Clinical trial NCT02858648: Diabetes Go Mobile! Pilot Study
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: Harris Health System
First posted: 2016-08-08
Enrollment: 26
Sex: ALL
Minimum age (years): 21
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Weight as assessed by the Tanita Scale
timeFrame: baseline, 3 months, 6 months
measure: Change in Glycemic control as assessed by HbA1c levels
timeFrame: baseline, 3 months, 6 months
Secondary outcomes:
measure: Change in Dietary intake as measured by the Automated Self-administered 24-hour Dietary Recall (ASA24™) version 1
timeFrame: baseline, 3 months, 6 months
measure: Change in Physical Activity as assessed by accelerometer
timeFrame: baseline, 3 months, 6 months
measure: Change in Physical Activity as assessed by IPAQ-Short Form
timeFrame: baseline, 3 months, 6 months
measure: Change in Blood pressure as assessed by automated blood pressure cuff
timeFrame: baseline, 3 months, 6 months
measure: Change in Waist circumference
timeFrame: baseline, 3 months, 6 months
measure: Change in Inflammation as assessed by C-reactive protein levels
timeFrame: baseline, 3 months, 6 months
measure: Change in Inflammation as assessed by IL-6 levels
timeFrame: baseline, 3 months, 6 months
measure: Percent attendance at group sessions
timeFrame: 6 months
measure: Percent adherence to self-monitoring
timeFrame: 6 months
measure: Change in Health literacy as measured by the Newest Vital Sign health literacy assessment
timeFrame: baseline, 3 months, 6 months
measure: Change in Medication Adherence as assessed by the Morisky medication adherence questionnaire
timeFrame: baseline, 3 months, 6 months
measure: Change in Depression as measured by the Center for Epidemiologic Studies Depression Scale (CES-D)
timeFrame: baseline, 3 months, 6 months
measure: Change in Diabetes Self-Care as Assessed by the Summary of Diabetes Self-Care Activities Expanded Version
timeFrame: baseline, 3 months, 6 months
measure: Change in Quality of life as assessed by the PROMIS Global
timeFrame: baseline, 3 months, 6 months
measure: Change in Clinical utility as assessed by the PROMIS 57
timeFrame: baseline, 3 months, 6 months
measure: Change in Perceived Stress as measured by the Perceived Stress Scale
timeFrame: baseline, 3 months, 6 months
measure: Change in Sleep Quality as assessed by the Pittsburgh Sleep Quality Index
timeFrame: baseline, 3 months, 6 months
measure: Change in Sleepiness. Assessed by the Epworth Sleepiness Scale
timeFrame: baseline, 3 months, 6 months
measure: Change in Self-efficacy for diabetes as assessed by the Self-efficacy for diabetes measure
timeFrame: baseline, 3 months, 6 months
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Jing Wang, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.