Behavioral Activation, Nutrition, and Activity Intervention

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

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.

Study Overview

• Status: Completed
• Conditions: HIV
• Intervention / Treatment: Behavioral: Physical Activity Coaching; Behavioral: Nutritional Coaching; Behavioral: Social Connection

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 Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland, Baltimore

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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: Physical Activity Coaching; 4 weekly physical activity coaching sessions with a 1 hour duration for each call.
Experimental: Nutritional Assessment; 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.	Behavioral: Nutritional Coaching; 4 weekly nutritional coaching calls with a Registered Dietician with a 1 hour duration for each call.
Experimental: Behavioral Activation; 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.	Behavioral: Social Connection; 6 weekly Behavioral Activation Intervention calls with a 1 hour duration for each call.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
Age	Self reported chronological date of birth.	Baseline
Race	Self reported racial or ethnic background.	Baseline
Gender at birth	Characterization of male or female based on their biological characteristics when they were born.	Baseline
Gender identity now	Characterization of male or female based on their self-identified gender.	Baseline
Sexual preference	Participants self reported sexual orientation.	Baseline
Education	Self reported completed level of schooling or degree obtained.	Baseline
CD4 count	A lab measurement of immune function in patients living with HIV.	Baseline
HIV viral load	Viral load is a marker of response to antiretroviral therapy (ART).	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".	Baseline
Smoking Status	Participants self reported smoking usage.	Baseline
Blood pressure	Measurement of the force of blood against the arterial walls, to evaluate the impact of interventions on cardiovascular health.	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.	Baseline
Diabetes status	Assessing participants for the presence or absence of diabetes.	Baseline
Aspirin usage	Assessing whether participants are using aspirin.	Baseline
Statin usage	Assessing whether participants are using statin medications.	Baseline
ASCVD Risk Score	10-year risk calculated using the cardiovascular disease risk measures listed to help decide Statin or Aspirin prescription.	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".	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".	Baseline

Collaborators and Investigators

• Sponsor: University of Maryland, Baltimore
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Ann Gruber-Baldini, PhD, UMB

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2024
• Primary Completion (Actual): June 19, 2025
• Study Completion (Actual): June 19, 2025

Study Registration Dates

• First Submitted: December 6, 2023
• First Submitted That Met QC Criteria: January 25, 2024
• First Posted (Actual): February 2, 2024

Study Record Updates

• Last Update Posted (Actual): July 4, 2025
• Last Update Submitted That Met QC Criteria: July 3, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: HIV; Nutrition; Physical activity; Aging; Social engagement
• Other Study ID Numbers: HP-00107100; 5P30AG028747-17 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Because a feasibility study, of 10 persons, the data could be identifiable.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No