Behavioral Activation, Nutrition, and Activity Intervention

NCT ID: NCT06239961

Last Updated: 2025-07-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-23

Study Completion Date

2025-06-19

Brief Summary

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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

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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

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HIV

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

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 Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Physical Activity Coaching

Intervention Type BEHAVIORAL

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

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.

Group Type EXPERIMENTAL

Nutritional Coaching

Intervention Type BEHAVIORAL

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

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.

Group Type EXPERIMENTAL

Social Connection

Intervention Type BEHAVIORAL

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

Interventions

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Social Connection

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

Intervention Type BEHAVIORAL

Nutritional Coaching

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

Intervention Type BEHAVIORAL

Physical Activity Coaching

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

University of Maryland, Baltimore

OTHER

Sponsor Role lead

Responsible Party

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Ann Gruber-Baldini

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ann Gruber-Baldini, PhD

Role: PRINCIPAL_INVESTIGATOR

UMB

Locations

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University of Maryland, Baltimore

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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5P30AG028747-17

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HP-00107100

Identifier Type: -

Identifier Source: org_study_id

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