Diabetes Go Mobile! Pilot Study

The University of Texas System (UT)

Status: Completed

Conditions: Diabetes

Treatments: Behavioral: Behavior intervention with paper diary based self-monitoring; Behavioral: Behavior intervention with smart phone based self-monitoring

Study type: Interventional

Funder types: Other

Identifiers

NCT02858648

HSC-SN-12-0582

Details and patient eligibility

About

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.

Full 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.

Enrollment: 26 patients

Sex: All

Ages: 21 to 74 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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26 participants in 3 patient groups

Behavior intervention with smart phone based self-monitoring

Experimental group

Description:

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.

Treatment:

Behavioral: Behavior intervention with smart phone based self-monitoring

Behavior intervention with paper diary based self-monitoring

Experimental group

Description:

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.

Treatment:

Behavioral: Behavior intervention with paper diary based self-monitoring

Usual care

No Intervention group

Description:

Patients in this group received no intervention, they continue to receive usual diabetes care and education from the recruitment clinic.