A Mobile Based Diabetes Prevention Program

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01579292
First received: April 15, 2012
Last updated: July 16, 2014
Last verified: July 2014

April 15, 2012
July 16, 2014
May 2012
July 2013   (final data collection date for primary outcome measure)
  • Body weight (kg) [ Time Frame: 5 months ] [ Designated as safety issue: No ]
  • Body mass index [ Time Frame: 5 months ] [ Designated as safety issue: No ]
Physical activity measured by Omron Active Style Pro HJA-350IT [ Time Frame: 5 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01579292 on ClinicalTrials.gov Archive Site
  • Physical activity measured by Omron Active Style Pro HJA-350IT pedometer [ Time Frame: 5 months ] [ Designated as safety issue: No ]
  • Total daily calories (kcal) [ Time Frame: 5 months ] [ Designated as safety issue: No ]
  • Daily calories from fat (kcal) [ Time Frame: 5 months ] [ Designated as safety issue: No ]
  • Fasting plasma glucose [ Time Frame: 5 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
61
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
Both
35 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01579292
1107481
Yes
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