- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01579292
A Mobile Based Diabetes Prevention Program
mDPP Pilot RCT of a Motivational Mobile Diabetes Prevention Program (mDPP)
The goals of the study are to:
- Assess effect sizes of our mDPP intervention on weight loss, physical activity, dietary intake, and fasting plasma glucose (FPG) levels from baseline to 5 months as compared to a control group.
- To explore the association between low heath-literacy levels at baseline and adherence to mobile phone usage.
- To conduct process evaluation to gain insights into patient compliance to the mobile intervention, including usage barriers and acceptability of our mDPP, at 1 and 5 months using a semi-structured interview method.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The prevalence of type 2 diabetes (T2DM) continues to rise at an alarming rate in the United States. A greater risk of diabetes is observed for ethnic/racial minority and lower socioeconomic status (SES)groups as compared to Caucasians of similar ages. Several clinical trials have tested intensive lifestyle interventions or pharmacologic agents in preventing or delaying T2DM in adults at risk. These trials (e.g.the Diabetes Prevention Program) consistently show impressive diabetes risk reductions using lifestyle interventions, such as relatively modest amounts of weight loss and exercise. However these programs have been expensive to implement and sustain over time in clinical settings or communities.
Mobile technologies are ideal platforms to deliver and disseminate such lifestyle modification programs to a much broader ethnic/racial minority population, making them more cost effective. Today, 87% of adults in the U.S. own a mobile phone. In particular, usage of non-voice services (such as text messaging or mobile internet) in African-Americans and non-white Hispanics is significantly higher than their Caucasian counterparts. In contrast, ethnic /racial minority populations are much less likely to own a computer at home compared to their Caucasian counterparts. Given the rapid diffusion of mobile technologies in ethnic/racial minority populations, we need to understand how to apply mobile persuasive technologies to such lifestyle modification programs.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
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San Francisco, California, United States, 94118
- University of California San Francisco
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Sedentary lifestyle at work and/or during leisure time
- Intend to be physically active
- Are over 25 years of age
- Access to a home telephone or a mobile phone
- Speak and read English
- Are not physically active
- Have no disabilities that limit physical activity
- Have high blood sugar (fasting blood sugar 100-125) but do not have diabetes
Exclusion Criteria:
- Known medical conditions or other physical problems that need special attention in an exercise program
- Plan a trip abroad during the first 5 months of the study period.
- Pregnant/Delivered a baby during the last 6 months
- Known severe hearing or speech problem
- Currently participate in lifestyle modification programs or research studies that may potentially confound the results of the study
- History of gastric bypass surgery or future plans for gastric bypass surgery in the next 5 months
- Already taking medication for diabetes
- Recovery from addiction
- Known eating disorders
- Bmi over 25 if non-Asian or over 23 if Asian
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Physical Activity and Diet Intervention
5-month physical activity and diet intervention which includes 6 in-person sessions, mobile app, and pedometer
|
This group will receive a mobile phone software program and a pedometer.
Over a 5-month period, participants in this group will be asked to participate in 6 in-person sessions, wear a pedometer, use a mobile phone physical activity and diet diary, and respond to daily physical activity and diet messages or video clips.
|
Active Comparator: Pedometer only
|
This group will receive a pedometer.
Over a 5-month period, participants in this group will be asked to wear a pedometer.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Body weight (kg)
Time Frame: 5 months
|
5 months
|
Body mass index
Time Frame: 5 months
|
5 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Physical activity measured by Omron Active Style Pro HJA-350IT pedometer
Time Frame: 5 months
|
5 months
|
Total daily calories (kcal)
Time Frame: 5 months
|
5 months
|
Daily calories from fat (kcal)
Time Frame: 5 months
|
5 months
|
Fasting plasma glucose
Time Frame: 5 months
|
5 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Yoshimi Fukuoka, Ph.D., University of California, San Francisco
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1107481
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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