Multi-Component Behavioral Activation, Nutrition, and Activity Intervention for Persons Aging With HIV
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Sleep Efficiency (SE) with Actigraphy
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •1) No severe cognitive impairment
研究组 & 干预措施
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.
干预措施: Physical Activity Coaching (Behavioral)
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.
干预措施: Nutritional Coaching (Behavioral)
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.
干预措施: Social Connection (Behavioral)
结局指标
主要结局
Sleep Efficiency (SE) with Actigraphy
时间窗: Baseline and Week 16
SE will be measured by a wearable sensor, from baseline to the final week of the intervention.
Loneliness
时间窗: 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
时间窗: Baseline and Week 16
TST will be measured by a wearable sensor, from baseline to the final week of the intervention.
Nutritional Intake
时间窗: 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
时间窗: 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
时间窗: 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 Onset Latency (SOL) with Actigraphy
时间窗: Baseline and Week 16
SOL will be measured by a wearable sensor, from baseline to the final week of the intervention.
Social Isolation
时间窗: 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
时间窗: 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.
次要结局
- Education(Baseline)
- Race(Baseline)
- CD4 count(Baseline)
- Age(Baseline)
- Generalized Anxiety Disorder 7(Baseline and Week 16)
- Engagement in activities(Baseline and Week 16)
- Reece 9-item HIV-related Stigma Scale(Baseline and Week 16)
- Sexual preference(Baseline)
- Aspirin usage(Baseline)
- ASCVD Risk Score(Baseline)
- Gender at birth(Baseline)
- Bone Mineral Density (BMD)(Baseline)
- Late Life Function and Disability Instrument(Baseline and Week 16)
- Gender identity now(Baseline)
- Smoking Status(Baseline)
- Blood pressure(Baseline)
- Lipids (Total cholesterol, Low-density lipoprotein (LDL), High-density lipoprotein (HDL), Triglycerides (TG))(Baseline)
- Statin usage(Baseline)
- HIV viral load(Baseline)
- Diabetes status(Baseline)
- Urine Albumin(Baseline)
- Glomerular Filtration Rate(Baseline)
研究者
Ann Gruber-Baldini
Principal Investigator
University of Maryland, Baltimore