Geriatric Anorexia Study 2.0 (NCT05211973) | Clinical Trial Compass
CompletedNot Applicable
Geriatric Anorexia Study 2.0
United States44 participantsStarted 2022-03-28
Plain-language 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.
Who can participate
Age range
65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Assess the use of accelerometry in an elderly cohort based in a LTC/nursing home/assisted-living setting
Timeframe: 2 weeks +/- 3 days
2
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).
Timeframe: 2 weeks +/- 3 days
3
Assess the use of a chair scale for body weight assessment in an elderly cohort based in a LTC/nursing home/assisted-living setting.
Timeframe: 2 weeks +/- 3 days
4
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.
. WRAT-4 Word Reading Subtest equivalent to 8th grade reading level or greater
. Montreal Cognitive Assessment (MoCA) score of ≥ to 19
Exclusion criteria
. 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