Enhance Physical Activity in Low-income Black and Hispanic Adults

Sponsor
Boston University Charles River Campus (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05702346
Collaborator
(none)
300
2
60

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Enhance Physical Activity (EPA)
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
300 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Multi-level Telehealth Intervention to Enhance Physical Activity in Low-income Black and Hispanic Adults
Anticipated Study Start Date :
Dec 1, 2023
Anticipated Primary Completion Date :
Jun 30, 2028
Anticipated Study Completion Date :
Nov 30, 2028

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention

Participants will receive the EPA intervention.

Behavioral: 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.

Active Comparator: Control

This is the control group who will receive written information about health.

Behavioral: 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.

Outcome Measures

Primary Outcome Measures

  1. Self-Reported Physical activity [12 months]

    physical activity via the Physical Activity Scale for the Elderly

  2. Objectively measured Physical activity [12 months]

    accelerometers

  3. Physical function [12 months]

    physical function via the Short Physical Performance Battery

Secondary Outcome Measures

  1. Social determinants of health [12 months]

    surveys from the PhenX toolbox

  2. Social connection [12 months]

    Social Connectedness questionnaire

  3. Strength [12 months]

    strength with a hand-held dynamometer

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Boston University Charles River Campus

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Simone V. Gill, Associate Professor, Boston University Charles River Campus
ClinicalTrials.gov Identifier:
NCT05702346
Other Study ID Numbers:
  • PA20183
First Posted:
Jan 27, 2023
Last Update Posted:
Jan 27, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Simone V. Gill, Associate Professor, Boston University Charles River Campus

Study Results

No Results Posted as of Jan 27, 2023