mHealth Physical Activity Trial for Older HIV-infected Adults (mFIT)

NCT ID: NCT03708640

Last Updated: 2022-07-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-30

Study Completion Date

2020-03-10

Brief Summary

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This pilot study will examine the effect of a mobile health text messaging platform linked to a digital physical activity tracker on physical activity among persons living with HIV and frailty.

Detailed Description

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HIV is associated with frailty, an important aging-related phenotype associated with adverse clinical outcomes. The investigators propose that personalized health coaching using a digital activity tracker with mobile health text messaging can increase physical activity in this population. The total duration of the intervention will be 12 weeks.

Conditions

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HIV

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Physical Activity Counseling

Group receives baseline physical activity counseling.

Group does not receive personalized, health coaching via "smart" text messages.

Group Type PLACEBO_COMPARATOR

Physical Activity Counseling

Intervention Type OTHER

Group receives baseline counseling on physical activity

Digital Activity Tracker/Smart Text Messaging

Group receives baseline physical activity counseling.

Group receives personalized, health coaching via "smart" text messages informed by digital activity tracker.

Group Type EXPERIMENTAL

Digital Activity Tracker

Intervention Type OTHER

Group wears physical activity tracker and receives physical activity feedback information informed by the tracker

Smart Text Messaging

Intervention Type OTHER

Group receives personalized, health coaching via "smart" text messages

Physical Activity Counseling

Intervention Type OTHER

Group receives baseline counseling on physical activity

Interventions

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Digital Activity Tracker

Group wears physical activity tracker and receives physical activity feedback information informed by the tracker

Intervention Type OTHER

Smart Text Messaging

Group receives personalized, health coaching via "smart" text messages

Intervention Type OTHER

Physical Activity Counseling

Group receives baseline counseling on physical activity

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* HIV-1 positive adults of any gender
* Age 50 years and older
* Frailty score of 2 or greater (at least 1 criteria is slow gait speed or decreased grip strength)
* Ability to provide informed consent

Exclusion Criteria

* Any physical condition that would prevent or prohibit moderate physical activity
* \>3 days per week of moderate or vigorous leisure time activity lasting \>30 min/day
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Damani Piggott, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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Johns Hopkins University

Baltimore, Maryland, United States

Site Status

Countries

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United States

References

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Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.

Reference Type BACKGROUND
PMID: 11253156 (View on PubMed)

Other Identifiers

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K23AI108357

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00169068

Identifier Type: -

Identifier Source: org_study_id

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