Enhance Physical Activity in Low-income Black and Hispanic Adults

NCT05702346 | Not Yet Recruiting

• 1 other identifier: PA20183
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Physical Activity

Keywords

exercise

Outcome Measures

Primary Outcomes (3)

• Self-Reported Physical activity

  physical activity via the Physical Activity Scale for the Elderly

  12 months

• Objectively measured Physical activity

  accelerometers

  12 months

• Physical function

  physical function via the Short Physical Performance Battery

  12 months

Secondary Outcomes (3)

• Social determinants of health

  12 months

• Social connection

  12 months

• Strength

  12 months

Study Arms (2)

Intervention

EXPERIMENTAL

Participants will receive the EPA intervention.

Behavioral: Enhance Physical Activity (EPA)

Control

ACTIVE COMPARATOR

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

Behavioral: Enhance Physical Activity (EPA)

Interventions

Enhance Physical Activity (EPA) BEHAVIORAL

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

Control; Intervention

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Boston University Charles River Campus: lead

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 10, 2023
• First Posted: January 27, 2023
• Study Start: December 1, 2023
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): November 30, 2028
• Last Updated: January 27, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: All scientific data generated from this project will be made available as soon as possible, and no later than the time of publication or the end of the funding period, whichever comes first. The duration of preservation and sharing of the data will be a minimum of 10 years after the funding period.
• Access Criteria: There are no anticipated factors or limitations that will affect the access, distribution or reuse of the de-identified scientific data generated by the study.