Sedentary LifestyleNCT01579292
A Mobile Based Diabetes Prevention Program
A study testing Mobile phone based physical activity with intervention and Pedometer Only in people with Sedentary Lifestyle and Physical Activity, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sedentary Lifestyle, Physical Activity, Pre-Diabetic
- What is being tested?
- Mobile phone based physical activity with intervention and Pedometer Only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Jul 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- Already taking medication for diabetes
- Recovery from addiction
- Known eating disorders
- Bmi over 25 if non-Asian or over 23 if Asian
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Francisco
San Francisco, California, 94118
About this study
Official title: mDPP Pilot RCT of a Motivational Mobile Diabetes Prevention Program (mDPP)
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.
Read the 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.
- Conditions
- Sedentary Lifestyle, Physical Activity, Pre-Diabetic
- Being tested
- Mobile phone based physical activity with intervention, Pedometer Only
- Medical subject headings
- Sedentary Behavior, Motor Activity, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile phone based physical activity with interventionBehavioural
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 OnlyBehavioural
This group will receive a pedometer. Over a 5-month period, participants in this group will be asked to wear a pedometer.
| Study group | Role | What they receive |
|---|---|---|
| Physical Activity and Diet Intervention | Experimental | 5-month physical activity and diet intervention which includes 6 in-person sessions, mobile app, and pedometer Receives: Behavioral: Mobile phone based physical activity with intervention |
| Pedometer only | Active comparator | Pedometer only Receives: Behavioral: Pedometer Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight (kg)
Measured: 5 months
Body mass index
Measured: 5 months
Secondary outcomes (4)
Physical activity measured by Omron Active Style Pro HJA-350IT pedometer
Measured: 5 months
Total daily calories (kcal)
Measured: 5 months
Daily calories from fat (kcal)
Measured: 5 months
Fasting plasma glucose
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2012 (estimated)
- Study startMay 2012
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedentary LifestyleStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yoshimi Fukuoka, Ph.D., Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01579292
- Sponsor's protocol ID
- 1107481
- Status last verified
- Jul 2014
- First submitted
- 15 Apr 2012
- Last updated
- 17 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- mDPP Pilot RCT of a Motivational Mobile Diabetes Prevention Program (mDPP)
- ClinicalTrials.gov ID
- NCT01579292
- Acronym / sponsor ID
- 1107481
- Conditions
- Sedentary Lifestyle, Physical Activity, Pre-Diabetic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 17 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical Activity and Diet Intervention | Experimental | Behavioral: Mobile phone based physical activity with intervention5-month physical activity and diet intervention which includes 6 in-person sessions, mobile app, and pedometer |
| Pedometer only | Active comparator | Behavioral: Pedometer OnlyPedometer only |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile phone based physical activity with interventionThis 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. | Behavioural | Physical Activity and Diet Intervention |
| Pedometer OnlyThis group will receive a pedometer. Over a 5-month period, participants in this group will be asked to wear a pedometer. | Behavioural | Pedometer only |
Primary outcome
Body weight (kg)
Time frame: 5 months
Body mass index
Time frame: 5 months
4 secondary outcomes
Physical activity measured by Omron Active Style Pro HJA-350IT pedometer
Time frame: 5 months
Total daily calories (kcal)
Time frame: 5 months
Daily calories from fat (kcal)
Time frame: 5 months
Fasting plasma glucose
Time frame: 5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yoshimi Fukuoka, Ph.D. principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile phone based physical activity with intervention and Pedometer Only in people with Sedentary Lifestyle and Physical Activity, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body weight (kg) (time frame: 5 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2014.