Impact of Nutrition, Sleep, and Physical Activity on Intellectual Function and Muscle Mass in Older Adults
Launched by TOKYO UNIVERSITY · Nov 13, 2023
Trial Information
Current as of October 26, 2025
Enrolling by invitation
Keywords
ClinConnect Summary
This is a 6-month, single-site randomized trial in Kashiwa, Japan, to see if automatic health tips based on data from a Fitbit device can help older adults with frailty, sarcopenia (muscle loss), or mild cognitive changes improve thinking skills, muscle mass, and daily activity. People will be assigned by chance to either use a Fitbit Charge 5 with automated reminders about sleep, activity, and nutrition, or to receive usual care without the reminders. The study will compare thinking abilities (like memory and problem-solving), muscle mass, and how much people move and sleep.
Eligible participants are adults aged 65 to 92 who live independently in Japan and can wear a Fitbit most of the day (including while sleeping) and have a smartphone. They must be willing to participate and able to consent. Exclusions include those in full-time care, people who already regularly wear a health wearable, or certain health conditions (like uncontrolled high blood pressure, diabetes, kidney disease, or pacemakers). If you’re in the intervention group, you’ll get training on using the device and will receive Japanese-language notifications for 6 months. If engagement drops or you stop wearing the device, study staff may follow up by phone. Results aren’t available yet, but the study aims to learn whether wearable-based notifications can support health in older adults.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Over 65 years of age.
- • Living in Japan.
- • Living independently with or without carer support.
- • Able and willing to wear a Fitbit for the duration of the study (≥20 hours a day, including during sleep).
- • Individuals that are able and willing to receive and act on interventions.
- • Has capacity to consent to inclusion in the study.
- • Smartphone access to allow Fitbit installation and setup.
- * Has one or more of the following comorbidities:
- • BMI \<20 (65-69 years), \<21.5 (≥70 years)
- • Pre-frail or Frail: scoring 1-2 (pre-frail) or 3+ (frail) based on the FRAIL questionnaire
- • Sarcopenia: low grip strength (female \<18 kg, male \<28 kg); Gait speed (\< 1m/s); low Skeletal Muscle mass Index (female 5.7 kg/m2; male 7 kg/m2)
- Exclusion Criteria:
- • Individuals receiving full time care in a care facility.
- • Individuals that are unable to receive and/or act on interventions.
- • Individuals who are existing wearable users, or who have prior experience using a wearable to manage their health.
- • Individuals with uncontrolled hypertension, diabetes, CKD or with cardiac pacemakers and/or cardiovascular stent(s).
- • Individuals who have any additional condition or situation that the Investigator (PI) or designee determines as inappropriate for participation in this study.
- • Individuals with no comorbidities as defined above.
About Tokyo University
Tokyo University, a premier institution in Japan, is at the forefront of clinical research and innovation, dedicated to advancing medical science and improving patient care. Renowned for its rigorous academic environment and cutting-edge research facilities, the university collaborates with leading experts across various disciplines to conduct clinical trials that address critical health challenges. With a strong commitment to ethical standards and patient safety, Tokyo University aims to translate scientific discoveries into effective therapies, contributing to global health advancements and fostering a robust pipeline of novel treatments.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Kashiwa, Chiba, Japan
Kashiwa, Chiba, Japan
Patients applied
Trial Officials
Tatsuhiro Hisatsune, PhD
Principal Investigator
Associate Professor
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported