A Mobile Based Diabetes Prevention Program

Physical Activity Clinical Trial

Official title:

mDPP Pilot RCT of a Motivational Mobile Diabetes Prevention Program (mDPP)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01579292
• Other study ID #: 1107481
• Status: Completed
• Phase: N/A
• First received: April 15, 2012
• Last updated: July 16, 2014
• Start date: May 2012
• Est. completion date: July 2013

Study information

• Verified date: July 2014
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 35 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Physical Activity
• Pre-Diabetic
• Prediabetic State
• Sedentary Lifestyle

Intervention

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

Locations

Country	Name	City	State
United States	University of California San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body weight (kg)		5 months	No
Primary	Body mass index		5 months	No
Secondary	Physical activity measured by Omron Active Style Pro HJA-350IT pedometer		5 months	No
Secondary	Total daily calories (kcal)		5 months	No
Secondary	Daily calories from fat (kcal)		5 months	No
Secondary	Fasting plasma glucose		5 months	No