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Completed

NCT Number: NCT01579292

A Mobile Based Diabetes Prevention Program

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.

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Key information

Conditions

Sedentary Lifestyle Behavior Glucose Intolerance Glucose Metabolism Disorders Hyperglycemia Metabolic Diseases Motor Activity Nutritional and Metabolic Diseases Physical Activity Pre-diabetic Sedentary Behavior

Age range

35 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California San Francisco

San Francisco, California, 94118, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mobile phone based physical activity with intervention

Behavioral

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

Behavioral

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

Primary outcomes

  1. Body weight (kg)

    Time frame: 5 months

  2. Body mass index

    Time frame: 5 months

Secondary outcomes

  1. Physical activity measured by Omron Active Style Pro HJA-350IT pedometer

    Time frame: 5 months

  2. Total daily calories (kcal)

    Time frame: 5 months

  3. Daily calories from fat (kcal)

    Time frame: 5 months

  4. Fasting plasma glucose

    Time frame: 5 months

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Apr 17, 2012
Registry last updated
Jul 17, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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