A Mobile Based Diabetes Prevention Program

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01579292
Recruitment Status : Completed
First Posted : April 17, 2012
Last Update Posted : July 17, 2014
Information provided by (Responsible Party):
University of California, San Francisco

April 15, 2012
April 17, 2012
July 17, 2014
May 2012
July 2013   (Final data collection date for primary outcome measure)
  • Body weight (kg) [ Time Frame: 5 months ]
  • Body mass index [ Time Frame: 5 months ]
Physical activity measured by Omron Active Style Pro HJA-350IT [ Time Frame: 5 months ]
Complete list of historical versions of study NCT01579292 on Archive Site
  • Physical activity measured by Omron Active Style Pro HJA-350IT pedometer [ Time Frame: 5 months ]
  • Total daily calories (kcal) [ Time Frame: 5 months ]
  • Daily calories from fat (kcal) [ Time Frame: 5 months ]
  • Fasting plasma glucose [ Time Frame: 5 months ]
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A Mobile Based Diabetes Prevention Program
mDPP Pilot RCT of a Motivational Mobile Diabetes Prevention Program (mDPP)

The goals of the study are to:

  1. 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.
  2. To explore the association between low heath-literacy levels at baseline and adherence to mobile phone usage.
  3. 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.

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.

Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
  • Sedentary Lifestyle
  • Physical Activity
  • Pre-Diabetic
  • Behavioral: Mobile phone based physical activity with intervention
    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.
  • Behavioral: Pedometer Only
    This group will receive a pedometer. Over a 5-month period, participants in this group will be asked to wear a pedometer.
  • Experimental: Physical Activity and Diet Intervention
    5-month physical activity and diet intervention which includes 6 in-person sessions, mobile app, and pedometer
    Intervention: Behavioral: Mobile phone based physical activity with intervention
  • Active Comparator: Pedometer only
    Pedometer only
    Intervention: Behavioral: Pedometer Only
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
July 2013
July 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
35 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
University of California, San Francisco
University of California, San Francisco
Not Provided
Principal Investigator: Yoshimi Fukuoka, Ph.D. University of California, San Francisco
University of California, San Francisco
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP