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Physical ActivityNCT05702346

Enhance Physical Activity in Low-income Black and Hispanic Adults

A study testing Enhance Physical Activity (EPA) in people with Physical Activity, run by Boston University Charles River Campus.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The present study aims to test the efficacy of a multi-level telehealth intervention to Enhance Physical Activity (EPA) in 300 low-income Black and Hispanic/Latino adults. EPA is eight weeks with four weekly, hour-long parts: virtual group exercises, virtual group discussions, individual PA participation, and… Read more about this study

Who is it for?
Ages 40 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Physical Activity
What is being tested?
Enhance Physical Activity (EPA)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
1 Dec 2023to 30 Nov 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • being between 40-70 years old
  • ability to speak and read English or Spanish
  • ability to comply with study procedures and schedule
  • having <150 minutes of weekly physical activity
  • willingness to give informed consent

Who cannot join

  • not independently ambulatory
  • having other serious health problems that would make it difficult to participate for the duration of the study

About this study

Official title: A Multi-level Telehealth Intervention to Enhance Physical Activity in Low-income Black and Hispanic Adults

The present study aims to test the efficacy of a multi-level telehealth intervention to Enhance Physical Activity (EPA) in 300 low-income Black and Hispanic/Latino adults. EPA is eight weeks with four weekly, hour-long parts: virtual group exercises, virtual group discussions, individual PA participation, and individual phone check-ins. A control group will receive health education. The specific aims are to: 1) test if physical activity increases significantly more among participants assigned to EPA vs. wait-list controls and 2) test if physical function improves significantly more among participants in EPA vs. controls. An exploratory third aim will test mechanisms of change associated with EPA.

Read the detailed description

In the U.S., 77% of Black and 79% of Hispanic/Latino (HLs) adults do not meet physical activity (PA) guidelines to engage in moderate to vigorous PA for 150 minutes each week compared to 73% of White adults. Low PA leads to chronic conditions such as cardiovascular disease, type 2 diabetes, and obesity that result in disability and premature death. For Black and HL adults, low PA compounds predispositions to these conditions. Despite the urgent need to increase PA among Black and HL adults, solutions to increase PA are not tailored to this population. Poverty is more than double for Black (19.5%) and HLs (17%) compared to non-HL White adults (8.2%) and meeting PA standards increases with income. Lack of access to costly exercise facilities and living in unsafe neighborhoods contribute to low PA among Black and HL adults. As an alternative to traditional approaches, virtual guidance (i.e., telehealth) is a feasible and effective way to overcome the lack of access to facilities and PA participation in unsafe environments. The present study aims to test the efficacy of a multi-level telehealth intervention to Enhance Physical Activity (EPA) in 300 low-income Black and HLs. This full-scale, well-powered efficacy study builds on a Phase 1 pilot-controlled trial of EPA that showed high feasibility and acceptability in low-income Black and HLs. EPA is eight weeks with four weekly, hour-long parts: virtual group exercises, virtual group discussions, individual PA participation, and individual phone check-ins. Using a socio-ecological model of behavior change, EPA addresses PA and physical function at both intrapersonal (individual PA participation and individual phone check-ins) and interpersonal (virtual group exercises and virtual group discussions) levels. A control group will receive health education with the option to receive EPA later. All participants will attend four visits: pre-test, post-test 1 after EPA, post-test 2 (6 months after post-test 1), and post-test 3 (12 months after post-test 1). EPA is unique compared to other PA interventions as it combines standard PA intervention components with factors vital for increasing PA in Black and HLs while leveraging social connection: culturally relevant support, group discussions targeting discrimination, a telehealth format accessible to low-income people, and activities using everyday items or body weight to account for lack of equipment. The specific aims are to: 1) test if PA increases significantly more among participants assigned to EPA vs. wait-list controls and 2) test if physical function improves significantly more among participants in EPA vs. controls. An exploratory aim is to test mechanisms of change associated with EPA. Based on the sociocultural component of the National Institute on Minority Health and Health Disparities Research Framework, we hypothesize that social connection will mediate PA and physical function outcomes for those who receive the EPA intervention. This research can elucidate behavioral mechanisms responsible for low PA in low-income Black and HL adults and lead to scalable and sustainable multi-level interventions to support increased PA for Black and HL communities.

Being tested
Enhance Physical Activity (EPA)
Keywords
exercise
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Enhance Physical Activity (EPA)Behavioural

    EPA is eight weeks with four weekly, hour-long parts: virtual group exercises, virtual group discussions, individual PA participation, and individual phone check-ins.

Study groups in NCT05702346
Study groupRoleWhat they receive
InterventionExperimentalParticipants will receive the EPA intervention.
Receives: Behavioral: Enhance Physical Activity (EPA)
ControlActive comparatorThis is the control group who will receive written information about health.
Receives: Behavioral: Enhance Physical Activity (EPA)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Self-Reported Physical activity

    physical activity via the Physical Activity Scale for the Elderly

    Measured: 12 months

  2. Objectively measured Physical activity

    accelerometers

    Measured: 12 months

  3. Physical function

    physical function via the Short Physical Performance Battery

    Measured: 12 months

Secondary outcomes (3)
  1. Social determinants of health

    surveys from the PhenX toolbox

    Measured: 12 months

  2. Social connection

    Social Connectedness questionnaire

    Measured: 12 months

  3. Strength

    strength with a hand-held dynamometer

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2023
  2. Study start1 Dec 2023 (estimated)
  3. Primary completion30 Jan 2024 (estimated)
  4. Study completion30 Nov 2024 (estimated)

Why it stopped: Did not receive funding to run study

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05702346
Sponsor's protocol ID
PA20183
Status last verified
Jan 2023
First submitted
10 Jan 2023
Last updated
20 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Deidentified data will be shared with any interested parties and will be disseminated via conferences.

Questions about this trial

What is this clinical trial studying?

A study testing Enhance Physical Activity (EPA) in people with Physical Activity, run by Boston University Charles River Campus.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Self-Reported Physical activity (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.

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