Geriatric Anorexia Study 2.0

NCT05211973 | Completed

• 1 other identifier: H-42048
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Healthy; Frailty

Keywords

Healthy; Wearable Devices; Geriatric Anorexia; Frail

Outcome Measures

Primary Outcomes (4)

• 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.

  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).

  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.

  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.

  2 weeks +/- 3 days

Study Arms (3)

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; 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.

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.

Device: Wrist Actigraphy Device; Device: Smart Body Weight Scale; Device: Chair Scale; Device: Handheld Body Fat Percentage Device; Device: Bioelectric Impedance Analysis Scale

Interventions

Wrist Actigraphy Device DEVICE

a watch like wearable sensor

Also known as: Geneactiv Watch

Fried Frailty Phenotype 0; Fried Frailty Phenotype 1-2; Fried Frailty Phenotype 3+

Smart Body Weight Scale DEVICE

a full body composition scale that provides fat and muscle mass, water retention, bone mass, and weight trends (conducted based on participant's abilities)

Also known as: Renpho

Fried Frailty Phenotype 0; Fried Frailty Phenotype 1-2; Fried Frailty Phenotype 3+

Chair Scale DEVICE

a wheel-chair compatible scale to measure body weight

Also known as: Meilestone

Fried Frailty Phenotype 0; Fried Frailty Phenotype 1-2; Fried Frailty Phenotype 3+

Handheld Body Fat Percentage Device DEVICE

a handheld device that measures body fat percentage

Also known as: Omron

Fried Frailty Phenotype 0; Fried Frailty Phenotype 1-2; Fried Frailty Phenotype 3+

Bioelectric Impedance Analysis Scale DEVICE

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)

Also known as: Tanita

Fried Frailty Phenotype 0; Fried Frailty Phenotype 1-2; Fried Frailty Phenotype 3+

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy Adults

You may qualify if:

• Male or female participants aged 65 years of age and over
• No recent hospitalizations/acute events in last 30 days
• No active or recent (within 12 months) cancer diagnosis except skin cancer \[limited to only non-complicated squamous and basal cell skin cancer (SCC/BCC)\]
• Body mass index (BMI) \< 30 kg/m2
• 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.
• Native English speakers or demonstrated fluency in English as determined by the Investigator
• WRAT-4 Word Reading Subtest equivalent to 8th grade reading level or greater
• Montreal Cognitive Assessment (MoCA) score of ≥ to 19

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Boston University: lead

Study Sites (1)

Evans Biomedical Research Center

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kevin C Thomas, PhD, MBA

  Principal Investigator, Boston University, Department of Anatomy & Neurobiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2022
• First Posted: January 27, 2022
• Study Start: March 28, 2022
• Primary Completion: September 7, 2022
• Study Completion: September 7, 2022
• Last Updated: September 28, 2022

Record last verified: 2022-09

Locations

US (1)