RECRUITING

Optimization of a Behavioral Intervention to Increase Physical Activity in Older Adults Living With HIV

Conditions

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this clinical trial is to examine 3 interventions designed to increase physical activity in older adults with HIV. We will examine 3 potential components of an intervention package: physical activity coaching, cognitive behavioral therapy targeted toward common barriers to physical activity such as low motivation or chronic pain, and a Fitbit-based social support intervention. Our primary outcome will be physical activity, defined as steps per day. Results will guide choice of intervention components to be used in an optimized behavioral intervention.

Official Title

Optimization of a Behavioral Intervention to Increase Physical Activity in Older Adults Living With HIV

Quick Facts

Study Start:2023-06-21

Study Completion:2027-08-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05752500

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. HIV positive: defined by HIV antibody, detectable HIV RNA in plasma, or a note from the participant's HIV care provider. 2. Must be on continuous antiretroviral therapy (ART) for \> 3 months, as assessed via self-report. 3. Low PA: defined as self-report of \< 90 minutes of moderate-vigorous PA (MVPA) per week in the previous 3 months AND less than 14 hours per week of sustained walking in the previous 4 weeks. 4. Medically cleared for moderate PA. If participants report a) a history of cardiovascular disease including known coronary artery disease, peripheral vascular disease, heart failure, or stroke; or b) chest pain, shortness of breath, or dizziness or syncope either at rest or during activity in the past 3 months, then they must have medical clearance by a physician or primary care provider. 5. Age 50 years or older. 6. Proficiency in English: sufficient to engage in informed consent, understand assessments and materials provided, and engage and use Fitbit application (all materials provided in English). 7. Capacity to consent, documented by acceptable answers in a consent "teach-back" process. 8. Score of greater than 16 on the MOCA 9. Able to ambulate without assistive devices 10. Ability to use the FitBit application, as demonstrated to study staff.	* Exclusion Criteria 1. Medical conditions or physical or neurocognitive limitations that interfere with PA or study participation. 2. Hazardous substance use, assessed via a score ≥15 on the Alcohol Use Disorders Identification Test (AUDIT) or ≥6 on the Drug Abuse Screening Test (DAST).

Inclusion Criteria

Exclusion Criteria

1. HIV positive: defined by HIV antibody, detectable HIV RNA in plasma, or a note from the participant's HIV care provider.
2. Must be on continuous antiretroviral therapy (ART) for \> 3 months, as assessed via self-report.
3. Low PA: defined as self-report of \< 90 minutes of moderate-vigorous PA (MVPA) per week in the previous 3 months AND less than 14 hours per week of sustained walking in the previous 4 weeks.
4. Medically cleared for moderate PA. If participants report a) a history of cardiovascular disease including known coronary artery disease, peripheral vascular disease, heart failure, or stroke; or b) chest pain, shortness of breath, or dizziness or syncope either at rest or during activity in the past 3 months, then they must have medical clearance by a physician or primary care provider.
5. Age 50 years or older.
6. Proficiency in English: sufficient to engage in informed consent, understand assessments and materials provided, and engage and use Fitbit application (all materials provided in English).
7. Capacity to consent, documented by acceptable answers in a consent "teach-back" process.
8. Score of greater than 16 on the MOCA
9. Able to ambulate without assistive devices
10. Ability to use the FitBit application, as demonstrated to study staff.

* Exclusion Criteria
1. Medical conditions or physical or neurocognitive limitations that interfere with PA or study participation.
2. Hazardous substance use, assessed via a score ≥15 on the Alcohol Use Disorders Identification Test (AUDIT) or ≥6 on the Drug Abuse Screening Test (DAST).

Contacts and Locations

Study Contact

Bailey O'Keeffe, MS

CONTACT

401-455-6219

bokeeffe@butler.org

Lisa Uebelacker, PhD

CONTACT

401-455-6381

luebelacker@butler.org

Principal Investigator

Lisa Uebelacker, PhD

PRINCIPAL_INVESTIGATOR

Butler Hospital

Jason Baker, MD

PRINCIPAL_INVESTIGATOR

Hennepin Healthcare

Study Locations (Sites)

Hennepin Healthcare Research Institute

Minneapolis, Minnesota, 54415

United States

Lifespan Affiliates

Providence, Rhode Island, 02904

United States

Collaborators and Investigators

Sponsor: Butler Hospital

Lisa Uebelacker, PhD, PRINCIPAL_INVESTIGATOR, Butler Hospital
Jason Baker, MD, PRINCIPAL_INVESTIGATOR, Hennepin Healthcare

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-21

Study Completion Date2027-08-31

Study Record Updates

Study Start Date2023-06-21

Study Completion Date2027-08-31

Terms related to this study

Additional Relevant MeSH Terms

Hiv
Physical Inactivity
Aging