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| Name | Class |
|---|---|
| Harris Health System | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Behavior intervention with smart phone based self-monitoring | Experimental | 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. |
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| Behavior intervention with paper diary based self-monitoring | Experimental | 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. |
|
| Usual care | No Intervention | Patients in this group received no intervention, they continue to receive usual diabetes care and education from the recruitment clinic. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavior intervention with smart phone based self-monitoring | Behavioral | 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Dietary intake as measured by the Automated Self-administered 24-hour Dietary Recall (ASA24â„¢) version 1 | baseline, 3 months, 6 months | |
| Change in Physical Activity as assessed by accelerometer | baseline, 3 months, 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jing Wang, PhD, MPH | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32706652 | Derived | Jiwani R, Wang J, Berndt A, Ramaswamy P, Mathew Joseph N, Du Y, Ko J, Espinoza S. Changes in Patient-Reported Outcome Measures With a Technology-Supported Behavioral Lifestyle Intervention Among Patients With Type 2 Diabetes: Pilot Randomized Controlled Clinical Trial. JMIR Diabetes. 2020 Jul 24;5(3):e19268. doi: 10.2196/19268. | |
| 29636320 |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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|
| Behavior intervention with paper diary based self-monitoring | Behavioral | 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 |
|
| 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 |
| Wang J, Cai C, Padhye N, Orlander P, Zare M. A Behavioral Lifestyle Intervention Enhanced With Multiple-Behavior Self-Monitoring Using Mobile and Connected Tools for Underserved Individuals With Type 2 Diabetes and Comorbid Overweight or Obesity: Pilot Comparative Effectiveness Trial. JMIR Mhealth Uhealth. 2018 Apr 10;6(4):e92. doi: 10.2196/mhealth.4478. |