Trials / Completed
CompletedNCT04858932
Geriatric Anorexia Study
Novel Digital Endpoints in Geriatric Anorexia
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 51 (actual)
- Sponsor
- Boston University · Academic / Other
- Sex
- All
- Age
- 65 Years – 85 Years
- Healthy volunteers
- Accepted
Summary
Reduction in appetite and/or food intake among older individuals is referred to as anorexia of aging (AOA, also known as Geriatric Anorexia). AOA is linked with myriad comorbidities associated with aging, contributes significantly to adverse health consequences in old age, and has been used as a predictor of morbidity and mortality. The overall aim of this study is to assess the feasibility and burden of the proposed in-laboratory and out-of-laboratory assessments to study Geriatric Anorexia. This will be accomplished with the use of questionnaires as well as devices that evaluate movement, metabolism, body weight composition, glucose levels, and nutritional scale.
Detailed description
This is a study to evaluate movement, metabolism, body weight composition, glucose levels, and nutritional scale in healthy adults. Subjects, age 65 to 85 years will be recruited. The proposed study will consist of an initial (in-clinic) intake visit on Day 1 where the subject will be screened and enrolled in the study after signing an informed consent document, followed by an at-home phase where the subject will wear a watch like device on one wrist. After training, the subject will return for their Day 8 in-clinic visit, where the subject will repeat some intake assessments and activities, as well as some additional standing and walking activities. The subject will then be asked to perform at-home activities and assessments with the use of a smart phone, digital food scale, smart body weight scale, and continuous glucose monitor, while continuing to wear the watch-like device and a movement measurement device around their waist (Days 8-21). A final in-clinic visit will take place on Day 21 for final assessments and device collection. A +/- 4 days will be allocated for the scheduling of all visits to accommodate subject's schedules and commitments. All in-laboratory activities will take place in the Laboratory for Human Neurobiology while in-home activities will be completed in the subject's home. The study procedures will be identical for all subjects for the three groups.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Continuous Glucose Monitor | a handheld reader and a wearable sensor placed on the back of the arm used to obtain glucose measurements |
| DEVICE | Wrist Actigraphy Device | a watch like wearable sensor |
| DEVICE | Food Weight Scale | a scale to measure food weight |
| DEVICE | Smart Body Weight Scale | a full body composition scale that provides fat and muscle mass, water retention, bone mass, and weight trends |
Timeline
- Start date
- 2021-04-27
- Primary completion
- 2021-12-15
- Completion
- 2021-12-15
- First posted
- 2021-04-26
- Last updated
- 2022-02-01
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT04858932. Inclusion in this directory is not an endorsement.