HealthyGAS2NCT05211973
Geriatric Anorexia Study 2.0
An observational study of Healthy and Frailty, run by Boston University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- What is being tested?
- Wrist Actigraphy Device, Smart Body Weight Scale and Chair Scale
- Type of treatment
- Medical device
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Mar 2022to 7 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Healthy Adults
Who may be able to join
None listed.
Who cannot join
- Treatment with an investigational drug within 30 days of enrollment
- Moderate to severe alcohol use disorder diagnosis within 6 months of the screening as disclosed by the subject
- Participants who are investigational site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or participants who are Boston University/Boston Medical Center (BU/BMC) employees directly involved in the conduct of the study
- Inability to comply with study requirements
- Life expectancy of less than 6 months, or actively enrolled in a palliative care program
- Has any clinically significant medical disorder, condition, disease, or clinically significant finding at screening that precludes subject's participation in study activities
Show all 10Show fewer
- Participants with electronic implant such as pacemaker etc., due to Bioelectric Impedance Analysis (BIA) body composition devices (Tanita, Smart body scale) using tiny electrical signal for measurements
- At an increased risk of COVID-19 as determined by the Laboratory for Human Neurobiology COVID-19 Human Subject Risk Assessment Survey
- Temperature equal to or above 100.4 degrees F
- Modified Barthel Index of <40
Trial locations and contacts
1 site in 1 country.
United States1 site
Evans Biomedical Research Center
Boston, Massachusetts, 02118
About this study
Official title: Developing Novel Digital Endpoints in Anorexia of Aging in Elderly Populations Residing in Long Term Care (LTC), Nursing Home, or Assisted Living Facilities
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 compare feasibility of body weight, body fat, body composition and activity assessments in elderly subjects in long-term care (LTC), nursing home, or assisted living facilities. This will be accomplished through the use of questionnaires in addition to devices that evaluate movement, body composition, and body weight.
Read the detailed description
The overall aim of this study is to compare feasibility of body weight, body fat, body composition and activity assessments in elderly subjects in long-term care (LTC), nursing home, or assisted living facilities. This will be accomplished through the use of questionnaires in addition to devices that evaluate movement, body composition, and body weight.
The proposed study will consist of an initial intake visit on Day 1, followed by an at-home (i.e. LTC facility, nursing home, and/or assisted living facility) phase where the participant will wear two watch like devices one on each wrist and answer two questions on paper each day. There will be a second visit on day 8 where the participant will complete additional questionnaires and assessments. The participant will continue wearing the wrist-worn devices for days 9-14, with a final visit on day 15 for final assessments and device collection. A window of +/- 3 days will be allocated for the scheduling of all visits to accommodate participant's schedules and commitments. Activities will take place in the care facility where the participant resides, or the Laboratory for Human Neurobiology for those that will commute. The study procedures will be identical for all participants for all Frailty groups.
- Being tested
- Wrist Actigraphy Device, Smart Body Weight Scale, Chair Scale, Handheld Body Fat Percentage Device, Bioelectric Impedance Analysis Scale
- Keywords
- Healthy, Wearable Devices, Geriatric Anorexia, Frail
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wrist Actigraphy DeviceDevice
Also called Geneactiv Watch
a watch like wearable sensor
Smart Body Weight ScaleDevice
Also called Renpho
a full body composition scale that provides fat and muscle mass, water retention, bone mass, and weight trends (conducted based on participant's abilities)
Chair ScaleDevice
Also called Meilestone
a wheel-chair compatible scale to measure body weight
Handheld Body Fat Percentage DeviceDevice
Also called Omron
a handheld device that measures body fat percentage
Bioelectric Impedance Analysis ScaleDevice
Also called Tanita
a research-grade full body composition scale that provides fat and muscle mass, water retention, bone mass, and weight trends (conducted based on participant's abilities)
| Study group | Role | What they receive |
|---|---|---|
| Fried Frailty Phenotype 0 | Those who are considered Robust under the Fried Frailty Criteria. Sensor technology and digital measures will be used to evaluate movement and body weight composition in healthy adults. Receives: Device: Wrist Actigraphy Device; Device: Smart Body Weight Scale; Device: Chair Scale; Device: Handheld Body Fat Percentage Device; Device: Bioelectric Impedance Analysis Scale | |
| Fried Frailty Phenotype 1-2 | Those who are considered Intermediate/Pre-frail under the Fried Frailty Criteria. Sensor technology and digital measures will be used to evaluate movement and body weight composition in healthy adults. Receives: Device: Wrist Actigraphy Device; Device: Smart Body Weight Scale; Device: Chair Scale; Device: Handheld Body Fat Percentage Device; Device: Bioelectric Impedance Analysis Scale | |
| Fried Frailty Phenotype 3+ | Those who are considered Frail under the Fried Frailty Criteria. Sensor technology and digital measures will be used to evaluate movement and body weight composition in healthy adults. Receives: Device: Wrist Actigraphy Device; Device: Smart Body Weight Scale; Device: Chair Scale; Device: Handheld Body Fat Percentage Device; Device: Bioelectric Impedance Analysis Scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the use of accelerometry in an elderly cohort based in a LTC/nursing home/assisted-living setting
Two GENEActiv watches will be used (one on each wrist) at a sampling rate of 50 Hz to measure movement in the x, y, and z direction across the study period.
Measured: 2 weeks +/- 3 days
Assess the use of a smart standing scale for body weight and composition assessment in an elderly cohort based in a LTC/nursing home/assisted-living setting (based on participant's abilities).
A body weight composition scale will be used to completion of daily weight measurement and track body weight in kilograms (kg) throughout the study (based on participant's abilities).
Measured: 2 weeks +/- 3 days
Assess the use of a chair scale for body weight assessment in an elderly cohort based in a LTC/nursing home/assisted-living setting.
A chair scale will be used during study staff visits to measure and track body weight.
Measured: 2 weeks +/- 3 days
Assess the use of a handheld body fat assessment tool for body fat percentage assessment in an elderly cohort based in a LTC/nursing home/assisted-living setting.
A handheld body fat assessment tool will be used during study staff visits to measure body fat percentage.
Measured: 2 weeks +/- 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2022
- Study start28 Mar 2022
- Primary completion7 Sep 2022
- Study completion7 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kevin C Thomas, PhD, MBA, Principal investigator, Principal Investigator, Boston University, Department of Anatomy & Neurobiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05211973
- Sponsor's protocol ID
- H-42048
- Acronym
- GAS2
- Status last verified
- Sep 2022
- First submitted
- 13 Jan 2022
- Last updated
- 28 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Camerlingo N, Wicker M, Psaltos DJ, Shaafi-Kabiri N, Zhang H, Messere A, Messina I, Hayden Z, Kelly M, Kamat G, Karahanoglu FI, Demanuele C, Santamaria M, Caouette D, Thomas KC. Leveraging Digital Health Technologies to Assess Older Adults' Frailty and Nutritional Status: Two Cross-Sectional Studies. JMIR Aging. 2026 Apr 17;9:e77816. doi: 10.2196/77816.
PubMed 41860332
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing Novel Digital Endpoints in Anorexia of Aging in Elderly Populations Residing in Long Term Care (LTC), Nursing Home, or Assisted Living Facilities
- ClinicalTrials.gov ID
- NCT05211973
- Acronym / sponsor ID
- GAS2 / H-42048
- Keywords
- Healthy, Wearable Devices, Geriatric Anorexia, Frail
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Study start
- 28 Mar 2022 (actual)
- Primary completion
- 7 Sep 2022 (actual)
- Study completion
- 7 Sep 2022 (actual)
- First posted
- 27 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 compare feasibility of body weight, body fat, body composition and activity assessments in elderly subjects in long-term care (LTC), nursing home, or assisted living facilities. This will be accomplished through the use of questionnaires in addition to devices that evaluate movement, body composition, and body weight.
Detailed description
The overall aim of this study is to compare feasibility of body weight, body fat, body composition and activity assessments in elderly subjects in long-term care (LTC), nursing home, or assisted living facilities. This will be accomplished through the use of questionnaires in addition to devices that evaluate movement, body composition, and body weight.
The proposed study will consist of an initial intake visit on Day 1, followed by an at-home (i.e. LTC facility, nursing home, and/or assisted living facility) phase where the participant will wear two watch like devices one on each wrist and answer two questions on paper each day. There will be a second visit on day 8 where the participant will complete additional questionnaires and assessments. The participant will continue wearing the wrist-worn devices for days 9-14, with a final visit on day 15 for final assessments and device collection. A window of +/- 3 days will be allocated for the scheduling of all visits to accommodate participant's schedules and commitments. Activities will take place in the care facility where the participant resides, or the Laboratory for Human Neurobiology for those that will commute. The study procedures will be identical for all participants for all Frailty groups.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fried Frailty Phenotype 0 | – | Device: Wrist Actigraphy Device, Device: Smart Body Weight Scale, Device: Chair Scale, Device: Handheld Body Fat Percentage Device, Device: Bioelectric Impedance Analysis ScaleThose who are considered Robust under the Fried Frailty Criteria. Sensor technology and digital measures will be used to evaluate movement and body weight composition in healthy adults. |
| Fried Frailty Phenotype 1-2 | – | Device: Wrist Actigraphy Device, Device: Smart Body Weight Scale, Device: Chair Scale, Device: Handheld Body Fat Percentage Device, Device: Bioelectric Impedance Analysis ScaleThose who are considered Intermediate/Pre-frail under the Fried Frailty Criteria. Sensor technology and digital measures will be used to evaluate movement and body weight composition in healthy adults. |
| Fried Frailty Phenotype 3+ | – | Device: Wrist Actigraphy Device, Device: Smart Body Weight Scale, Device: Chair Scale, Device: Handheld Body Fat Percentage Device, Device: Bioelectric Impedance Analysis ScaleThose who are considered Frail under the Fried Frailty Criteria. Sensor technology and digital measures will be used to evaluate movement and body weight composition in healthy adults. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Healthy Adults
Key inclusion criteria (0 listed)
Key exclusion criteria (10 listed)
- Treatment with an investigational drug within 30 days of enrollment
- Moderate to severe alcohol use disorder diagnosis within 6 months of the screening as disclosed by the subject
- Participants who are investigational site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or participants who are Boston University/Boston Medical Center (BU/BMC) employees directly involved in the conduct of the study
- Inability to comply with study requirements
- Life expectancy of less than 6 months, or actively enrolled in a palliative care program
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wrist Actigraphy DeviceAlso: Geneactiv Watcha watch like wearable sensor | Device | Fried Frailty Phenotype 0, Fried Frailty Phenotype 1-2, Fried Frailty Phenotype 3+ |
| Smart Body Weight ScaleAlso: Renphoa full body composition scale that provides fat and muscle mass, water retention, bone mass, and weight trends (conducted based on participant's abilities) | Device | Fried Frailty Phenotype 0, Fried Frailty Phenotype 1-2, Fried Frailty Phenotype 3+ |
| Chair ScaleAlso: Meilestonea wheel-chair compatible scale to measure body weight | Device | Fried Frailty Phenotype 0, Fried Frailty Phenotype 1-2, Fried Frailty Phenotype 3+ |
| Handheld Body Fat Percentage DeviceAlso: Omrona handheld device that measures body fat percentage | Device | Fried Frailty Phenotype 0, Fried Frailty Phenotype 1-2, Fried Frailty Phenotype 3+ |
| Bioelectric Impedance Analysis ScaleAlso: Tanitaa research-grade full body composition scale that provides fat and muscle mass, water retention, bone mass, and weight trends (conducted based on participant's abilities) | Device | Fried Frailty Phenotype 0, Fried Frailty Phenotype 1-2, Fried Frailty Phenotype 3+ |
Primary outcome
Assess the use of accelerometry in an elderly cohort based in a LTC/nursing home/assisted-living setting
Time frame: 2 weeks +/- 3 days
Two GENEActiv watches will be used (one on each wrist) at a sampling rate of 50 Hz to measure movement in the x, y, and z direction across the study period.
Assess the use of a smart standing scale for body weight and composition assessment in an elderly cohort based in a LTC/nursing home/assisted-living setting (based on participant's abilities).
Time frame: 2 weeks +/- 3 days
A body weight composition scale will be used to completion of daily weight measurement and track body weight in kilograms (kg) throughout the study (based on participant's abilities).
Assess the use of a chair scale for body weight assessment in an elderly cohort based in a LTC/nursing home/assisted-living setting.
Time frame: 2 weeks +/- 3 days
A chair scale will be used during study staff visits to measure and track body weight.
Assess the use of a handheld body fat assessment tool for body fat percentage assessment in an elderly cohort based in a LTC/nursing home/assisted-living setting.
Time frame: 2 weeks +/- 3 days
A handheld body fat assessment tool will be used during study staff visits to measure body fat percentage.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2022.
- Derived from this study: PubMed 41860332Camerlingo N, Wicker M, Psaltos DJ, Shaafi-Kabiri N, Zhang H, Messere A, Messina I, Hayden Z, Kelly M, Kamat G, Karahanoglu FI, Demanuele C, Santamaria M, Caouette D, Thomas KC. Leveraging Digital Health Technologies to Assess Older Adults' Frailty and Nutritional Status: Two Cross-Sectional Studies. JMIR Aging. 2026 Apr 17;9:e77816. doi: 10.2196/77816.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin C Thomas, PhD, MBA principal investigator
Principal Investigator, Boston University, Department of Anatomy & Neurobiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy and Frailty, run by Boston University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the use of accelerometry in an elderly cohort based in a LTC/nursing home/assisted-living setting (time frame: 2 weeks +/- 3 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05211973, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2022.