Behavioral Activation, Nutrition, and Activity Intervention

HIV Clinical Trial

Official title:

Multi-Component Behavioral Activation, Nutrition, and Activity Intervention for Persons Aging With HIV

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06239961
• Other study ID #: HP-00107100
• Secondary ID: 5P30AG028747-17
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 6, 2024
• Est. completion date: May 30, 2026

Study information

• Verified date: May 2024
• Source: University of Maryland, Baltimore
• Contact: Ann Gruber-Baldini, PhD
• Phone: 410-706-2444
• Email: abaldin[@]som.umaryland.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: May 30, 2026
• Est. primary completion date: May 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

1. 50 years of age or older

2. HIV positive diagnosis

3. Montreal Cognitive Assessment score > 13

4. Report minimal level of loneliness, isolation, and/or depression (PHQ9 > 5)

5. Able to consent

6. Ability to read or speak English

7. Attend the UM THRIVE Center or another HIV center in Baltimore

Exclusion Criteria:

1) No severe cognitive impairment

Related Conditions & MeSH terms

• HIV

Intervention

Behavioral:
• Social Connection
6 weekly Behavioral Activation Intervention calls with a 1 hour duration for each call.
• Nutritional Coaching
4 weekly nutritional coaching calls with a Registered Dietician with a 1 hour duration for each call.
• Physical Activity Coaching
4 weekly physical activity coaching sessions with a 1 hour duration for each call.

Locations

Country	Name	City	State
United States	University of Maryland, Baltimore	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
University of Maryland, Baltimore	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline and Week 16
Primary	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.	Baseline and Week 16
Primary	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.	Baseline and Week 16
Primary	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.	Baseline and Week 16
Primary	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.	Baseline and Week 16
Primary	Total Sleep Time (TST) with Actigraphy	TST will be measured by a wearable sensor, from baseline to the final week of the intervention.	Baseline and Week 16
Primary	Sleep Efficiency (SE) with Actigraphy	SE will be measured by a wearable sensor, from baseline to the final week of the intervention.	Baseline and Week 16
Primary	Sleep Onset Latency (SOL) with Actigraphy	SOL will be measured by a wearable sensor, from baseline to the final week of the intervention.	Baseline and Week 16
Primary	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.	Baseline
Secondary	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.	Baseline and Week 16
Secondary	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).	Baseline and Week 16
Secondary	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.	Baseline and Week 16
Secondary	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.	Baseline and Week 16
Secondary	Age	Self reported chronological date of birth.	Baseline
Secondary	Race	Self reported racial or ethnic background.	Baseline
Secondary	Gender at birth	Characterization of male or female based on their biological characteristics when they were born.	Baseline
Secondary	Gender identity now	Characterization of male or female based on their self-identified gender.	Baseline
Secondary	Sexual preference	Participants self reported sexual orientation.	Baseline
Secondary	Education	Self reported completed level of schooling or degree obtained.	Baseline
Secondary	CD4 count	A lab measurement of immune function in patients living with HIV.	Baseline
Secondary	HIV viral load	Viral load is a marker of response to antiretroviral therapy (ART).	Baseline
Secondary	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".	Baseline
Secondary	Smoking Status	Participants self reported smoking usage.	Baseline
Secondary	Blood pressure	Measurement of the force of blood against the arterial walls, to evaluate the impact of interventions on cardiovascular health.	Baseline
Secondary	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.	Baseline
Secondary	Diabetes status	Assessing participants for the presence or absence of diabetes.	Baseline
Secondary	Aspirin usage	Assessing whether participants are using aspirin.	Baseline
Secondary	Statin usage	Assessing whether participants are using statin medications.	Baseline
Secondary	ASCVD Risk Score	10-year risk calculated using the cardiovascular disease risk measures listed to help decide Statin or Aspirin prescription.	Baseline
Secondary	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".	Baseline
Secondary	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".	Baseline