Enhance Physical Activity in Low-income Black and Hispanic Adults

Not Applicable

Not yet recruiting

• Conditions: Physical Activity
• Interventions: Behavioral: Enhance Physical Activity (EPA)

• Registration Number: NCT05702346
• Lead Sponsor: Boston University Charles River Campus

Brief 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 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 Timeline

• Status Verified: 2023-01
• Study First Submitted: 2023-01-10
• Study First Submitted QC: 2023-01-18
• Last Update Submitted: 2023-01-18
• Study First Posted: 2023-01-27
• Last Update Posted: 2023-01-27
• Study Start: 2023-12-01
• Primary Completion: 2028-06-30
• Study Completion: 2028-11-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• 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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Enhance Physical Activity (EPA)	Participants will receive the EPA intervention.
Control	Enhance Physical Activity (EPA)	This is the control group who will receive written information about health.

Primary Outcome Measures

Name	Time	Method
Self-Reported Physical activity	12 months	physical activity via the Physical Activity Scale for the Elderly
Objectively measured Physical activity	12 months	accelerometers
Physical function	12 months	physical function via the Short Physical Performance Battery

Secondary Outcome Measures

Name	Time	Method
Strength	12 months	strength with a hand-held dynamometer
Social connection	12 months	Social Connectedness questionnaire
Social determinants of health	12 months	surveys from the PhenX toolbox