Impact of Notifi Cations on Nutrition, Sleep, and Physical Activity on Intellectual Function and Muscle Mass in OldeR Adults (INNSPIOR)
Study Details
Study Description
Brief Summary
The current study is nested within an established cohort based in Kashiwa City in Japan, which consists of older adults living independently in purpose built housing operated by Mitsui Fudosan, a large real estate company. 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). We plan to conduct a randomized controlled trial within the Kashiwa cohort 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. Results of this trial will be valuable for informing further implementation of Fitbits and related wearables in elderly populations in Japan and other countries in the region.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Intervention
|
Device: Notification for sleep, activity and nutrition based fitbit data
Those who meet the inclusion criteria for intervention will receive automatically generated notifications that include lifestyle recommendations.
|
| Sham Comparator: Control
|
Device: Notification for sleep, activity and nutrition based fitbit data
Those who meet the inclusion criteria for intervention will receive automatically generated notifications that include lifestyle recommendations.
|
Outcome Measures
Primary Outcome Measures
- Intellectual property and muscle mass [6 months]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Over 65 years of age.
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Living in Japan.
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Living independently with or without carer support.
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Able and willing to wear a Fitbit for the duration of the study (≥20 hours a day, including during sleep).
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Individuals that are able and willing to receive and act on interventions.
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Has capacity to consent to inclusion in the study.
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Smartphone access to allow Fitbit installation and setup.
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Has one or more of the following comorbidities:
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BMI <20 (65-69 years), <21.5 (≥70 years)
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Pre-frail or Frail: scoring 1-2 (pre-frail) or 3+ (frail) based on the FRAIL questionnaire (citation)
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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:
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Individuals receiving full time care in a care facility.
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Individuals that are unable to receive and/or act on interventions.
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Individuals who are existing wearable users, or who have prior experience using a wearable to manage their health.
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Individuals with uncontrolled hypertension, diabetes, CKD or with cardiac pacemakers and/or cardiovascular stent(s).
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Individuals who have any additional condition or situation that the Investigator (PI) or designee determines as inappropriate for participation in this study.
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Individuals with no comorbidities as defined above.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | TUniversity | Kashiwa | Chiba | Japan | 2778562 |
Sponsors and Collaborators
- Tokyo University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 22-360