A Mobile Based Diabetes Prevention Program

NCT ID: NCT01579292

Last Updated: 2014-07-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2013-07-31

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.

Conditions

Sedentary Lifestyle; Physical Activity; Pre-Diabetic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Physical Activity and Diet Intervention

5-month physical activity and diet intervention which includes 6 in-person sessions, mobile app, and pedometer

Group Type: EXPERIMENTAL

Mobile phone based physical activity with intervention

Intervention Type: BEHAVIORAL

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.

Pedometer only

Pedometer only

Group Type: ACTIVE_COMPARATOR

Pedometer Only

Intervention Type: BEHAVIORAL

This group will receive a pedometer. Over a 5-month period, participants in this group will be asked to wear a pedometer.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yoshimi Fukuoka, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

University of California San Francisco

San Francisco, California, United States

Countries

United States

Other Identifiers

1107481

Identifier Type: -

Identifier Source: org_study_id