HealthyGASNCT04858932
Geriatric Anorexia Study
An observational study of Healthy, 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 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Continuous Glucose Monitor, Wrist Actigraphy Device and Food Weight Scale
- Type of treatment
- Medical device
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Apr 2021to 15 Dec 2021
- 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 to 85 years
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Healthy adults
Who may be able to join
- [separated into the three groups based on the Fried Criteria: 0, 1-2, 3 or above]
- Male or female participants aged 65 - 85 years.
- No clinically significant health problems other than well controlled chronic conditions (e.g., allergies and dermatitis)
- No recent hospitalizations/acute events in last 12 months.
- No active or recent (within 12 months) cancer diagnosis except skin cancer (limited to only non-complicated Squamous Cell Carcinoma (SCC)/Basal Cell Carcinoma (BCC)).
- Body mass index (BMI) < 30 kg/m2
Show all 11Show fewer
- Able to understand and cooperate with study procedures and able to read, understand and provide informed consent. Evidence of a personally signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study
- Participants should not have any food aversion which could influence their food selection if standardized meals are used as part of the protocol.
- Native English speakers or demonstrated fluency in English as determined by the Investigator.
- Wide Range Achievement Test (WRAT-4) Word Reading Subtest equivalent to 8th grade reading level or greater.
- Normal or corrected-to-normal vision
Who cannot join
- Treatment with an investigational drug within 30 days of enrollment
- A moderate to severe alcohol use disorder diagnosis within 6 months of the screening as disclosed by the subject
- Subjects 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 subjects who are Boston University/Boston Medical Center directly involved in the conduct of the study
- Inability to comply with study requirements.
- Has any clinically significant medical disorder, condition, disease or clinically significant finding at screening that precludes subject's participation in study activities including any self-reported diagnosis of eating disorders.
- Participants with electronic implant devices, such as pacemaker.
- Non-English Reader as measured by the WRAT-4.
Trial locations and contacts
1 site in 1 country.
United States1 site
Evans Biomedical Research Center
Boston, Massachusetts, 02118
About this study
Official title: Novel Digital Endpoints in Geriatric Anorexia
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.
Read the 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
- Healthy
- Being tested
- Continuous Glucose Monitor, Wrist Actigraphy Device, Food Weight Scale, Smart Body Weight Scale
- Keywords
- Healthy, Wearable Devices, Geriatric Anorexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Glucose MonitorDevice
Also called Freestyle Libre
a handheld reader and a wearable sensor placed on the back of the arm used to obtain glucose measurements
Wrist Actigraphy DeviceDevice
Also called Geneactiv Watch
a watch like wearable sensor
Food Weight ScaleDevice
Also called Renpho
a scale to measure food weight
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
| 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, metabolism, body weight composition, glucose levels, and nutritional scale in healthy adults. Receives: Device: Continuous Glucose Monitor; Device: Wrist Actigraphy Device; Device: Food Weight Scale; Device: Smart Body Weight 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, metabolism, body weight composition, glucose levels, and nutritional scale in healthy adults. Receives: Device: Continuous Glucose Monitor; Device: Wrist Actigraphy Device; Device: Food Weight Scale; Device: Smart Body Weight 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, metabolism, body weight composition, glucose levels, and nutritional scale in healthy adults. Receives: Device: Continuous Glucose Monitor; Device: Wrist Actigraphy Device; Device: Food Weight Scale; Device: Smart Body Weight Scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the feasibility, usability, and compliance of wearing a GENEActiv watch in a geriatric population both in-clinic and remotely at-home.
One GENEActiv watch will be used on one wrist and one around the waist at a sampling rate of 50 Hz to measure movement in the x, y, and z direction across the study period.
Measured: 21 days +/- 4 days
Assess the feasibility, usability, and compliance of food consumption tracking in a geriatric population both in-clinic and remotely at-home.
A food scale will be used to track food consumed in grams (g) throughout the study. The total number of meals consumed per day and across study period.
Measured: 21 days +/- 4 days
Assess the feasibility, usability, and compliance of body weight composition measurements in a geriatric population both in-clinic and remotely at-home.
A body weight composition scale will be used to completion of daily weight measurement and track body weight in kilograms (kg) throughout the study.
Measured: 21 days +/- 4 days
Assess the correlation of a GENEActiv watch with frailty phenotype in elderly participants.
One GENEActiv watch will be used on one wrist and one around the waist at a sampling rate of 50 Hz to measure movement in the x, y, and z direction. This data will be compared to frailty phenotype per the Fried Frailty Scale and continuous glucose measurements.
Measured: 21 days +/- 4 days
Assess the correlation of food consumption with frailty phenotype in elderly participants.
A food scale will be used to track food consumed in grams (g) throughout the study. This data will be compared to frailty phenotype per the Fried Frailty Scale.
Measured: 21 days +/-4 days
Assess the correlation of the body weight composition scale with frailty phenotype in elderly participants.
A body weight composition scale will be used to track body weight in kilograms (kg) throughout the study. This data will be compared to frailty phenotype per the Fried Frailty Scale.
Measured: 21 days +/-4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2021
- Study start27 Apr 2021
- Primary completion15 Dec 2021
- Study completion15 Dec 2021
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
- 51 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
- NCT04858932
- Sponsor's protocol ID
- H-40837
- Acronym
- GAS
- Status last verified
- Jan 2022
- First submitted
- 14 Apr 2021
- Last updated
- 1 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 1 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Digital Endpoints in Geriatric Anorexia
- ClinicalTrials.gov ID
- NCT04858932
- Acronym / sponsor ID
- GAS / H-40837
- Conditions
- Healthy
- Keywords
- Healthy, Wearable Devices, Geriatric Anorexia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Study start
- 27 Apr 2021 (actual)
- Primary completion
- 15 Dec 2021 (actual)
- Study completion
- 15 Dec 2021 (actual)
- First posted
- 26 Apr 2021 (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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fried Frailty Phenotype 0 | – | Device: Continuous Glucose Monitor, Device: Wrist Actigraphy Device, Device: Food Weight Scale, Device: Smart Body Weight ScaleThose who are considered Robust under the Fried Frailty Criteria. Sensor technology and digital measures will be used to evaluate movement, metabolism, body weight composition, glucose levels, and nutritional scale in healthy adults. |
| Fried Frailty Phenotype 1-2 | – | Device: Continuous Glucose Monitor, Device: Wrist Actigraphy Device, Device: Food Weight Scale, Device: Smart Body Weight ScaleThose who are considered Intermediate/Pre-frail under the Fried Frailty Criteria. Sensor technology and digital measures will be used to evaluate movement, metabolism, body weight composition, glucose levels, and nutritional scale in healthy adults. |
| Fried Frailty Phenotype 3+ | – | Device: Continuous Glucose Monitor, Device: Wrist Actigraphy Device, Device: Food Weight Scale, Device: Smart Body Weight ScaleThose who are considered Frail under the Fried Frailty Criteria. Sensor technology and digital measures will be used to evaluate movement, metabolism, body weight composition, glucose levels, and nutritional scale in healthy adults. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Healthy adults
Key inclusion criteria (11 listed)
- [separated into the three groups based on the Fried Criteria: 0, 1-2, 3 or above]
- Male or female participants aged 65 - 85 years.
- No clinically significant health problems other than well controlled chronic conditions (e.g., allergies and dermatitis)
- No recent hospitalizations/acute events in last 12 months.
- No active or recent (within 12 months) cancer diagnosis except skin cancer (limited to only non-complicated Squamous Cell Carcinoma (SCC)/Basal Cell Carcinoma (BCC)).
Key exclusion criteria (7 listed)
- Treatment with an investigational drug within 30 days of enrollment
- A moderate to severe alcohol use disorder diagnosis within 6 months of the screening as disclosed by the subject
- Subjects 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 subjects who are Boston University/Boston Medical Center directly involved in the conduct of the study
- Inability to comply with study requirements.
- Has any clinically significant medical disorder, condition, disease or clinically significant finding at screening that precludes subject's participation in study activities including any self-reported diagnosis of eating disorders.
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 |
|---|---|---|
| Continuous Glucose MonitorAlso: Freestyle Librea handheld reader and a wearable sensor placed on the back of the arm used to obtain glucose measurements | Device | Fried Frailty Phenotype 0, Fried Frailty Phenotype 1-2, Fried Frailty Phenotype 3+ |
| Wrist Actigraphy DeviceAlso: Geneactiv Watcha watch like wearable sensor | Device | Fried Frailty Phenotype 0, Fried Frailty Phenotype 1-2, Fried Frailty Phenotype 3+ |
| Food Weight ScaleAlso: Renphoa scale to measure food weight | 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 | Device | Fried Frailty Phenotype 0, Fried Frailty Phenotype 1-2, Fried Frailty Phenotype 3+ |
Primary outcome
Assess the feasibility, usability, and compliance of wearing a GENEActiv watch in a geriatric population both in-clinic and remotely at-home.
Time frame: 21 days +/- 4 days
One GENEActiv watch will be used on one wrist and one around the waist at a sampling rate of 50 Hz to measure movement in the x, y, and z direction across the study period.
Assess the feasibility, usability, and compliance of food consumption tracking in a geriatric population both in-clinic and remotely at-home.
Time frame: 21 days +/- 4 days
A food scale will be used to track food consumed in grams (g) throughout the study. The total number of meals consumed per day and across study period.
Assess the feasibility, usability, and compliance of body weight composition measurements in a geriatric population both in-clinic and remotely at-home.
Time frame: 21 days +/- 4 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.
Assess the correlation of a GENEActiv watch with frailty phenotype in elderly participants.
Time frame: 21 days +/- 4 days
One GENEActiv watch will be used on one wrist and one around the waist at a sampling rate of 50 Hz to measure movement in the x, y, and z direction. This data will be compared to frailty phenotype per the Fried Frailty Scale and continuous glucose measurements.
Assess the correlation of food consumption with frailty phenotype in elderly participants.
Time frame: 21 days +/-4 days
A food scale will be used to track food consumed in grams (g) throughout the study. This data will be compared to frailty phenotype per the Fried Frailty Scale.
Assess the correlation of the body weight composition scale with frailty phenotype in elderly participants.
Time frame: 21 days +/-4 days
A body weight composition scale will be used to track body weight in kilograms (kg) throughout the study. This data will be compared to frailty phenotype per the Fried Frailty Scale.
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 1 Feb 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.
- Individual participant dataSharing planned: Undecided
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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, 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 11 inclusion and 7 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 1 Feb 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 feasibility, usability, and compliance of wearing a GENEActiv watch in a geriatric population both in-clinic and remotely at-home. (time frame: 21 days +/- 4 days). The study lists 6 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 NCT04858932, 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 1 Feb 2022.