Physical ActivityNCT02850770
Physical Activity and Social Support Prompting Via Phone Messaging
A study testing Pedometers and Walking Logs, Phone Messaging and Family/Friend Support in people with Physical Activity, run by University of Southern California.
Trial summary
The objective of this study was to investigate the feasibility, perceived usefulness, and potential effectiveness of a short text or voice message intervention to activate 1) physical activity behavior change among low-income, urban, Latino patients in diabetes management and 2) supportive behaviors by family members… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Physical Activity
- What is being tested?
- Pedometers and Walking Logs, Phone Messaging and Family/Friend Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- Apr 2015to Nov 2015
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than or equal to 18 years
- Diagnosis of type 2 diabetes
- No medical conditions restricting patient from beginning a walking program
- Preferred language of English or Spanish, self-identifies as a Hispanic
- Ability to walk without the use of assistive devices such as canes or walkers
- Available to attend three interviews at the clinic
- Does not plan to move away from the region or be out of the country during the next three months
- Has a working phone where they can receive regular short text or voice messages for three months
Who cannot join
- Pregnant or breastfeeding women
About this study
Official title: Phone Messaging for Physical Activity and Social Support Prompting Among Low-Income Latino Patients: A Randomized Pilot Study
The objective of this study was to investigate the feasibility, perceived usefulness, and potential effectiveness of a short text or voice message intervention to activate 1) physical activity behavior change among low-income, urban, Latino patients in diabetes management and 2) supportive behaviors by family members or close friends.
Read the detailed description
Despite the promise of phone-based interventions to effectively support diabetes self-management (DSM), little is known about their impact on the outcomes of highly vulnerable populations such as low-income, inner-city, racial/ethnic minorities. And while phone-based interventions have generally been successful at reaching and engaging adults with diabetes, they have failed to do the same with family members/friends (FF) whom are a promising source of ongoing support for DSM. The objective of this study was to investigate the feasibility, perceived usefulness, and potential effectiveness of a short text or voice message (ST/VM) intervention to activate 1) physical activity (PA) behavior change among low-income, urban, Latino patients in diabetes management and 2) supportive behaviors by FF. The investigators conducted a 12-week pilot study in which participants were randomized into one of three study arms: control, phone messaging (PM), and phone messaging plus social support from FF (PM+FF). Participants were recruited in person from a diabetes management program at a safety-net ambulatory care clinic. All participants were given a pedometer and walking log for self-monitoring. Participants in the PM and PM+FF arms received ST/VMs as reminders to review daily step goals and to self-monitor; explaining the benefits of regular PA, importance of regular PA to daily life, and ways to overcome commonly identified barriers to PA; asking participants to report on PA performance; providing feedback based on responses. Participants in the PM+FF identified a FF to receive ST/VMs with suggested behaviors that are perceived as supportive by individuals making PA behavior changes. Participants received semi-structured assessments in person at baseline, 6 weeks, and 12 weeks. Participants were asked about the extent to which the program enhanced the participant's ability to make PA behavior changes. The primary outcome measures were daily step counts and perceived FF social support.
- Conditions
- Physical Activity
- Being tested
- Pedometers and Walking Logs, Phone Messaging, Family/Friend Support
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pedometers and Walking LogsBehavioural
Participants were recommended to use the pedometer and walking log to self-monitor how many steps participants walked each day. Participants were recommended to gradually increase daily steps over the course of 12 weeks until reaching 10,000 steps per day. Participants were also recommended to walk at a brisk pace for 3000 of these steps, which roughly translates to 30 minutes per day.
Phone MessagingBehavioural
Participants received short text or voice messages (depending on participant preference) as reminders to review daily step goals and to self-monitor; explaining the benefits of regular physical activity, importance of regular physical activity to daily life, and ways to overcome commonly identified barriers to physical activity; asking participants to report on their physical activity performance; providing feedback based on responses.
Family/Friend SupportBehavioural
Participants identified a family member or close friend (FF) to receive short text or voice messages (depending on FF preference) with suggested behaviors that are perceived as supportive by individuals making physical activity behavior changes.
| Study group | Role | What they receive |
|---|---|---|
| Control | Other | Pedometers and walking logs Receives: Behavioral: Pedometers and Walking Logs |
| Phone Messaging | Experimental | Phone Messaging Receives: Behavioral: Pedometers and Walking Logs; Behavioral: Phone Messaging |
| Phone Messaging + Family/Friend Support | Experimental | Phone Messaging + Family/Friend Support Receives: Behavioral: Pedometers and Walking Logs; Behavioral: Phone Messaging; Behavioral: Family/Friend Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in average daily steps assessed by pedometers
Change in average daily steps assessed using pedometer 7-day data storage
Measured: Baseline, 6 weeks, 12 weeks
Secondary outcomes (4)
Change in body mass index
Change in Body Mass Index, which was calculated as weight (in kilograms) over height squared (in centimeters)
Measured: Baseline, 6 weeks, 12 weeks
Change in exercise self-efficacy assessed using the Exercise Self-Efficacy Scale
Change in exercise self-efficacy assessed using the Exercise Self-Efficacy Scale
Measured: Baseline, 6 weeks, 12 weeks
Change in barriers self-efficacy assessed using the Barriers Self-Efficacy Scale
Change in barriers self-efficacy assessed using the Barriers Self-Efficacy Scale
Measured: Baseline, 6 weeks, 12 weeks
Change in perceived family/friend social support assessed using the Social Support and Exercise Survey
Change in perceived family/friend social support assessed using the Social Support and Exercise Survey
Measured: Baseline, 6 weeks, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2016 (estimated)
- Study startApr 2015
- Primary completionNov 2015
- Study completionNov 2015
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 Physical ActivityStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), Los Angeles County Department of Public Health
- Responsible party
- Principal investigator, Shinyi Wu, University of Southern California
- Investigators
- Shinyi Wu, Ph.D., Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02850770
- Sponsor's protocol ID
- HS-13-00471
- Other IDs
- 3U54NS081764-03S1
- Status last verified
- Mar 2017
- First submitted
- 12 Apr 2016
- Last updated
- 13 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Ramirez M, Wu S. Phone Messaging to Prompt Physical Activity and Social Support Among Low-Income Latino Patients With Type 2 Diabetes: A Randomized Pilot Study. JMIR Diabetes. 2017 Jun 6;2(1):e8. doi: 10.2196/diabetes.7063.
PubMed 30291094
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phone Messaging for Physical Activity and Social Support Prompting Among Low-Income Latino Patients: A Randomized Pilot Study
- ClinicalTrials.gov ID
- NCT02850770
- Acronym / sponsor ID
- HS-13-00471
- Conditions
- Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), Los Angeles County Department of Public Health
- Study start
- Apr 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 1 Aug 2016 (estimated)
- 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.
The objective of this study was to investigate the feasibility, perceived usefulness, and potential effectiveness of a short text or voice message intervention to activate 1) physical activity behavior change among low-income, urban, Latino patients in diabetes management and 2) supportive behaviors by family members or close friends.
Detailed description
Despite the promise of phone-based interventions to effectively support diabetes self-management (DSM), little is known about their impact on the outcomes of highly vulnerable populations such as low-income, inner-city, racial/ethnic minorities. And while phone-based interventions have generally been successful at reaching and engaging adults with diabetes, they have failed to do the same with family members/friends (FF) whom are a promising source of ongoing support for DSM. The objective of this study was to investigate the feasibility, perceived usefulness, and potential effectiveness of a short text or voice message (ST/VM) intervention to activate 1) physical activity (PA) behavior change among low-income, urban, Latino patients in diabetes management and 2) supportive behaviors by FF. The investigators conducted a 12-week pilot study in which participants were randomized into one of three study arms: control, phone messaging (PM), and phone messaging plus social support from FF (PM+FF). Participants were recruited in person from a diabetes management program at a safety-net ambulatory care clinic. All participants were given a pedometer and walking log for self-monitoring. Participants in the PM and PM+FF arms received ST/VMs as reminders to review daily step goals and to self-monitor; explaining the benefits of regular PA, importance of regular PA to daily life, and ways to overcome commonly identified barriers to PA; asking participants to report on PA performance; providing feedback based on responses. Participants in the PM+FF identified a FF to receive ST/VMs with suggested behaviors that are perceived as supportive by individuals making PA behavior changes. Participants received semi-structured assessments in person at baseline, 6 weeks, and 12 weeks. Participants were asked about the extent to which the program enhanced the participant's ability to make PA behavior changes. The primary outcome measures were daily step counts and perceived FF social support.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Other | Behavioral: Pedometers and Walking LogsPedometers and walking logs |
| Phone Messaging | Experimental | Behavioral: Pedometers and Walking Logs, Behavioral: Phone MessagingPhone Messaging |
| Phone Messaging + Family/Friend Support | Experimental | Behavioral: Pedometers and Walking Logs, Behavioral: Phone Messaging, Behavioral: Family/Friend SupportPhone Messaging + Family/Friend Support |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age greater than or equal to 18 years
- Diagnosis of type 2 diabetes
- No medical conditions restricting patient from beginning a walking program
- Preferred language of English or Spanish, self-identifies as a Hispanic
- Ability to walk without the use of assistive devices such as canes or walkers
Key exclusion criteria (1 listed)
- Pregnant or breastfeeding women
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 |
|---|---|---|
| Pedometers and Walking LogsParticipants were recommended to use the pedometer and walking log to self-monitor how many steps participants walked each day. Participants were recommended to gradually increase daily steps over the course of 12 weeks until reaching 10,000 steps per day. Participants were also recommended to walk at a brisk pace for 3000 of these steps, which roughly translates to 30 minutes per day. | Behavioural | Control, Phone Messaging, Phone Messaging + Family/Friend Support |
| Phone MessagingParticipants received short text or voice messages (depending on participant preference) as reminders to review daily step goals and to self-monitor; explaining the benefits of regular physical activity, importance of regular physical activity to daily life, and ways to overcome commonly identified barriers to physical activity; asking participants to report on their physical activity performance; providing feedback based on responses. | Behavioural | Phone Messaging, Phone Messaging + Family/Friend Support |
| Family/Friend SupportParticipants identified a family member or close friend (FF) to receive short text or voice messages (depending on FF preference) with suggested behaviors that are perceived as supportive by individuals making physical activity behavior changes. | Behavioural | Phone Messaging + Family/Friend Support |
Primary outcome
Change in average daily steps assessed by pedometers
Time frame: Baseline, 6 weeks, 12 weeks
Change in average daily steps assessed using pedometer 7-day data storage
4 secondary outcomes
Change in body mass index
Time frame: Baseline, 6 weeks, 12 weeks
Change in exercise self-efficacy assessed using the Exercise Self-Efficacy Scale
Time frame: Baseline, 6 weeks, 12 weeks
Change in barriers self-efficacy assessed using the Barriers Self-Efficacy Scale
Time frame: Baseline, 6 weeks, 12 weeks
Change in perceived family/friend social support assessed using the Social Support and Exercise Survey
Time frame: Baseline, 6 weeks, 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 13 Mar 2017.
- Derived from this study: PubMed 30291094Ramirez M, Wu S. Phone Messaging to Prompt Physical Activity and Social Support Among Low-Income Latino Patients With Type 2 Diabetes: A Randomized Pilot Study. JMIR Diabetes. 2017 Jun 6;2(1):e8. doi: 10.2196/diabetes.7063.
- Individual participant dataSharing planned: Undecided
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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.
Shinyi Wu, Ph.D. principal investigator
University of Southern California
Questions about this trial
What is this clinical trial studying?
A study testing Pedometers and Walking Logs, Phone Messaging and Family/Friend Support in people with Physical Activity, run by University of Southern California.
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 8 inclusion and 1 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 13 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 average daily steps assessed by pedometers (time frame: Baseline, 6 weeks, 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 NCT02850770, 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 13 Mar 2017.