Clinical trial NCT06239961: Behavioral Activation, Nutrition, and Activity Intervention
Official title: Multi-Component Behavioral Activation, Nutrition, and Activity Intervention for Persons Aging With HIV
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: HIV
Keywords: Aging
HIV
Social engagement
Nutrition
Physical activity
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2024-02-02
Enrollment: 10
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Depression
timeFrame: Baseline and Week 16
measure: Loneliness
timeFrame: Baseline and Week 16
measure: Social Isolation
timeFrame: Baseline and Week 16
measure: Physical Activity (actigraphy) steps
timeFrame: Baseline and Week 16
measure: Physical Activity (actigraphy) sedentary time
timeFrame: Baseline and Week 16
measure: Total Sleep Time (TST) with Actigraphy
timeFrame: Baseline and Week 16
measure: Sleep Efficiency (SE) with Actigraphy
timeFrame: Baseline and Week 16
measure: Sleep Onset Latency (SOL) with Actigraphy
timeFrame: Baseline and Week 16
measure: Nutritional Intake
timeFrame: Baseline
Secondary outcomes:
measure: Generalized Anxiety Disorder 7
timeFrame: Baseline and Week 16
measure: Late Life Function and Disability Instrument
timeFrame: Baseline and Week 16
measure: Engagement in activities
timeFrame: Baseline and Week 16
measure: Reece 9-item HIV-related Stigma Scale
timeFrame: Baseline and Week 16
measure: Age
timeFrame: Baseline
measure: Race
timeFrame: Baseline
measure: Gender at birth
timeFrame: Baseline
measure: Gender identity now
timeFrame: Baseline
measure: Sexual preference
timeFrame: Baseline
measure: Education
timeFrame: Baseline
measure: CD4 count
timeFrame: Baseline
measure: HIV viral load
timeFrame: Baseline
measure: Bone Mineral Density (BMD)
timeFrame: Baseline
measure: Smoking Status
timeFrame: Baseline
measure: Blood pressure
timeFrame: Baseline
measure: Lipids (Total cholesterol, Low-density lipoprotein (LDL), High-density lipoprotein (HDL), Triglycerides (TG))
timeFrame: Baseline
measure: Diabetes status
timeFrame: Baseline
measure: Aspirin usage
timeFrame: Baseline
measure: Statin usage
timeFrame: Baseline
measure: ASCVD Risk Score
timeFrame: Baseline
measure: Urine Albumin
timeFrame: Baseline
measure: Glomerular Filtration Rate
timeFrame: Baseline
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland, Baltimore
state: Maryland
Study officials:
affiliation: UMB
name: Ann Gruber-Baldini, PhD
role: PRINCIPAL_INVESTIGATOR
References: