NCT03708640

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable hiv

Timeline
Completed

Started Nov 2018

Shorter than P25 for not_applicable hiv

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 9, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 17, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

November 30, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2020

Completed
Last Updated

July 5, 2022

Status Verified

June 1, 2022

Enrollment Period

1.3 years

First QC Date

October 9, 2018

Last Update Submit

June 30, 2022

Conditions

HIV

Keywords

FrailtyPhysical ActivityHIVAgingExercisemHealthsmartphoneactivity trackerpedometertext messagingShort Message Service (SMS)

Outcome Measures

Primary Outcomes (1)

  • Change in Mean daily step count

    Mean daily step count will be assessed using a digital physical activity tracker

    Baseline, 12 weeks

Secondary Outcomes (9)

  • Change in Frailty as assessed by the Fried-based physical frailty phenotype

    Baseline, 12 weeks

  • Change in Physical Fitness as assessed by 12 minute walk

    Baseline, 12 weeks

  • Change in Muscle strength as assessed by isokinetic resistance

    Baseline, 12 weeks

  • Percent change in fat mass

    Baseline, 12 weeks

  • Percent change in lean mass

    Baseline, 12 weeks

  • +4 more secondary outcomes

Study Arms (2)

Physical Activity Counseling

PLACEBO COMPARATOR

Group receives baseline physical activity counseling. Group does not receive personalized, health coaching via "smart" text messages.

Other: Physical Activity Counseling

Digital Activity Tracker/Smart Text Messaging

EXPERIMENTAL

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

Other: Digital Activity TrackerOther: Smart Text MessagingOther: Physical Activity Counseling

Interventions

Digital Activity TrackerOTHER

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

Digital Activity Tracker/Smart Text Messaging
Smart Text MessagingOTHER

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

Digital Activity Tracker/Smart Text Messaging
Physical Activity CounselingOTHER

Group receives baseline counseling on physical activity

Digital Activity Tracker/Smart Text MessagingPhysical Activity Counseling

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

Related Publications (1)

  • 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.

    PMID: 11253156BACKGROUND

MeSH Terms

Conditions

FrailtyMotor Activity

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Damani Piggott, MD, PhD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 9, 2018

First Posted

October 17, 2018

Study Start

November 30, 2018

Primary Completion

March 10, 2020

Study Completion

March 10, 2020

Last Updated

July 5, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)