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.
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)
- Type of treatment
- Lifestyle or therapy programme
- 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.
- Conditions
- Physical Activity
- 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 group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participants will receive the EPA intervention. Receives: Behavioral: Enhance Physical Activity (EPA) |
| Control | Active comparator | This 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.
Self-Reported Physical activity
physical activity via the Physical Activity Scale for the Elderly
Measured: 12 months
Objectively measured Physical activity
accelerometers
Measured: 12 months
Physical function
physical function via the Short Physical Performance Battery
Measured: 12 months
Secondary outcomes (3)
Social determinants of health
surveys from the PhenX toolbox
Measured: 12 months
Social connection
Social Connectedness questionnaire
Measured: 12 months
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.
- First posted27 Jan 2023
- Study start1 Dec 2023 (estimated)
- Primary completion30 Jan 2024 (estimated)
- Study completion30 Nov 2024 (estimated)
Why it stopped: Did not receive funding to run study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Boston University Charles River Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Simone V Gill, PhD, Principal investigator, Boston University Charles River Campus
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.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-level Telehealth Intervention to Enhance Physical Activity in Low-income Black and Hispanic Adults
- ClinicalTrials.gov ID
- NCT05702346
- Acronym / sponsor ID
- PA20183
- Conditions
- Physical Activity
- Keywords
- exercise
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Did not receive funding to run study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Boston University Charles River CampusUniversity, hospital or other
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 30 Jan 2024 (estimated)
- Study completion
- 30 Nov 2024 (estimated)
- First posted
- 27 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Enhance Physical Activity (EPA)Participants will receive the EPA intervention. |
| Control | Active comparator | Behavioral: Enhance Physical Activity (EPA)This is the control group who will receive written information about health. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- not independently ambulatory
- having other serious health problems that would make it difficult to participate for the duration of the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enhance Physical Activity (EPA)EPA is eight weeks with four weekly, hour-long parts: virtual group exercises, virtual group discussions, individual PA participation, and individual phone check-ins. | Behavioural | Control, Intervention |
Primary outcome
Self-Reported Physical activity
Time frame: 12 months
physical activity via the Physical Activity Scale for the Elderly
Objectively measured Physical activity
Time frame: 12 months
accelerometers
Physical function
Time frame: 12 months
physical function via the Short Physical Performance Battery
3 secondary outcomes
Social determinants of health
Time frame: 12 months
Social connection
Time frame: 12 months
Strength
Time frame: 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Individual participant dataSharing planned: No. Deidentified data will be shared with any interested parties and will be disseminated via conferences.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simone V Gill, PhD principal investigator
Boston University Charles River Campus
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.