Diabetes Go Mobile! Pilot Study
- Conditions
- Diabetes
- Interventions
- Behavioral: Behavior intervention with smart phone based self-monitoringBehavioral: Behavior intervention with paper diary based self-monitoring
- Registration Number
- NCT02858648
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 26
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Behavior intervention with smart phone based self-monitoring 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. Behavior intervention with paper diary based self-monitoring 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.
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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 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 Medication Adherence as assessed by the Morisky medication adherence questionnaire 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
Trial Locations
- Locations (1)
The University of Texas Health Science Center at Houston
🇺🇸Houston, Texas, United States