Behavioral Activation, Nutrition, and Activity Intervention

Not Applicable

Active, not recruiting

• Conditions: HIV
• Interventions: Behavioral: Physical Activity Coaching; Behavioral: Social Connection; Behavioral: Nutritional Coaching

• Registration Number: NCT06239961
• Lead Sponsor: University of Maryland, Baltimore

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2023-12-06
• Study First Submitted QC: 2024-01-25
• Study First Posted: 2024-02-02
• Study Start: 2024-09-23
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-28
• Last Update Posted: 2025-05-01
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Physical Activity Coaching	Physical Activity Coaching	The intervention involves physical activity sessions tailored for people with HIV. Participants engage in physical activities targeting health improvement and fall prevention, promoting physical activity self-efficacy and outcome expectations. Coaches identify individual exercise goals, assess access to physical activity options, and focus on safe, unsupervised strength and balance physical activities at home. Tailored exercise materials, including handouts and videos, are accessible through a website. Additionally, participants are encouraged to follow a structured walking program.
Behavioral Activation	Social Connection	Participants receive brief BA (Behavioral Activation) coaching through remote interactions (phone or videoconference) with lay coaches. The structured behavioral approach focuses on identifying and scheduling values-based, rewarding social engagements and activities. Coaches assist in overcoming barriers to social connectedness, involving a review of daily activity patterns, setting activity goals, creating implementation plans, and assessing successes and areas for improvement. The program is adapted for individuals aging with HIV, with community collaboration to tailor content and delivery methods.
Nutritional Assessment	Nutritional Coaching	Participants will complete a mini nutritional assessment and keep a food diary. Each participant will meet with a registered dietician for an evaluation. The coaching will be personalized based on the dietician's advice and will include information about community resources for food, making sure health options are available, and suggesting diets and recipes for better eating options.

Primary Outcome Measures

Name	Time	Method
Loneliness	Baseline and Week 16	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.
Total Sleep Time (TST) with Actigraphy	Baseline and Week 16	TST will be measured by a wearable sensor, from baseline to the final week of the intervention.
Nutritional Intake	Baseline	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.
Physical Activity (actigraphy) steps	Baseline and Week 16	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.
Depression	Baseline and Week 16	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.
Sleep Efficiency (SE) with Actigraphy	Baseline and Week 16	SE will be measured by a wearable sensor, from baseline to the final week of the intervention.
Sleep Onset Latency (SOL) with Actigraphy	Baseline and Week 16	SOL will be measured by a wearable sensor, from baseline to the final week of the intervention.
Social Isolation	Baseline and Week 16	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.
Physical Activity (actigraphy) sedentary time	Baseline and Week 16	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.

Secondary Outcome Measures

Name	Time	Method
Race	Baseline	Self reported racial or ethnic background.
Education	Baseline	Self reported completed level of schooling or degree obtained.
CD4 count	Baseline	A lab measurement of immune function in patients living with HIV.
Age	Baseline	Self reported chronological date of birth.
Generalized Anxiety Disorder 7	Baseline and Week 16	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.
Engagement in activities	Baseline and Week 16	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.
Reece 9-item HIV-related Stigma Scale	Baseline and Week 16	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.
Sexual preference	Baseline	Participants self reported sexual orientation.
Aspirin usage	Baseline	Assessing whether participants are using aspirin.
ASCVD Risk Score	Baseline	10-year risk calculated using the cardiovascular disease risk measures listed to help decide Statin or Aspirin prescription.
Gender at birth	Baseline	Characterization of male or female based on their biological characteristics when they were born.
Bone Mineral Density (BMD)	Baseline	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".
Late Life Function and Disability Instrument	Baseline and Week 16	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).
Gender identity now	Baseline	Characterization of male or female based on their self-identified gender.
Smoking Status	Baseline	Participants self reported smoking usage.
Blood pressure	Baseline	Measurement of the force of blood against the arterial walls, to evaluate the impact of interventions on cardiovascular health.
Lipids (Total cholesterol, Low-density lipoprotein (LDL), High-density lipoprotein (HDL), Triglycerides (TG))	Baseline	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.
Statin usage	Baseline	Assessing whether participants are using statin medications.
HIV viral load	Baseline	Viral load is a marker of response to antiretroviral therapy (ART).
Diabetes status	Baseline	Assessing participants for the presence or absence of diabetes.
Urine Albumin	Baseline	Urine analysis detects protein and blood in urine, supposed to be filtered by kidney, where Abnormal = "Risk for renal disease"; \>30 = "Kidney disease".
Glomerular Filtration Rate	Baseline	Measures kidney performance based on the amount of blood filtered per minute. Abnormal = "Risk for renal disease"; \<60 = "Kidney disease"; \<=15 = "Kidney failure".

Trial Locations

Locations (1)

University of Maryland, Baltimore; 🇺🇸 Baltimore, Maryland, United States