Geriatric Anorexia Study

NCT04858932 | Completed

• 1 other identifier: H-40837
• Study Type: observational
• Target: 51
• 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 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.

Conditions

Healthy

Keywords

Healthy; Wearable Devices; Geriatric Anorexia

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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.

  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.

  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.

  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.

  21 days +/-4 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, metabolism, body weight composition, glucose levels, and nutritional scale in healthy adults.

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.

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.

Device: Continuous Glucose Monitor; Device: Wrist Actigraphy Device; Device: Food Weight Scale; Device: Smart Body Weight Scale

Interventions

Continuous Glucose Monitor DEVICE

a handheld reader and a wearable sensor placed on the back of the arm used to obtain glucose measurements

Also known as: Freestyle Libre

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

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+

Food Weight Scale DEVICE

a scale to measure food weight

Also known as: Renpho

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

Also known as: Renpho

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

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy adults

You may qualify if:

• \[separated into the three groups based on the Fried Criteria: 0, 1-2, 3 or above\]
• 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
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston University: lead

Study Sites (1)

Evans Biomedical Research Center

Boston, Massachusetts, 02118, United States

Location

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: April 14, 2021
• First Posted: April 26, 2021
• Study Start: April 27, 2021
• Primary Completion: December 15, 2021
• Study Completion: December 15, 2021
• Last Updated: February 1, 2022

Record last verified: 2022-01

Locations

US (1)