Behavioral Activation, Nutrition, and Activity Intervention

NCT06239961 | Completed DMC

• 2 other identifiers: HP-001071005P30AG028747-17
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV

Keywords

Aging; HIV; Social engagement; Nutrition; Physical activity

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (22)

• Generalized Anxiety Disorder 7

  Baseline and Week 16

• Late Life Function and Disability Instrument

  Baseline and Week 16

• Engagement in activities

  Baseline and Week 16

• Reece 9-item HIV-related Stigma Scale

  Baseline and Week 16

• Age

  Baseline

Study Arms (3)

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.

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.

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.

Behavioral: Social Connection

Interventions

Social Connection BEHAVIORAL

6 weekly Behavioral Activation Intervention calls with a 1 hour duration for each call.

Behavioral Activation

Nutritional Coaching BEHAVIORAL

4 weekly nutritional coaching calls with a Registered Dietician with a 1 hour duration for each call.

Nutritional Assessment

Physical Activity Coaching BEHAVIORAL

4 weekly physical activity coaching sessions with a 1 hour duration for each call.

Physical Activity Coaching

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \) No severe cognitive impairment

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Maryland, Baltimore

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Ann Gruber-Baldini, PhD

  UMB

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: December 6, 2023
• First Posted: February 2, 2024
• Study Start: September 23, 2024
• Primary Completion: June 19, 2025
• Study Completion: June 19, 2025
• Last Updated: July 4, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)