MedDataX Logo

Impact of Nutrition, Sleep, and Physical Activity on Intellectual Function and Muscle Mass in Older Adults

NCT ID: NCT06135740

Last Updated: 2023-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

350 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-08

Study Completion Date

2024-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cognition Disorders in Old Age Cognitive Function Frailty/Sarcopenia MCI

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention

Notification on Nutrition, Sleep, and Physical Activity based on fitbit-based data

Group Type ACTIVE_COMPARATOR

Fitbit wearing, with notification for sleep, activity and nutrition based fitbit data

Intervention Type DEVICE

Notification on Nutrition, Sleep, and Physical Activity based on fitbit-based data, and Nutritional supplementation and Promotion of Exercise

Control

Regular Care

Group Type SHAM_COMPARATOR

Routine care

Intervention Type DEVICE

Regular Care on sleep, activity and nutrition

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Fitbit wearing, with notification for sleep, activity and nutrition based fitbit data

Notification on Nutrition, Sleep, and Physical Activity based on fitbit-based data, and Nutritional supplementation and Promotion of Exercise

Intervention Type DEVICE

Routine care

Regular Care on sleep, activity and nutrition

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

65 Years

Maximum Eligible Age

92 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Google LLC.

INDUSTRY

Sponsor Role collaborator

Tokyo University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Tatsuhiro Hisatsune

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Tatsuhiro Hisatsune, PhD

Role: PRINCIPAL_INVESTIGATOR

Associate Professor

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Graduate School of Frontier Sciences, The University of Tokyo

Kashiwa, Chiba, Japan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Japan

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

22-360

Identifier Type: -

Identifier Source: org_study_id