Clinical trial NCT06135740: Impact of Nutrition, Sleep, and Physical Activity on Intellectual Function and Muscle Mass in Older Adults
Official title: Impact of Notifications on Nutrition, Sleep, and Physical Activity on Intellectual Function and Muscle Mass in OldeR Adults (INSPIOR)
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Cognition Disorders in Old Age
Cognitive Function
Frailty/Sarcopenia
MCI
Lead sponsor: Tokyo University
Sponsor class: OTHER
Collaborators: name: Google LLC.
First posted: 2023-11-18
Enrollment: 350
Sex: ALL
Minimum age (years): 65
Maximum age (years): 92
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this prospective, single site, interventional randomized control trial is to treat age related health conditions in adults older than 65 years and functional independence. The main question of the study is to answer the effectiveness of notification on activity, sleep, and nutrition based on wearable device Fitbit recorded data for the improvement of health conditions including intellectual property and physical function, compared to usual care. Participants in the intervention arm will be given a Fitbit Charge 5 device and asked to wear this for the duration of the study, including during sleep. The study intervention will run for 6 months. Notifications will be issued using a monitoring software in Japanese, and issued automatically to participants. Participants in the control arm will be given a routine care and health-related information. Researchers will compare cognitive performance, muscle mass and physical activity between the two groups to see if the notification based on Fitbit data would promote the health conditions of older adults.

Detailed description: This is a prospective, single site, interventional randomized control trial. The primary purpose is to treat age related health conditions. The current study is nested within an established cohort based in Kashiwa City in Japan, which consists of older adults living independently. The inclusion criteria of this study is age equal to or older than 65 years and functional independence (i.e., not requiring nursing care provided by long-term care insurance). The investigators plan to conduct a randomized controlled trial to test the effectiveness of notification based on Fitbit recorded data, used to prompt health and wellness actions on a variety of health outcomes, compared to usual care. On enrollment, baseline demographic and health information as well as baseline measurements for quality of life, and physical and mental health, will be collected. Subsequently, the study intervention will run for 6 months. Participants in the intervention arm will be given a Fitbit Charge 5 device and asked to wear this for the duration of the study, including during sleep. Participants will receive sessions to teach them how to use the Charge 5 device and access the information produced. Those who meet the above criteria for intervention will receive automatically generated notifications that include lifestyle recommendations. Notifications will be issued using a monitoring software in Japanese, and issued automatically as text alerts to participants. Participants will receive encouraging notifications to promote adherence and health condition. Participants in the control arm will be given a routine care and health-related information. Participants who fail to exhibit a behavior change in the week following the alert, or who are not engaging with the study (e.g., by not wearing the Fitbit device) will be followed up by phone by a member of the community research group. Researchers will compare cognitive performance and physical activity between the two groups to see if the notification based on Fitbit data would promote the health conditions of older adults. Results of this trial will be valuable for informing further implementation of wearable devices and related digital devices in elderly populations in Japan and other countries in the region.

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.

Primary outcomes:
measure: Executive function
timeFrame: 0 - 6 months
measure: General Cognition
timeFrame: 0 - 6 months
measure: Muscle mass
timeFrame: 0 - 6 months
Secondary outcomes:
measure: Amount of exercise
timeFrame: 0 - 6 months
measure: Amount of sleep
timeFrame: 0 - 6 months
Other outcomes:
measure: Frail/Sarcopenia
timeFrame: 0 - 6 months
measure: Malnutrition
timeFrame: 0 - 6 months
Locations:
city: Kashiwa
country: Japan
facility: Graduate School of Frontier Sciences, The University of Tokyo
state: Chiba
Study officials:
affiliation: Associate Professor
name: Tatsuhiro Hisatsune, PhD
role: PRINCIPAL_INVESTIGATOR
References: