A Mobile Based Diabetes Prevention Program
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The goals of the study are to:
- Assess effect sizes of our mDPP intervention on improving fasting plasma glucose levels(FPG), weight loss, diet, and physical activity 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 | Intervention |
|---|---|
|
Sedentary Lifestyle Physical Activity Pre-Diabetic |
Behavioral: Mobile phone based physical activity with intervention Behavioral: Pedometer Only |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | mDPP Pilot RCT of a Motivational Mobile Diabetes Prevention Program (mDPP) |
- Physical activity measured by Omron Active Style Pro HJA-350IT [ Time Frame: 5 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 42 |
| Study Start Date: | April 2012 |
| Estimated Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: PA and Diet Intervention
5-month physical activity and diet intervention and 6-month maintenance intervention-Plus program
|
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 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
Non-intervention group
|
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.
|
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| Ages Eligible for Study: | 35 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Sedentary lifestyle at work and/or during leisure time
- Intend to be physically active
- Are over 35 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
Contacts and Locations| 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 |
More Information
No publications provided
| Responsible Party: | University of California, San Francisco |
| ClinicalTrials.gov Identifier: | NCT01579292 History of Changes |
| Other Study ID Numbers: | 1107481 |
| Study First Received: | April 15, 2012 |
| Last Updated: | April 29, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Prediabetic State Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013