A Mobile Based Diabetes Prevention Program
Primary Purpose
Sedentary Lifestyle, Physical Activity, Pre-Diabetic
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mobile phone based physical activity with intervention
Pedometer Only
Sponsored by
About this trial
This is an interventional prevention trial for Sedentary Lifestyle
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
Sites / Locations
- University of California San Francisco
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Physical Activity and Diet Intervention
Pedometer only
Arm Description
5-month physical activity and diet intervention which includes 6 in-person sessions, mobile app, and pedometer
Pedometer only
Outcomes
Primary Outcome Measures
Body weight (kg)
Body mass index
Secondary Outcome Measures
Physical activity measured by Omron Active Style Pro HJA-350IT pedometer
Total daily calories (kcal)
Daily calories from fat (kcal)
Fasting plasma glucose
Full Information
NCT ID
NCT01579292
First Posted
April 15, 2012
Last Updated
July 16, 2014
Sponsor
University of California, San Francisco
1. Study Identification
Unique Protocol Identification Number
NCT01579292
Brief Title
A Mobile Based Diabetes Prevention Program
Official Title
mDPP Pilot RCT of a Motivational Mobile Diabetes Prevention Program (mDPP)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The goals of the study are to:
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.
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sedentary Lifestyle, Physical Activity, Pre-Diabetic
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
61 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Physical Activity and Diet Intervention
Arm Type
Experimental
Arm Description
5-month physical activity and diet intervention which includes 6 in-person sessions, mobile app, and pedometer
Arm Title
Pedometer only
Arm Type
Active Comparator
Arm Description
Pedometer only
Intervention Type
Behavioral
Intervention Name(s)
Mobile phone based physical activity with intervention
Intervention Description
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
Intervention Name(s)
Pedometer Only
Intervention Description
This group will receive a pedometer. Over a 5-month period, participants in this group will be asked to wear a pedometer.
Primary Outcome Measure Information:
Title
Body weight (kg)
Time Frame
5 months
Title
Body mass index
Time Frame
5 months
Secondary Outcome Measure Information:
Title
Physical activity measured by Omron Active Style Pro HJA-350IT pedometer
Time Frame
5 months
Title
Total daily calories (kcal)
Time Frame
5 months
Title
Daily calories from fat (kcal)
Time Frame
5 months
Title
Fasting plasma glucose
Time Frame
5 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yoshimi Fukuoka, Ph.D.
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94118
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Mobile Based Diabetes Prevention Program
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