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A Mobile Based Diabetes Prevention Program

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01579292
First received: April 15, 2012
Last updated: July 16, 2014
Last verified: July 2014
  Purpose

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.

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: Open Label
Primary Purpose: Prevention
Official Title: mDPP Pilot RCT of a Motivational Mobile Diabetes Prevention Program (mDPP)

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Body weight (kg) [ Time Frame: 5 months ] [ Designated as safety issue: No ]
  • Body mass index [ Time Frame: 5 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Physical activity measured by Omron Active Style Pro HJA-350IT pedometer [ Time Frame: 5 months ] [ Designated as safety issue: No ]
  • Total daily calories (kcal) [ Time Frame: 5 months ] [ Designated as safety issue: No ]
  • Daily calories from fat (kcal) [ Time Frame: 5 months ] [ Designated as safety issue: No ]
  • Fasting plasma glucose [ Time Frame: 5 months ] [ Designated as safety issue: No ]

Enrollment: 61
Study Start Date: May 2012
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Physical Activity and Diet Intervention
5-month physical activity and diet intervention which includes 6 in-person sessions, mobile app, and pedometer
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.
Active Comparator: Pedometer only
Pedometer only
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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01579292

Locations
United States, California
University of California San Francisco
San Francisco, California, United States, 94118
Sponsors and Collaborators
University of California, San Francisco
Investigators
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: July 16, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Prediabetic State
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on November 27, 2014