A Mobile Based Diabetes Prevention Program

Not Applicable

Completed

• Conditions: Physical Activity; Sedentary Lifestyle; Pre-Diabetic
• Interventions: Behavioral: Pedometer Only; Behavioral: Mobile phone based physical activity with intervention

• Registration Number: NCT01579292
• Lead Sponsor: University of California, San Francisco

Brief Summary

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.

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 Timeline

• Study First Submitted: 2012-04-15
• Study First Submitted QC: 2012-04-16
• Study First Posted: 2012-04-17
• Study Start: 2012-05
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-16
• Last Update Posted: 2014-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pedometer only	Pedometer Only	Pedometer only
Physical Activity and Diet Intervention	Mobile phone based physical activity with intervention	5-month physical activity and diet intervention which includes 6 in-person sessions, mobile app, and pedometer

Primary Outcome Measures

Name	Time	Method
Body weight (kg)	5 months
Body mass index	5 months

Secondary Outcome Measures

Name	Time	Method
Daily calories from fat (kcal)	5 months
Fasting plasma glucose	5 months
Total daily calories (kcal)	5 months
Physical activity measured by Omron Active Style Pro HJA-350IT pedometer	5 months

Trial Locations

Locations (1)

University of California San Francisco; 🇺🇸 San Francisco, California, United States