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

June 30, 2022 updated by: Johns Hopkins University

A Prospective Randomized Pilot Study to Evaluate the Effect of a Mobile Health Physical Activity Intervention for HIV-associated Frailty

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Physical Activity Counseling

Group receives baseline physical activity counseling.

Group does not receive personalized, health coaching via "smart" text messages.
Other: Physical Activity Counseling
Group receives baseline counseling on physical activity
Experimental: 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.
Other: Physical Activity Counseling
Group receives baseline counseling on physical activity
Other: Digital Activity Tracker
Group wears physical activity tracker and receives physical activity feedback information informed by the tracker
Other: Smart Text Messaging
Group receives personalized, health coaching via "smart" text messages

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Mean daily step count
Time Frame: Baseline, 12 weeks
Mean daily step count will be assessed using a digital physical activity tracker
Baseline, 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Frailty as assessed by the Fried-based physical frailty phenotype
Time Frame: Baseline, 12 weeks
Frailty evaluated based on the standard 5 point Fried-based frailty phenotype construct (slow gait, weakness, weight loss, exhaustion, low physical activity)
Baseline, 12 weeks
Change in Physical Fitness as assessed by 12 minute walk
Time Frame: Baseline, 12 weeks
Physical fitness of participants will be assessed by the ability to do a 12 minute walk
Baseline, 12 weeks
Change in Muscle strength as assessed by isokinetic resistance
Time Frame: Baseline, 12 weeks
Muscle strength evaluated using isokinetic resistance testing on a Biodex system measuring peak torque expressed as foot pounds (lbs)
Baseline, 12 weeks
Percent change in fat mass
Time Frame: Baseline, 12 weeks
Fat mass will be measured using the dual-energy x-ray absorptiometry (DXA) scan
Baseline, 12 weeks
Percent change in lean mass
Time Frame: Baseline, 12 weeks
Lean mass will be measured using the dual-energy x-ray absorptiometry (DXA) scan
Baseline, 12 weeks
Change in Physical performance as assessed by the physical performance battery
Time Frame: Baseline, 12 weeks
Physical performance evaluated with the short physical performance battery
Baseline, 12 weeks
Change in Quality of Life as assessed by the Medical Outcomes Study HIV Health Survey (MOS-HIV)
Time Frame: Baseline, 12 weeks
The Medical Outcomes Study HIV Health Survey (MOS-HIV) is a brief, comprehensive measure of health-related quality of life. The 35-item questionnaire includes 10 dimensions (pain, physical, role, health perceptions, social and cognitive functioning, energy, mental health, health distress and quality of life). Each dimension is scored on a 0-100 scale (a higher score indicates better health related quality of life). An overall score is obtained through a summation of z scores from each domain.
Baseline, 12 weeks
Change in Interleukin-6 (IL-6) concentration
Time Frame: Baseline, 12 weeks
Interleukin-6 concentration in pg/ml will be measured at baseline and be compared to the concentration at 12 weeks to assess any change
Baseline, 12 weeks
Change in soluble Tumor Necrosis Factor Receptor 1 (sTNFR1)
Time Frame: Baseline, 12 weeks
sTNFR1 concentration in ng/ml will be measured at baseline and be compared to the concentration at 12 weeks to assess any change
Baseline, 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

  • Principal Investigator: Damani Piggott, MD, PhD, Johns Hopkins University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 30, 2018

Primary Completion (Actual)

March 10, 2020

Study Completion (Actual)

March 10, 2020

Study Registration Dates

First Submitted

October 9, 2018

First Submitted That Met QC Criteria

October 15, 2018

First Posted (Actual)

October 17, 2018

Study Record Updates

Last Update Posted (Actual)

July 5, 2022

Last Update Submitted That Met QC Criteria

June 30, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IRB00169068
  • K23AI108357 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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