The Effect of a mHealth App (KENPO-app) for Specific Health Guidance on Weight Changes in Adults With Obesity and Hypertension: Pilot Randomized Controlled Trial (Preprint)

BACKGROUND Commercial smartphone apps that promote self-monitoring of weight loss are widely available. The development of disease-specific apps has begun, but there is no app for specific health guidance (SHG) to prevent metabolic syndrome, type 2 diabetes, and cardiovascular diseases in middle-aged adults in Japan. OBJECTIVE This study aimed to determine the efficacy of an SHG mobile health app in facilitating weight loss in Japanese adults with obesity and hypertension. METHODS In a 12-week, statistician-blinded, randomized parallel controlled trial, 78 overweight and obese men aged 40-69 years were assigned in a 1:1 ratio to either the usual support plus KENPO-app group (intervention group) or the active control group. KENPO-app (release April 10, 2019; OMRON Healthcare Co., Ltd.) was developed by the study team and focus groups and uses behavior change techniques (ie, self-monitoring and goal-setting theory). This app was developed for SHG based on the four specific health checkups and guidance system in Japan: (1) focusing primarily on achieving the target (weight loss of ≥2 kg); (2) assessing healthy eating, exercise habits, smoking habits, relaxation, and self-weighing; (3) providing information on the results of specific health checkups; and (4) starting an intervention period of 6 months with the interim assessment at 3 months. The initial assessment explored the following: personality traits (4 types), health checkup data concerns (10 items), symptom concerns (10 items), and the aim of the intervention (weight loss, improving fitness, symptoms, laboratory data). Chatbot-supported health information on health and health behavior was selected from 392 quizzes based on app data and was provided to participants. The KENPO-app had chatbot-supported feedback and information provision combined with a self-monitoring tool (weight, steps, and blood pressure). Data on active exercise, healthy eating, and healthy lifestyle habits were obtained using a web-based self-administered questionnaire at baseline and 12 weeks. RESULTS The trial’s retention rate was 95% (74/78). The adherence to daily self-weighing, wearing the pedometer, and blood pressure monitoring in the KENPO-app group was significantly higher than those in the active control group. Compared with the active control group, the median body weight and BMI of the intervention group significantly decreased at 3 months (–0.4, IQR –2.0 to 0.6 kg vs –1.1, IQR –2.7 to –0.5 kg; P=.03; –0.1, IQR –0.6 to 0.3 kg vs –0.4, IQR –0.8 to –0.2 kg; P=.02, respectively). The intervention increased the percentage of participants who self-reported taking ≥8000 steps, eating vegetables before rice, eating slowly, and relaxing. Personality traits were associated with the degree of weight loss in the intervention group. CONCLUSIONS The SHG-specific KENPO-app was feasible and induced modest but significant weight loss in adults with obesity. CLINICALTRIAL University Hospital Medical Information Network Center UMIN000046263; https://tinyurl.com/bderys3b