Diabetes Go Mobile! Pilot Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Diabetes

Intervention / Treatment
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* Behavioral: Behavior intervention with smart phone based self-monitoring
* Behavioral: Behavior intervention with paper diary based self-monitoring


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Behavior intervention with smart phone based self-monitoring<br>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<br>* 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<br>|
| Experimental: Behavior intervention with paper diary based self-monitoring<br>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<br>* 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<br>|
| No Intervention: Usual care<br>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?
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Primary Outcome Measures

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

Secondary Outcome Measures

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