HIVNCT03708640
mHealth Physical Activity Trial for Older HIV-infected Adults (mFIT)
A study testing Digital Activity Tracker, Smart Text Messaging and Physical Activity Counseling in people with HIV, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- Digital Activity Tracker, Smart Text Messaging and Physical Activity Counseling
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Nov 2018to 10 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- HIV
- Being tested
- Digital Activity Tracker, Smart Text Messaging, Physical Activity Counseling
- Keywords
- Frailty, Physical Activity, HIV, Aging, Exercise, mHealth, smartphone, activity tracker, pedometer, text messaging, Short Message Service (SMS)
- Medical subject headings
- Frailty, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Activity TrackerOther
Group wears physical activity tracker and receives physical activity feedback information informed by the tracker
Smart Text MessagingOther
Group receives personalized, health coaching via "smart" text messages
Physical Activity CounselingOther
Group receives baseline counseling on physical activity
| Study group | Role | What they receive |
|---|---|---|
| Physical Activity Counseling | Placebo comparator | Group receives baseline physical activity counseling.
Group does not receive personalized, health coaching via "smart" text messages. Receives: 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. Receives: Other: Digital Activity Tracker; Other: Smart Text Messaging; Other: Physical Activity Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Mean daily step count
Mean daily step count will be assessed using a digital physical activity tracker
Measured: Baseline, 12 weeks
Secondary outcomes (9)
Change in Frailty as assessed by the Fried-based physical frailty phenotype
Frailty evaluated based on the standard 5 point Fried-based frailty phenotype construct (slow gait, weakness, weight loss, exhaustion, low physical activity)
Measured: Baseline, 12 weeks
Change in Physical Fitness as assessed by 12 minute walk
Physical fitness of participants will be assessed by the ability to do a 12 minute walk
Measured: Baseline, 12 weeks
Change in Muscle strength as assessed by isokinetic resistance
Muscle strength evaluated using isokinetic resistance testing on a Biodex system measuring peak torque expressed as foot pounds (lbs)
Measured: Baseline, 12 weeks
Percent change in fat mass
Fat mass will be measured using the dual-energy x-ray absorptiometry (DXA) scan
Measured: Baseline, 12 weeks
Percent change in lean mass
Lean mass will be measured using the dual-energy x-ray absorptiometry (DXA) scan
Measured: Baseline, 12 weeks
Change in Physical performance as assessed by the physical performance battery
Physical performance evaluated with the short physical performance battery
Measured: Baseline, 12 weeks
Change in Quality of Life as assessed by the Medical Outcomes Study HIV Health Survey (MOS-HIV)
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.
Measured: Baseline, 12 weeks
Change in Interleukin-6 (IL-6) concentration
Interleukin-6 concentration in pg/ml will be measured at baseline and be compared to the concentration at 12 weeks to assess any change
Measured: Baseline, 12 weeks
Change in soluble Tumor Necrosis Factor Receptor 1 (sTNFR1)
sTNFR1 concentration in ng/ml will be measured at baseline and be compared to the concentration at 12 weeks to assess any change
Measured: Baseline, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2018
- Study start30 Nov 2018
- Primary completion10 Mar 2020
- Study completion10 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Damani Piggott, MD, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03708640
- Sponsor's protocol ID
- IRB00169068
- Other IDs
- K23AI108357
- Status last verified
- Jun 2022
- First submitted
- 9 Oct 2018
- Last updated
- 5 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 11253156
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Pilot Study to Evaluate the Effect of a Mobile Health Physical Activity Intervention for HIV-associated Frailty
- ClinicalTrials.gov ID
- NCT03708640
- Acronym / sponsor ID
- IRB00169068
- Conditions
- HIV
- Keywords
- Frailty, Physical Activity, HIV, Aging, Exercise, mHealth, smartphone, activity tracker
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 30 Nov 2018 (actual)
- Primary completion
- 10 Mar 2020 (actual)
- Study completion
- 10 Mar 2020 (actual)
- First posted
- 17 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical Activity Counseling | Placebo comparator | Other: Physical Activity CounselingGroup receives baseline physical activity counseling. Group does not receive personalized, health coaching via "smart" text messages. |
| Digital Activity Tracker/Smart Text Messaging | Experimental | Other: Digital Activity Tracker, Other: Smart Text Messaging, Other: Physical Activity CounselingGroup receives baseline physical activity counseling. Group receives personalized, health coaching via "smart" text messages informed by digital activity tracker. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital Activity TrackerGroup wears physical activity tracker and receives physical activity feedback information informed by the tracker | Other | Digital Activity Tracker/Smart Text Messaging |
| Smart Text MessagingGroup receives personalized, health coaching via "smart" text messages | Other | Digital Activity Tracker/Smart Text Messaging |
| Physical Activity CounselingGroup receives baseline counseling on physical activity | Other | Digital Activity Tracker/Smart Text Messaging, Physical Activity Counseling |
Primary outcome
Change in Mean daily step count
Time frame: Baseline, 12 weeks
Mean daily step count will be assessed using a digital physical activity tracker
9 secondary outcomes
Change in Frailty as assessed by the Fried-based physical frailty phenotype
Time frame: Baseline, 12 weeks
Change in Physical Fitness as assessed by 12 minute walk
Time frame: Baseline, 12 weeks
Change in Muscle strength as assessed by isokinetic resistance
Time frame: Baseline, 12 weeks
Percent change in fat mass
Time frame: Baseline, 12 weeks
Percent change in lean mass
Time frame: Baseline, 12 weeks
Change in Physical performance as assessed by the physical performance battery
Time frame: 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
Change in Interleukin-6 (IL-6) concentration
Time frame: Baseline, 12 weeks
Change in soluble Tumor Necrosis Factor Receptor 1 (sTNFR1)
Time frame: Baseline, 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2022.
- Background: PubMed 11253156Fried 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Damani Piggott, MD, PhD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Activity Tracker, Smart Text Messaging and Physical Activity Counseling in people with HIV, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Mean daily step count (time frame: Baseline, 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03708640, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2022.