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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
26
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
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
The University of Texas Health Science Center at Houston
Houston, Texas, United States
Change in Weight as assessed by the Tanita Scale
Time frame: baseline, 3 months, 6 months
Change in Glycemic control as assessed by HbA1c levels
Time frame: baseline, 3 months, 6 months
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
Change in Physical Activity as assessed by accelerometer
Time frame: baseline, 3 months, 6 months
Change in Physical Activity as assessed by IPAQ-Short Form
Time frame: baseline, 3 months, 6 months
Change in Blood pressure as assessed by automated blood pressure cuff
Time frame: baseline, 3 months, 6 months
Change in Waist circumference
Time frame: baseline, 3 months, 6 months
Change in Inflammation as assessed by C-reactive protein levels
Time frame: baseline, 3 months, 6 months
Change in Inflammation as assessed by IL-6 levels
Time frame: baseline, 3 months, 6 months
Percent attendance at group sessions
Time frame: 6 months
Percent adherence to self-monitoring
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Time frame: 6 months
Change in Health literacy as measured by the Newest Vital Sign health literacy assessment
Time frame: baseline, 3 months, 6 months
Change in Medication Adherence as assessed by the Morisky medication adherence questionnaire
Time frame: 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
Change in Diabetes Self-Care as Assessed by the Summary of Diabetes Self-Care Activities Expanded Version
Time frame: baseline, 3 months, 6 months
Change in Quality of life as assessed by the PROMIS Global
Time frame: baseline, 3 months, 6 months
Change in Clinical utility as assessed by the PROMIS 57
Time frame: baseline, 3 months, 6 months
Change in Perceived Stress as measured by the Perceived Stress Scale
Time frame: baseline, 3 months, 6 months
Change in Sleep Quality as assessed by the Pittsburgh Sleep Quality Index
Time frame: baseline, 3 months, 6 months
Change in Sleepiness. Assessed by the Epworth Sleepiness Scale
Time frame: 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