NCT02850770

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2015

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 12, 2016

Completed
4 months until next milestone

First Posted

Study publicly available on registry

August 1, 2016

Completed
Last Updated

March 13, 2017

Status Verified

March 1, 2017

Enrollment Period

7 months

First QC Date

April 12, 2016

Last Update Submit

March 8, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Change in body mass index

    Baseline, 6 weeks, 12 weeks

  • 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

    Baseline, 6 weeks, 12 weeks

  • Change in perceived family/friend social support assessed using the Social Support and Exercise Survey

    Baseline, 6 weeks, 12 weeks

Other Outcomes (8)

  • Change in perceived usefulness assessed using patient interviews

    6 weeks, 12 weeks

  • Change in perceived usability of pedometers assessed via patient interviews

    Baseline, 6 weeks, 12 weeks

  • Change in perceived barriers to receipt of and engagement with ST/VMs assessed via patient interviews

    6 weeks, 12 weeks

  • +5 more other outcomes

Study Arms (3)

Control

OTHER

Pedometers and walking logs

Behavioral: Pedometers and Walking Logs

Phone Messaging

EXPERIMENTAL

Phone Messaging

Behavioral: Pedometers and Walking LogsBehavioral: Phone Messaging

Phone Messaging + Family/Friend Support

EXPERIMENTAL

Phone Messaging + Family/Friend Support

Behavioral: Pedometers and Walking LogsBehavioral: Phone MessagingBehavioral: Family/Friend Support

Interventions

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.

ControlPhone MessagingPhone Messaging + Family/Friend Support
Phone MessagingBEHAVIORAL

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.

Phone MessagingPhone Messaging + 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.

Phone Messaging + Family/Friend Support

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Pregnant or breastfeeding women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Shinyi Wu, Ph.D.

    University of Southern California

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 12, 2016

First Posted

August 1, 2016

Study Start

April 1, 2015

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

March 13, 2017

Record last verified: 2017-03