A Mobile Based Diabetes Prevention Program
|ClinicalTrials.gov Identifier: NCT01579292|
Recruitment Status : Completed
First Posted : April 17, 2012
Last Update Posted : July 17, 2014
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.
|Condition or disease||Intervention/treatment|
|Sedentary Lifestyle Physical Activity Pre-Diabetic||Behavioral: Mobile phone based physical activity with intervention Behavioral: Pedometer Only|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||61 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||mDPP Pilot RCT of a Motivational Mobile Diabetes Prevention Program (mDPP)|
|Study Start Date :||May 2012|
|Primary Completion Date :||July 2013|
|Study Completion Date :||July 2013|
Experimental: Physical Activity and Diet Intervention
5-month physical activity and diet intervention which includes 6 in-person sessions, mobile app, and pedometer
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.
Active Comparator: Pedometer only
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.
- Body weight (kg) [ Time Frame: 5 months ]
- Body mass index [ Time Frame: 5 months ]
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01579292
|United States, California|
|University of California San Francisco|
|San Francisco, California, United States, 94118|
|Principal Investigator:||Yoshimi Fukuoka, Ph.D.||University of California, San Francisco|