HIVNCT06239961
Behavioral Activation, Nutrition, and Activity Intervention
A study testing Social Connection, Nutritional Coaching and Physical Activity Coaching in people with HIV, run by University of Maryland, Baltimore at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- HIV
- What is being tested?
- Social Connection, Nutritional Coaching and Physical Activity Coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Sep 2024to 19 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 50 years of age or older
- HIV positive diagnosis
- Montreal Cognitive Assessment score > 13
- Report minimal level of loneliness, isolation, and/or depression (PHQ9 > 5)
- Able to consent
- Ability to read or speak English
- Attend the UM THRIVE Center or another HIV center in Baltimore
Who cannot join
- 1) No severe cognitive impairment
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland, Baltimore
Baltimore, Maryland, 21201
About this study
Official title: 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.
Read the 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.
- Conditions
- HIV
- Being tested
- Social Connection, Nutritional Coaching, Physical Activity Coaching
- Keywords
- Aging, HIV, Social engagement, Nutrition, Physical activity
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social ConnectionBehavioural
6 weekly Behavioral Activation Intervention calls with a 1 hour duration for each call.
Nutritional CoachingBehavioural
4 weekly nutritional coaching calls with a Registered Dietician with a 1 hour duration for each call.
Physical Activity CoachingBehavioural
4 weekly physical activity coaching sessions with a 1 hour duration for each call.
| Study group | Role | What they receive |
|---|---|---|
| Physical Activity Coaching | Experimental | 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. Receives: Behavioral: Physical Activity Coaching |
| Nutritional Assessment | Experimental | 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. Receives: Behavioral: Nutritional Coaching |
| Behavioral Activation | Experimental | 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. Receives: Behavioral: Social Connection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline
Secondary outcomes (22)
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Baseline and Week 16
Age
Self reported chronological date of birth.
Measured: Baseline
Race
Self reported racial or ethnic background.
Measured: Baseline
Gender at birth
Characterization of male or female based on their biological characteristics when they were born.
Measured: Baseline
Gender identity now
Characterization of male or female based on their self-identified gender.
Measured: Baseline
Sexual preference
Participants self reported sexual orientation.
Measured: Baseline
Education
Self reported completed level of schooling or degree obtained.
Measured: Baseline
CD4 count
A lab measurement of immune function in patients living with HIV.
Measured: Baseline
HIV viral load
Viral load is a marker of response to antiretroviral therapy (ART).
Measured: 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".
Measured: Baseline
Smoking Status
Participants self reported smoking usage.
Measured: Baseline
Blood pressure
Measurement of the force of blood against the arterial walls, to evaluate the impact of interventions on cardiovascular health.
Measured: 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.
Measured: Baseline
Diabetes status
Assessing participants for the presence or absence of diabetes.
Measured: Baseline
Aspirin usage
Assessing whether participants are using aspirin.
Measured: Baseline
Statin usage
Assessing whether participants are using statin medications.
Measured: Baseline
ASCVD Risk Score
10-year risk calculated using the cardiovascular disease risk measures listed to help decide Statin or Aspirin prescription.
Measured: 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".
Measured: 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".
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2024
- Study start23 Sep 2024
- Primary completion19 Jun 2025
- Study completion19 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- The Brief Behavioral Activation (BA) Coaching will involve having lay coaches work with participants remotely (i.e., by phone or videoconference) to identify and schedule values-based, rewarding social engagement and activities and to use strategies to reduce and problem-solve barriers to social connectedness. Participants first review their daily activity patterns, and then chose activity goals, worked on specific implementation plans, and reviewed their successes and areas for improvement. The behavioral activation coach program will be modified to address the needs of people aging with HIV (PAWH) by working with those in the community to tailor the content and mode of delivery. There will be additional modules on physical activity and nutrition.
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Ann Gruber-Baldini, University of Maryland, Baltimore
- Investigators
- Ann Gruber-Baldini, PhD, Principal investigator, UMB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06239961
- Sponsor's protocol ID
- HP-00107100
- Other IDs
- 5P30AG028747-17
- Status last verified
- Jul 2025
- First submitted
- 6 Dec 2023
- Last updated
- 4 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Because a feasibility study, of 10 persons, the data could be identifiable.
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Component Behavioral Activation, Nutrition, and Activity Intervention for Persons Aging With HIV
- ClinicalTrials.gov ID
- NCT06239961
- Acronym / sponsor ID
- HP-00107100
- Conditions
- HIV
- Keywords
- Aging, HIV, Social engagement, Nutrition, Physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 23 Sep 2024 (actual)
- Primary completion
- 19 Jun 2025 (actual)
- Study completion
- 19 Jun 2025 (actual)
- First posted
- 2 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The Brief Behavioral Activation (BA) Coaching will involve having lay coaches work with participants remotely (i.e., by phone or videoconference) to identify and schedule values-based, rewarding social engagement and activities and to use strategies to reduce and problem-solve barriers to social connectedness. Participants first review their daily activity patterns, and then chose activity goals, worked on specific implementation plans, and reviewed their successes and areas for improvement. The behavioral activation coach program will be modified to address the needs of people aging with HIV (PAWH) by working with those in the community to tailor the content and mode of delivery. There will be additional modules on physical activity and nutrition.
| Arm | Type | Receives |
|---|---|---|
| Physical Activity Coaching | Experimental | Behavioral: Physical Activity CoachingThe 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. |
| Nutritional Assessment | Experimental | Behavioral: Nutritional CoachingParticipants 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 Activation | Experimental | Behavioral: Social ConnectionParticipants 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 50 years of age or older
- HIV positive diagnosis
- Montreal Cognitive Assessment score > 13
- Report minimal level of loneliness, isolation, and/or depression (PHQ9 > 5)
- Able to consent
Key exclusion criteria (1 listed)
- 1) No severe cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Social Connection6 weekly Behavioral Activation Intervention calls with a 1 hour duration for each call. | Behavioural | Behavioral Activation |
| Nutritional Coaching4 weekly nutritional coaching calls with a Registered Dietician with a 1 hour duration for each call. | Behavioural | Nutritional Assessment |
| Physical Activity Coaching4 weekly physical activity coaching sessions with a 1 hour duration for each call. | Behavioural | Physical Activity Coaching |
Primary outcome
Depression
Time frame: 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.
Loneliness
Time frame: 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.
Social Isolation
Time frame: 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) steps
Time frame: 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.
Physical Activity (actigraphy) sedentary time
Time frame: 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.
Total Sleep Time (TST) with Actigraphy
Time frame: Baseline and Week 16
TST will be measured by a wearable sensor, from baseline to the final week of the intervention.
Sleep Efficiency (SE) with Actigraphy
Time frame: 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
Time frame: Baseline and Week 16
SOL will be measured by a wearable sensor, from baseline to the final week of the intervention.
Nutritional Intake
Time frame: 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.
22 secondary outcomes
Generalized Anxiety Disorder 7
Time frame: Baseline and Week 16
Late Life Function and Disability Instrument
Time frame: Baseline and Week 16
Engagement in activities
Time frame: Baseline and Week 16
Reece 9-item HIV-related Stigma Scale
Time frame: Baseline and Week 16
Age
Time frame: Baseline
Race
Time frame: Baseline
Gender at birth
Time frame: Baseline
Gender identity now
Time frame: Baseline
Sexual preference
Time frame: Baseline
Education
Time frame: Baseline
CD4 count
Time frame: Baseline
HIV viral load
Time frame: Baseline
Bone Mineral Density (BMD)
Time frame: Baseline
Smoking Status
Time frame: Baseline
Blood pressure
Time frame: Baseline
Lipids (Total cholesterol, Low-density lipoprotein (LDL), High-density lipoprotein (HDL), Triglycerides (TG))
Time frame: Baseline
Diabetes status
Time frame: Baseline
Aspirin usage
Time frame: Baseline
Statin usage
Time frame: Baseline
ASCVD Risk Score
Time frame: Baseline
Urine Albumin
Time frame: Baseline
Glomerular Filtration Rate
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2025.
- Individual participant dataSharing planned: No. Because a feasibility study, of 10 persons, the data could be identifiable.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ann Gruber-Baldini, PhD principal investigator
UMB
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Social Connection, Nutritional Coaching and Physical Activity Coaching in people with HIV, run by University of Maryland, Baltimore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression (time frame: Baseline and Week 16). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jul 2025.