Clinical trial NCT01579292: A Mobile Based Diabetes Prevention Program
Official title: mDPP Pilot RCT of a Motivational Mobile Diabetes Prevention Program (mDPP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sedentary Lifestyle
Physical Activity
Pre-Diabetic
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2012-04-17
Enrollment: 61
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Body weight (kg)
timeFrame: 5 months
measure: Body mass index
timeFrame: 5 months
Secondary outcomes:
measure: Physical activity measured by Omron Active Style Pro HJA-350IT pedometer
timeFrame: 5 months
measure: Total daily calories (kcal)
timeFrame: 5 months
measure: Daily calories from fat (kcal)
timeFrame: 5 months
measure: Fasting plasma glucose
timeFrame: 5 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Yoshimi Fukuoka, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: