Japan Registry of Clinical Trials (JRCT) jRCT2032220603; https://rctportal.niph.go.jp/en/detail?trial_id=jRCT2032220603.

International registered report identifier (irrid): DERR1-10.2196/53514.

Keywords: behavior change; digital therapeutics; exercise; mobile app; mobile phone; randomized controlled trial; social cognitive theory; type 2 diabetes mellitus.

©Kayo Waki, Yuya Tsurutani, Hironori Waki, Syunpei Enomoto, Kosuke Kashiwabara, Akira Fujiwara, Kazuki Orime, Sho Kinguchi, Toshimasa Yamauchi, Nobuhito Hirawa, Kouichi Tamura, Yasuo Terauchi, Masaomi Nangaku, Kazuhiko Ohe. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 23.02.2024.