Clinical trial NCT02850770: Physical Activity and Social Support Prompting Via Phone Messaging
Official title: Phone Messaging for Physical Activity and Social Support Prompting Among Low-Income Latino Patients: A Randomized Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
name: Los Angeles County Department of Public Health
First posted: 2016-08-01
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Pregnant or breastfeeding women

Primary outcomes:
measure: Change in average daily steps assessed by pedometers
timeFrame: Baseline, 6 weeks, 12 weeks
Secondary outcomes:
measure: Change in body mass index
timeFrame: Baseline, 6 weeks, 12 weeks
measure: Change in exercise self-efficacy assessed using the Exercise Self-Efficacy Scale
timeFrame: Baseline, 6 weeks, 12 weeks
measure: Change in barriers self-efficacy assessed using the Barriers Self-Efficacy Scale
timeFrame: Baseline, 6 weeks, 12 weeks
measure: Change in perceived family/friend social support assessed using the Social Support and Exercise Survey
timeFrame: Baseline, 6 weeks, 12 weeks
Other outcomes:
measure: Change in perceived usefulness assessed using patient interviews
timeFrame: 6 weeks, 12 weeks
measure: Change in perceived usability of pedometers assessed via patient interviews
timeFrame: Baseline, 6 weeks, 12 weeks
measure: Change in perceived barriers to receipt of and engagement with ST/VMs assessed via patient interviews
timeFrame: 6 weeks, 12 weeks
measure: Change in engagement with ST/VMs requiring a response assessed via call logs
timeFrame: 6 weeks, 12 weeks
measure: Change in receipt of ST/VMs assessed via self-report and call logs
timeFrame: 6 weeks, 12 weeks
measure: Change in non-compliance with wearing pedometer assessed via pedometer and walking log
timeFrame: Baseline, 6 weeks, 12 weeks
measure: Recruitment and retention rates assessed via recruitment and follow-up logs
timeFrame: 1 day (Recruitment), 6 weeks, 12 weeks
measure: Sufficiency or restrictiveness of eligibility criteria assessed via recruitment logs
timeFrame: 1 day (Recruitment)
Locations:
Study officials:
affiliation: University of Southern California
name: Shinyi Wu, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.