Diabetes Go Mobile! Pilot Study

NCT ID: NCT02858648

Last Updated: 2016-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2013-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Behavior intervention with smart phone based self-monitoring

Intervention Type 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 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.

Group Type EXPERIMENTAL

Behavior intervention with paper diary based self-monitoring

Intervention Type 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

Usual care

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Behavior intervention with smart phone based self-monitoring

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

Intervention Type BEHAVIORAL

Behavior intervention with paper diary based self-monitoring

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Harris Health System

UNKNOWN

Sponsor Role collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Jing Wang

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jing Wang, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

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The University of Texas Health Science Center at Houston

Houston, Texas, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 32706652 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29636320 (View on PubMed)

Other Identifiers

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HSC-SN-12-0582

Identifier Type: -

Identifier Source: org_study_id

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