Geriatric Anorexia Study 2.0 (GAS2)

September 26, 2022 updated by: Boston University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

44

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Evans Biomedical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Healthy Adults

Description

Inclusion Criteria: [separated into the three groups based on the Fried Criteria: 0 - robust, 1-2 - intermediate or pre-frail, 3 or above - frail; enrollment into individual frailty groups will close once the recruitment goal is reached for that group]

  1. Male or female participants aged 65 years of age and over
  2. No recent hospitalizations/acute events in last 30 days
  3. No active or recent (within 12 months) cancer diagnosis except skin cancer [limited to only non-complicated squamous and basal cell skin cancer (SCC/BCC)]
  4. Body mass index (BMI) < 30 kg/m2
  5. 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, if necessary, their legally authorized representative (LAR) has been informed of all pertinent aspects of the study.
  6. Native English speakers or demonstrated fluency in English as determined by the Investigator
  7. WRAT-4 Word Reading Subtest equivalent to 8th grade reading level or greater
  8. Montreal Cognitive Assessment (MoCA) score of ≥ to 19

Exclusion Criteria:

  1. Treatment with an investigational drug within 30 days of enrollment
  2. Moderate to severe alcohol use disorder diagnosis within 6 months of the screening as disclosed by the subject
  3. 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
  4. Inability to comply with study requirements
  5. Life expectancy of less than 6 months, or actively enrolled in a palliative care program
  6. Has any clinically significant medical disorder, condition, disease, or clinically significant finding at screening that precludes subject's participation in study activities
  7. 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
  8. At an increased risk of COVID-19 as determined by the Laboratory for Human Neurobiology COVID-19 Human Subject Risk Assessment Survey
  9. Temperature equal to or above 100.4 degrees F
  10. Modified Barthel Index of <40

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Device: Wrist Actigraphy Device
a watch like wearable sensor
Other Names:
  • Geneactiv Watch
Device: Smart Body Weight Scale
a full body composition scale that provides fat and muscle mass, water retention, bone mass, and weight trends (conducted based on participant's abilities)
Other Names:
  • Renpho
Device: Chair Scale
a wheel-chair compatible scale to measure body weight
Other Names:
  • Meilestone
Device: Handheld Body Fat Percentage Device
a handheld device that measures body fat percentage
Other Names:
  • Omron
Device: Bioelectric Impedance Analysis Scale
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)
Other Names:
  • Tanita
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.
Device: Wrist Actigraphy Device
a watch like wearable sensor
Other Names:
  • Geneactiv Watch
Device: Smart Body Weight Scale
a full body composition scale that provides fat and muscle mass, water retention, bone mass, and weight trends (conducted based on participant's abilities)
Other Names:
  • Renpho
Device: Chair Scale
a wheel-chair compatible scale to measure body weight
Other Names:
  • Meilestone
Device: Handheld Body Fat Percentage Device
a handheld device that measures body fat percentage
Other Names:
  • Omron
Device: Bioelectric Impedance Analysis Scale
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)
Other Names:
  • Tanita
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.
Device: Wrist Actigraphy Device
a watch like wearable sensor
Other Names:
  • Geneactiv Watch
Device: Smart Body Weight Scale
a full body composition scale that provides fat and muscle mass, water retention, bone mass, and weight trends (conducted based on participant's abilities)
Other Names:
  • Renpho
Device: Chair Scale
a wheel-chair compatible scale to measure body weight
Other Names:
  • Meilestone
Device: Handheld Body Fat Percentage Device
a handheld device that measures body fat percentage
Other Names:
  • Omron
Device: Bioelectric Impedance Analysis Scale
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)
Other Names:
  • Tanita

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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).
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).
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.
Time Frame: 2 weeks +/- 3 days
A chair scale will be used during study staff visits to measure and track body weight.
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.
Time Frame: 2 weeks +/- 3 days
A handheld body fat assessment tool will be used during study staff visits to measure body fat percentage.
2 weeks +/- 3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston University

Investigators

  • Principal Investigator: Kevin C Thomas, PhD, MBA, Principal Investigator, Boston University, Department of Anatomy & Neurobiology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 28, 2022

Primary Completion (Actual)

September 7, 2022

Study Completion (Actual)

September 7, 2022

Study Registration Dates

First Submitted

January 13, 2022

First Submitted That Met QC Criteria

January 25, 2022

First Posted (Actual)

January 27, 2022

Study Record Updates

Last Update Posted (Actual)

September 28, 2022

Last Update Submitted That Met QC Criteria

September 26, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-42048

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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