NCT05702346

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2023

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 10, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 27, 2023

Completed
10 months until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2024

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2024

Completed
Last Updated

July 20, 2026

Status Verified

January 1, 2023

Enrollment Period

2 months

First QC Date

January 10, 2023

Last Update Submit

July 17, 2026

Conditions

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

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

ControlIntervention

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Simone V Gill, PhD

    Boston University Charles River Campus

    PRINCIPAL INVESTIGATOR
0

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
SPONSOR

Study Record Dates

First Submitted

January 10, 2023

First Posted

January 27, 2023

Study Start

December 1, 2023

Primary Completion

January 30, 2024

Study Completion

November 30, 2024

Last Updated

July 20, 2026

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Deidentified data will be shared with any interested parties and will be disseminated via conferences.