Diabetes Go Mobile! Pilot Study

NCT02858648 | Completed

• 1 other identifier: HSC-SN-12-0582
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (19)

• 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

Study Arms (3)

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.

Behavioral: Behavior intervention with smart phone based self-monitoring

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.

Behavioral: Behavior intervention with paper diary based self-monitoring

Usual care

NO INTERVENTION

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

Interventions

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

Behavior intervention with smart phone based self-monitoring

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

Behavior intervention with paper diary based self-monitoring

Eligibility Criteria

• Age: 21 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• Harris Health System: collaborator

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Related Publications (2)

• 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.

  PMID: 32706652 DERIVED

• 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.

  PMID: 29636320 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Jing Wang, PhD, MPH

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 2, 2016
• First Posted: August 8, 2016
• Study Start: January 1, 2013
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: August 8, 2016

Record last verified: 2016-08

Locations

US (1)