This study will explore if a behavioral intervention program to assist people aged 50 and older with HIV is practical. The program includes a coach who talks with participants, encouraging them to be more active, reduce loneliness, and eat healthier.
This study aims to see if a 12-week program called Behavioral Activation (BA) can help people aged 50 and above with HIV by reducing loneliness and boosting social engagement. The program includes physical activity and nutrition guidance and is led by remote coaches. Investigators will recruit participants from the University of Maryland THRIVE program and other HIV centers in Baltimore. Investigators will test the program with 10 people aged 50 and above with HIV to see if it works. If it proves to be helpful and accepted, investigators might move on to a larger study to evaluate it more thoroughly.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
7
6 weekly Behavioral Activation Intervention calls with a 1 hour duration for each call.
4 weekly nutritional coaching calls with a Registered Dietician with a 1 hour duration for each call.
4 weekly physical activity coaching sessions with a 1 hour duration for each call.
University of Maryland, Baltimore
Baltimore, Maryland, United States
Depression
Participants will complete the Patient Health Questionnaire - 9 (PHQ-9) at baseline and at the Week 16 follow up visit. The nine items of the PHQ-9 are based directly on the nine diagnostic criteria for major depressive disorder in the DSM-IV. Where total scores of 5 to 9 = mild, 10 to 14 = moderate, 15 to 19 = moderately severe, and 20 = severe depression.
Time frame: Baseline and Week 16
Loneliness
Participants will complete the University of California, Los Angeles (UCLA) Loneliness Questionnaire (Version 3) at baseline and at the Week 16 follow up visit. This is a 20-item scale designed to measure one's subjective feelings of loneliness. Participants rate each item on a scale where 1 = Never, 2 = rarely, 3 = sometimes and 4 = Often. Total scores of 20 - 40 are considered low to moderate, 40 - 60 are considered moderate to high, and score above 60 are considered high in terms of loneliness.
Time frame: Baseline and Week 16
Social Isolation
Participants will complete the Patient-Reported Outcomes Measurement Information System (PROMIS) Social Isolation Scale at Baseline and at the Week 16 follow up visit, to measure social isolation. Total scores of 0.5 - 1.0 SD (standard deviation) worse than the mean = mild symptoms/impairment, scores of 1.0 - 2.0 SD worse than the mean = moderate symptoms/impairment, and scores 2.0 SD or more worse than the mean = severe symptoms/impairment.
Time frame: Baseline and Week 16
Physical Activity (actigraphy) steps
Participants will be given a wearable sensor device to track movements. Physical activity will be assessed using number of daily steps walked measured by the wearable sensor.
Time frame: Baseline and Week 16
Physical Activity (actigraphy) sedentary time
Participants will be given a wearable sensor device to track movements. Physical inactivity will be assessed using minutes of sedentary time measured by a wearable sensor.
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Time frame: Baseline and Week 16
Total Sleep Time (TST) with Actigraphy
TST will be measured by a wearable sensor, from baseline to the final week of the intervention.
Time frame: Baseline and Week 16
Sleep Efficiency (SE) with Actigraphy
SE will be measured by a wearable sensor, from baseline to the final week of the intervention.
Time frame: Baseline and Week 16
Sleep Onset Latency (SOL) with Actigraphy
SOL will be measured by a wearable sensor, from baseline to the final week of the intervention.
Time frame: Baseline and Week 16
Nutritional Intake
Participants will complete the 18-item Mini Nutritional Assessment (MNA®) at the baseline visit. The MNA® is a screening tool to help identify elderly persons who are malnourished or at risk of malnutrition. A score of 12 or greater indicates the person is well nourished and needs no further intervention. A score of 8-11 indicates the person is at risk of malnutrition. A score of 7 or less indicates the person is malnourished.
Time frame: Baseline
Generalized Anxiety Disorder 7
Participants will complete the Generalized Anxiety Disorder scale-7 (GAD-7) at the baseline and week 16 follow up visit. It is a seven-item diagnostic tool, based on the Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) criteria, for identifying likely cases of GAD. Where a score of 0 - 4 = minimal anxiety, 5 - 9 = mild anxiety, 10 - 14 = moderate anxiety, and a score greater than 15 = severe anxiety.
Time frame: Baseline and Week 16
Late Life Function and Disability Instrument
Participants will complete the Late-Life Function \& Disability Instrument (Late-Life FDI). It is designed to assess and be responsive to meaningful change in two distinct outcomes: function and disability. Scores approaching 100 signify high levels in ability to perform discrete actions and activities (without assistance), scores approaching 0 signify low levels in ability to perform discrete actions and activities (without assistance).
Time frame: Baseline and Week 16
Engagement in activities
Participants will complete the Yale Physical Activity Survey. This survey was developed to determine the type, amount and patterning of physical activity/exercise in older adults. The tool is composed of two sections - (1) amount of physical activity/exercise performed during a typical week in the past month and (2) activities performed in the past month. In section one, participants are handed a checklist of activity categories (work, exercise, and recreational activities) and are asked how often during the past week they performed a particular activity from each category. Higher scores indicate high levels of physical activity, while lower score indicate lower activity levels or more sedentary lifestyle.
Time frame: Baseline and Week 16
Reece 9-item HIV-related Stigma Scale
A 9-item instrument with possible scores ranging from 0 (no perceived stigma) to 45 (high perceived stigma). The HIV Stigma Scale was designed to measure the perception of stigma by those who are HIV infected.
Time frame: Baseline and Week 16
Age
Self reported chronological date of birth.
Time frame: Baseline
Race
Self reported racial or ethnic background.
Time frame: Baseline
Gender at birth
Characterization of male or female based on their biological characteristics when they were born.
Time frame: Baseline
Gender identity now
Characterization of male or female based on their self-identified gender.
Time frame: Baseline
Sexual preference
Participants self reported sexual orientation.
Time frame: Baseline
Education
Self reported completed level of schooling or degree obtained.
Time frame: Baseline
CD4 count
A lab measurement of immune function in patients living with HIV.
Time frame: Baseline
HIV viral load
Viral load is a marker of response to antiretroviral therapy (ART).
Time frame: Baseline
Bone Mineral Density (BMD)
BMD is expressed by the mass of calcium hydroxyapatite present in a given area or volume of bone in a unit of mass/area (g/cm2) or mass/volume (g/cm3), respectively. "-2.5 and below" = "Osteoporosis" " -1.1 to -2.5" = "Osteopenia".
Time frame: Baseline
Smoking Status
Participants self reported smoking usage.
Time frame: Baseline
Blood pressure
Measurement of the force of blood against the arterial walls, to evaluate the impact of interventions on cardiovascular health.
Time frame: Baseline
Lipids (Total cholesterol, Low-density lipoprotein (LDL), High-density lipoprotein (HDL), Triglycerides (TG))
Lipid panel measures all three cholesterol and triglyceride/fat in the blood to assess for CVD risk. \>240 mg/dl = High total cholesterol; 130 - 159 md/dl = High LDL; \<40 mg/dl = Low HDL; \>150 mg/dl = High TG.
Time frame: Baseline
Diabetes status
Assessing participants for the presence or absence of diabetes.
Time frame: Baseline
Aspirin usage
Assessing whether participants are using aspirin.
Time frame: Baseline
Statin usage
Assessing whether participants are using statin medications.
Time frame: Baseline
ASCVD Risk Score
10-year risk calculated using the cardiovascular disease risk measures listed to help decide Statin or Aspirin prescription.
Time frame: Baseline
Urine Albumin
Urine analysis detects protein and blood in urine, supposed to be filtered by kidney, where Abnormal = "Risk for renal disease"; \>30 = "Kidney disease".
Time frame: Baseline
Glomerular Filtration Rate
Measures kidney performance based on the amount of blood filtered per minute. Abnormal = "Risk for renal disease"; \<60 = "Kidney disease"; \<=15 = "Kidney failure".
Time frame: Baseline