Diabetes Go Mobile! Pilot Study

August 5, 2016 updated by: Jing Wang, The University of Texas Health Science Center, Houston

Diabetes Go Mobile! - A Pilot Study Testing the Effect of a Behavioral Intervention With Smart Phone Based Self-Monitoring on Glycemic Control and Vascular Inflammatory Markers

The purpose of this study is to examine whether a behavioral lifestyle intervention using mobile smart phone technology for self-monitoring can lead to greater improvements in diabetes outcomes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The investigators will conduct a pilot randomized controlled clinical trial to examine the feasibility and preliminary efficacy of a behavioral lifestyle intervention on weight, glycemic control, and vascular inflammatory marker outcomes. A total of 26 overweight or obese patients with type 2 diabetes will be recruited from an underserved minority community health center in Houston, TX. They were randomly assigned into one of the three groups: 1) Behavior intervention with smart phone based self-monitoring, 2) Behavior intervention with paper diary based self-monitoring, and 3) Usual care group. Both Mobile and Paper groups received a total of 11 group sessions and 1 individual session in a 6-month intervention. Mobile group received an android-based smart phone with two applications loaded to help them record their diet, physical activity, weight, and blood glucose, while the paper group is using paper diaries for these recordings.

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • The University of Texas Health Science Center at Houston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 21 to 74 years of age
  • BMI≥ 25 kg/m2
  • Self-reported being diagnosed with type 2 diabetes for at least 6 months
  • Currently monitor blood glucose and has a blood glucose meter
  • Be able to read and write in English

Exclusion Criteria:

  • Previously participated in a structured lifestyle intervention, such as Look AHEAD in the last 12 months
  • Current pregnant /nursing or plan to become pregnant in the next 6 months
  • In addition to their diabetes condition, presence of a current serious illness or unstable condition requiring supervision on a special diet and limiting their ability to perform physical activity level.
  • Current treatment for a severe psychological disorder
  • Planned vacation, absences, or relocation in the next 6 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Behavior intervention with smart phone based self-monitoring
Patients in this group were asked to attend 11 group and 1 individual session over 6 months, and received a smartphone with two downloaded applications to monitor diet, physical activity, weight, and blood glucose (connected with a blue tooth glucometer) throughout 6 months.
Behavioral: Behavior intervention with smart phone based self-monitoring
Use two smartphone applications for self-monitoring of diet, physical activity, weight, and blood glucose (connected via a blue-tooth enabled glucometer), plus 11 group session and 1 individual session focused on behavioral strategies
Experimental: Behavior intervention with paper diary based self-monitoring
Patients in this group were asked to attend 11 group sessions and 1 individual session over 6 months, and received paper diaries along with a calorie counter booklet, weight scale, food scale, and pedometer to monitor diet, physical activity, weight, and blood glucose throughout 6 months.
Behavioral: Behavior intervention with paper diary based self-monitoring
Use paper diaries along with a calorie counter booklet, weight scale, food scale, and pedometer for self-monitoring of diet, physical activity, weight, and blood glucose, plus 11 group session and 1 individual session focused on behavioral strategies
No Intervention: Usual care
Patients in this group received no intervention, they continue to receive usual diabetes care and education from the recruitment clinic.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Weight as assessed by the Tanita Scale
Time Frame: baseline, 3 months, 6 months
baseline, 3 months, 6 months
Change in Glycemic control as assessed by HbA1c levels
Time Frame: baseline, 3 months, 6 months
baseline, 3 months, 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in Dietary intake as measured by the Automated Self-administered 24-hour Dietary Recall (ASA24™) version 1
Time Frame: baseline, 3 months, 6 months
baseline, 3 months, 6 months
Change in Physical Activity as assessed by accelerometer
Time Frame: baseline, 3 months, 6 months
baseline, 3 months, 6 months
Change in Physical Activity as assessed by IPAQ-Short Form
Time Frame: baseline, 3 months, 6 months
baseline, 3 months, 6 months
Change in Blood pressure as assessed by automated blood pressure cuff
Time Frame: baseline, 3 months, 6 months
baseline, 3 months, 6 months
Change in Waist circumference
Time Frame: baseline, 3 months, 6 months
baseline, 3 months, 6 months
Change in Inflammation as assessed by C-reactive protein levels
Time Frame: baseline, 3 months, 6 months
baseline, 3 months, 6 months
Change in Inflammation as assessed by IL-6 levels
Time Frame: baseline, 3 months, 6 months
baseline, 3 months, 6 months
Percent attendance at group sessions
Time Frame: 6 months
6 months
Percent adherence to self-monitoring
Time Frame: 6 months
6 months
Change in Health literacy as measured by the Newest Vital Sign health literacy assessment
Time Frame: baseline, 3 months, 6 months
baseline, 3 months, 6 months
Change in Medication Adherence as assessed by the Morisky medication adherence questionnaire
Time Frame: baseline, 3 months, 6 months
baseline, 3 months, 6 months
Change in Depression as measured by the Center for Epidemiologic Studies Depression Scale (CES-D)
Time Frame: baseline, 3 months, 6 months
baseline, 3 months, 6 months
Change in Diabetes Self-Care as Assessed by the Summary of Diabetes Self-Care Activities Expanded Version
Time Frame: baseline, 3 months, 6 months
baseline, 3 months, 6 months
Change in Quality of life as assessed by the PROMIS Global
Time Frame: baseline, 3 months, 6 months
baseline, 3 months, 6 months
Change in Clinical utility as assessed by the PROMIS 57
Time Frame: baseline, 3 months, 6 months
baseline, 3 months, 6 months
Change in Perceived Stress as measured by the Perceived Stress Scale
Time Frame: baseline, 3 months, 6 months
baseline, 3 months, 6 months
Change in Sleep Quality as assessed by the Pittsburgh Sleep Quality Index
Time Frame: baseline, 3 months, 6 months
baseline, 3 months, 6 months
Change in Sleepiness. Assessed by the Epworth Sleepiness Scale
Time Frame: baseline, 3 months, 6 months
baseline, 3 months, 6 months
Change in Self-efficacy for diabetes as assessed by the Self-efficacy for diabetes measure
Time Frame: baseline, 3 months, 6 months
baseline, 3 months, 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center, Houston

Collaborators

Harris Health System

Investigators

  • Principal Investigator: Jing Wang, PhD, MPH, The University of Texas Health Science Center, Houston

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

August 2, 2016

First Submitted That Met QC Criteria

August 5, 2016

First Posted (Estimate)

August 8, 2016

Study Record Updates

Last Update Posted (Estimate)

August 8, 2016

Last Update Submitted That Met QC Criteria

August 5, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSC-SN-12-0582

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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