Diabetes Go Mobile! Pilot Study

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02858648
• Other study ID #: HSC-SN-12-0582
• Status: Completed
• Phase: N/A
• First received: August 2, 2016
• Last updated: August 5, 2016
• Start date: January 2013
• Est. completion date: August 2013

Study information

• Verified date: August 2016
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 74 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus

Intervention

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
• 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

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	Harris Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Weight as assessed by the Tanita Scale		baseline, 3 months, 6 months	No
Primary	Change in Glycemic control as assessed by HbA1c levels		baseline, 3 months, 6 months	No
Secondary	Change in Dietary intake as measured by the Automated Self-administered 24-hour Dietary Recall (ASA24™) version 1		baseline, 3 months, 6 months	No
Secondary	Change in Physical Activity as assessed by accelerometer		baseline, 3 months, 6 months	No
Secondary	Change in Physical Activity as assessed by IPAQ-Short Form		baseline, 3 months, 6 months	No
Secondary	Change in Blood pressure as assessed by automated blood pressure cuff		baseline, 3 months, 6 months	No
Secondary	Change in Waist circumference		baseline, 3 months, 6 months	No
Secondary	Change in Inflammation as assessed by C-reactive protein levels		baseline, 3 months, 6 months	No
Secondary	Change in Inflammation as assessed by IL-6 levels		baseline, 3 months, 6 months	No
Secondary	Percent attendance at group sessions		6 months	No
Secondary	Percent adherence to self-monitoring		6 months	No
Secondary	Change in Health literacy as measured by the Newest Vital Sign health literacy assessment		baseline, 3 months, 6 months	No
Secondary	Change in Medication Adherence as assessed by the Morisky medication adherence questionnaire		baseline, 3 months, 6 months	No
Secondary	Change in Depression as measured by the Center for Epidemiologic Studies Depression Scale (CES-D)		baseline, 3 months, 6 months	No
Secondary	Change in Diabetes Self-Care as Assessed by the Summary of Diabetes Self-Care Activities Expanded Version		baseline, 3 months, 6 months	No
Secondary	Change in Quality of life as assessed by the PROMIS Global		baseline, 3 months, 6 months	No
Secondary	Change in Clinical utility as assessed by the PROMIS 57		baseline, 3 months, 6 months	No
Secondary	Change in Perceived Stress as measured by the Perceived Stress Scale		baseline, 3 months, 6 months	No
Secondary	Change in Sleep Quality as assessed by the Pittsburgh Sleep Quality Index		baseline, 3 months, 6 months	No
Secondary	Change in Sleepiness. Assessed by the Epworth Sleepiness Scale		baseline, 3 months, 6 months	No
Secondary	Change in Self-efficacy for diabetes as assessed by the Self-efficacy for diabetes measure		baseline, 3 months, 6 months	No