Physical Activity and Social Support Prompting Via Phone Messaging

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.

Study Overview

• Status: Completed
• Conditions: Physical Activity
• Intervention / Treatment: Behavioral: Pedometers and Walking Logs; Behavioral: Phone Messaging; Behavioral: Family/Friend Support

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 Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Control; Pedometers and walking logs	Behavioral: Pedometers and Walking Logs; 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.
Experimental: Phone Messaging	Behavioral: Pedometers and Walking Logs; 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.; Behavioral: Phone Messaging; 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.
Experimental: Phone Messaging + Family/Friend Support	Behavioral: Pedometers and Walking Logs; 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.; Behavioral: Phone Messaging; 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.; Behavioral: Family/Friend Support; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in average daily steps assessed by pedometers	Change in average daily steps assessed using pedometer 7-day data storage	Baseline, 6 weeks, 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in body mass index	Change in Body Mass Index, which was calculated as weight (in kilograms) over height squared (in centimeters)	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	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	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	Baseline, 6 weeks, 12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in perceived usefulness assessed using patient interviews	At the 6- and 12-week follow-up interviews, participants were asked a series of unstructured questions regarding the extent to which the program enhanced a participant's ability to make physical activity behavior changes. These questions inquired about participants' thoughts on setting PA goals, self-monitoring, educational and feedback ST/VMs, and the idea of using ST/VMs to communicate with patients about PA behavior change. For participants in the PM+FF arms, the questions also inquired about supportive behaviors exhibited by FF since the start of the program and participants' thoughts on the idea of using ST/VMs to communicate with FF about patients' PA behavior changes. Investigators also asked if participants would be willing to participate in a similar program in the future and if participants would be willing to recommend the program to other patients. The latter two were yes/no questions.	6 weeks, 12 weeks
Change in perceived usability of pedometers assessed via patient interviews	Semi-structured patient interview questions inquiring about the degree to which participants perceived the pedometers to be easy to use	Baseline, 6 weeks, 12 weeks
Change in perceived barriers to receipt of and engagement with ST/VMs assessed via patient interviews	Semi-structured patient interview questions inquiring about participants' perceived barriers to the receipt of and engagement with ST/VMs	6 weeks, 12 weeks
Change in engagement with ST/VMs requiring a response assessed via call logs	Percentage of times that participants responded to ST/VMs requiring a response	6 weeks, 12 weeks
Change in receipt of ST/VMs assessed via self-report and call logs	Percentage of short text messages delivered that were received assessed via self-report, and percentage of voice messages that were received assessed via call logs	6 weeks, 12 weeks
Change in non-compliance with wearing pedometer assessed via pedometer and walking log	Percentage of patients that did not wear the pedometer for a minimum of three consecutive days for at least 10 hours per day. This data will be obtained using the pedometer 7-day memory storage and participants' self-reported hours of use.	Baseline, 6 weeks, 12 weeks
Recruitment and retention rates assessed via recruitment and follow-up logs	Percentage of patients that were screened, were eligible to participate, and enrolled in the study. Percentage of patients who completed the 6-week and 12-week follow-up assessments.	1 day (Recruitment), 6 weeks, 12 weeks
Sufficiency or restrictiveness of eligibility criteria assessed via recruitment logs	Percentage of patients that were screened, but were ineligible to participate and the reasons why	1 day (Recruitment)

Collaborators and Investigators

• Sponsor: University of Southern California
• Collaborators: National Institute of Neurological Disorders and Stroke (NINDS); Los Angeles County Department of Public Health
• Investigators: Principal Investigator: Shinyi Wu, Ph.D., University of Southern California

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: April 12, 2016
• First Submitted That Met QC Criteria: July 29, 2016
• First Posted (Estimate): August 1, 2016

Study Record Updates

• Last Update Posted (Actual): March 13, 2017
• Last Update Submitted That Met QC Criteria: March 8, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: HS-13-00471; 3U54NS081764-03S1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED