Pre-diabetesProject NOT MENCT01768546
Evaluation of Video On-Demand Programming to Prevent Type 2 Diabetes in Adults
A study testing Virtual Diabetes Prevention Program and Interactive tracking and problem solving web portal in people with Pre-diabetes, run by UnitedHealth Group.
Trial summary
Over the past 40 years, diabetes has increased dramatically in parallel with rapid increases in obesity.About 90 to 95% of persons with diabetes have type 2 diabetes, which begins when the body becomes resistant to the hormone insulin. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pre-diabetes
- What is being tested?
- Virtual Diabetes Prevention Program and Interactive tracking and problem solving web portal
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 306 participants
- Where
- No sites listed yet
- Study dates
- Feb 2012to Sep 2014
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Told by a doctor, nurse, or other healthcare provider that he/she has prediabetes or is at very high risk for developing type 2 diabetes
- Told by a doctor, nurse or other healthcare provider that he/she has high blood pressure or is receiving prescription medication to treat high blood pressure
- Told by a doctor, nurse or other healthcare provider that he/she has abnormal blood cholesterol or is receiving prescription medication to treat blood cholesterol
- Has a first-degree blood relative (mother, father, brother or sister) who has or had type 2 diabetes
- Is a woman with a personal history of gestational diabetes (diabetes of pregnancy only)
Who cannot join
- Currently reports a body weight of more than 310 pounds
- Considering bariatric surgery ("stomach stapling" or gastric bypass) in the next 6 months
- Told by a doctor or nurse that they have diabetes (except diabetes of pregnancy alone) or is receiving any form of treatment for diabetes
- Has poorly controlled high blood pressure, typically more than 180/105, that has not been discussed with a healthcare provider
- Is a woman who is currently pregnant or actively planning pregnancy in the next 6 months
- Has chest pain, dizziness, or severe shortness of breath or bodily weakness with even moderate levels of physical exertion such as brisk walking
Show all 9Show fewer
- Has been told by a doctor or nurse not to increase his/her current level of physical activity or not to attempt weight loss
- Has any other condition, such as advanced heart or lung disease, severe painful arthritis, or another disability that significantly limits physical activities such as brisk walking
- Has any other condition, such as malnutrition or unexplained weight loss in which attempts to lose additional body weight could be unsafe
About this study
Over the past 40 years, diabetes has increased dramatically in parallel with rapid increases in obesity.About 90 to 95% of persons with diabetes have type 2 diabetes, which begins when the body becomes resistant to the hormone insulin. Insulin resistance results from weight gain and physical inactivity, making the vast majority of new cases of type 2 diabetes preventable with lifestyle changes.
After the findings of the Diabetes Prevention Program were released in 2002, the high cost of the lifestyle program prevented it from becoming widely adopted throughout the U.S.
Read more
The UnitedHealth Center for Health Reform and Modernization (CHRM) will evaluate the use and effectiveness of a scalable approach for providing lifestyle-based diabetes prevention intervention through Comcast's XFINITY Video-On-Demand (VOD) programming, with additional non-compulsory support from SparkPeopleTM (Cincinnati, Ohio), an interactive tracking and problem solving web portal. By design, this effort will engage adult television viewers and offer them education and resources to support their efforts to achieve levels of weight loss and physical activity which have previously shown to prevent the development of type 2 diabetes. Specifically, we aim to evaluate:
- Viewing patterns and characteristics of consumers accessing a prevention program via VOD
- Effectiveness in terms of weight loss achieved
- Consumers' ratings of overall content
Read the detailed description
Obesity, pre-diabetes, and diabetes are related diseases that are reaching epidemic proportions in the United States. In order to ultimately control health care costs, employers, private payers and public payers must address this issue with models that effectively identify individuals with these conditions and aggressively intervene to improve compliance with evidence-based care standards.
Project NOT ME leverages a proven model that drives earlier identification, improved individual compliance, better health outcomes, and lower costs for the consumer, the payer and plan sponsors. More specifically, Project NOT ME provides a solution by offering pre-diabetic participants access to a virtual program that includes a reality TV show, an electronic scale and trackers. Project NOT ME is an evidence-based intervention that follows the National Diabetes Prevention Program (DPP). It is designed to enact lifestyle changes that result in a safe reduction in weight, and a reduction in conversion to full blown type-2 diabetes.
Project NOT ME is divided in two parts --
- Program: For the first 20 weeks, participants work to become more aware of the food they eat, and the amount of exercise they are getting. The Video on Demand episodes educate participants on strategies that are proven to help them make better food choices, and find time in their lives to be more active. During the core program, participants will:
- Weigh themselves every week using a program-provided electronic scale that automatically records their weight and sends to the study team
- Log all the food they eat and all the exercise they are getting in a tracker
- Watch 16 episodes of a captivating reality based TV show that highlights 6 adults participating in the Diabetes Prevention Program.
- Review weekly online episode summaries.
- Maintenance Sessions: For the next 32 weeks, participants will practice what they learned in the Core Sessions, continue to track food and exercise, and have access to the television episodes.
- Conditions
- Pre-diabetes
- Being tested
- Virtual Diabetes Prevention Program, Interactive tracking and problem solving web portal
- Keywords
- Diabetes Prevention Program, obesity, activity, diabetes
- Medical subject headings
- Glucose Intolerance, Obesity, Motor Activity, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Diabetes Prevention ProgramBehavioural
Also called Lifestyle Change Program
Participants will view 16 Video On Demand reality based TV episodes that follow 6 adults with pre-diabetes actively participating in a DPP lifestyle intervention.
Interactive tracking and problem solving web portalBehavioural
Also called Web-based lifestyle support
| Study group | Role | What they receive |
|---|---|---|
| Video on Demand (VOD) | Experimental | Virtual Diabetes Prevention Program: All participants will view the 16 Comcast on Demand episodes, weigh themselves, and track their progress weekly. Participants in the VOD arm of the study received access to a paper tracker to track food and activity during the program. Receives: Behavioral: Virtual Diabetes Prevention Program |
| Video on Demand Plus (VOD+) | Experimental | Virtual Diabetes Prevention Program: All participants will view the 16 Comcast on Demand episodes, weigh themselves, and track their progress weekly. Participants in the VOD+ arm of the trial received access an interactive tracking and problem solving web portal offered by SparkPeople™ (Cincinnati, Ohio). Receives: Behavioral: Virtual Diabetes Prevention Program; Behavioral: Interactive tracking and problem solving web portal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Weight Measure at Week 16
Weight measures will be taken on electronic scales that transmit the weight using GSM/cellular technology at the start of the study, after each weekly episode, at the end of the evaluation period (week 16) and after all maintenance materials have been delivered (month 12). Self-reported weight will also be collected in the pre-study survey, follow-up survey and through SparkPeople.com.
Measured: Baseline - Week 16
Secondary outcomes (3)
Viewing patterns and characteristics of consumers accessing a prevention program via VOD
The following viewing data will be captured by Comcast and made available to the evaluation team with permission from the study participant: date and title for each episode viewed (date / time stamp for episode initiation, total viewing time, confirmation whether episode was viewed in its entirety or viewed more than once).
Measured: Week 16
Consumers' ratings of overall content
A survey will be be administered at week 16 containing health related and work productivty questions, the perceived usefulness of the content,intent to make changes in behavior and likelihood to recommend the program to others.
Measured: Week 16
Change from Baseline Weight Measure at Month 12
Weight measures will be taken on electronic scales that transmit the weight using GSM/cellular technology at the start of the study, after each weekly episode, at the end of the evaluation period (week 16) and after all maintenance materials have been delivered (month 12). Self-reported weight will also be collected in the pre-study survey, follow-up survey and through SparkPeople.com.
Measured: Baseline and Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2013 (estimated)
- Study startFeb 2012
- Primary completionMay 2013
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-diabetesStudies of the same condition, open and under way.
- 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
- 306 participants (actual)
Sponsor and investigators
- Lead sponsor
- UnitedHealth Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Comcast Corporation, Dr. Ron Ackermann
- Responsible party
- Principal investigator, Dr. Deneen Vojta, UnitedHealth Group
- Investigators
- Deneen Vojta, MD, Principal investigator, UnitedHealth Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01768546
- Sponsor's protocol ID
- Project NOT ME 11-351
- Acronym
- Project NOT ME
- Status last verified
- Dec 2014
- First submitted
- 9 Jan 2013
- Last updated
- 19 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Video On-Demand Programming to Prevent Type 2 Diabetes in Adults
- ClinicalTrials.gov ID
- NCT01768546
- Acronym / sponsor ID
- Project NOT ME / Project NOT ME 11-351
- Conditions
- Pre-diabetes
- Keywords
- Diabetes Prevention Program, obesity, activity, diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 306 participants (actual)
- Lead sponsor
- UnitedHealth GroupIndustry (pharma, biotech, devices)
- Collaborators
- Comcast Corporation, Dr. Ron Ackermann
- Study start
- Feb 2012
- Primary completion
- May 2013 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 15 Jan 2013 (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.
Over the past 40 years, diabetes has increased dramatically in parallel with rapid increases in obesity.About 90 to 95% of persons with diabetes have type 2 diabetes, which begins when the body becomes resistant to the hormone insulin. Insulin resistance results from weight gain and physical inactivity, making the vast majority of new cases of type 2 diabetes preventable with lifestyle changes.
After the findings of the Diabetes Prevention Program were released in 2002, the high cost of the lifestyle program prevented it from becoming widely adopted throughout the U.S.
The UnitedHealth Center for Health Reform and Modernization (CHRM) will evaluate the use and effectiveness of a scalable approach for providing lifestyle-based diabetes prevention intervention through Comcast's XFINITY Video-On-Demand (VOD) programming, with additional non-compulsory support from SparkPeopleTM (Cincinnati, Ohio), an interactive tracking and problem solving web portal. By design, this effort will engage adult television viewers and offer them education and resources to support their efforts to achieve levels of weight loss and physical activity which have previously shown to prevent the development of type 2 diabetes. Specifically, we aim to evaluate:
- Viewing patterns and characteristics of consumers accessing a prevention program via VOD
- Effectiveness in terms of weight loss achieved
- Consumers' ratings of overall content
Detailed description
Obesity, pre-diabetes, and diabetes are related diseases that are reaching epidemic proportions in the United States. In order to ultimately control health care costs, employers, private payers and public payers must address this issue with models that effectively identify individuals with these conditions and aggressively intervene to improve compliance with evidence-based care standards.
Project NOT ME leverages a proven model that drives earlier identification, improved individual compliance, better health outcomes, and lower costs for the consumer, the payer and plan sponsors. More specifically, Project NOT ME provides a solution by offering pre-diabetic participants access to a virtual program that includes a reality TV show, an electronic scale and trackers. Project NOT ME is an evidence-based intervention that follows the National Diabetes Prevention Program (DPP). It is designed to enact lifestyle changes that result in a safe reduction in weight, and a reduction in conversion to full blown type-2 diabetes.
Project NOT ME is divided in two parts --
- Program: For the first 20 weeks, participants work to become more aware of the food they eat, and the amount of exercise they are getting. The Video on Demand episodes educate participants on strategies that are proven to help them make better food choices, and find time in their lives to be more active. During the core program, participants will:
- Weigh themselves every week using a program-provided electronic scale that automatically records their weight and sends to the study team
- Log all the food they eat and all the exercise they are getting in a tracker
- Watch 16 episodes of a captivating reality based TV show that highlights 6 adults participating in the Diabetes Prevention Program.
- Review weekly online episode summaries.
- Maintenance Sessions: For the next 32 weeks, participants will practice what they learned in the Core Sessions, continue to track food and exercise, and have access to the television episodes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Video on Demand (VOD) | Experimental | Behavioral: Virtual Diabetes Prevention ProgramVirtual Diabetes Prevention Program: All participants will view the 16 Comcast on Demand episodes, weigh themselves, and track their progress weekly. Participants in the VOD arm of the study received access to a paper tracker to track food and activity during the program. |
| Video on Demand Plus (VOD+) | Experimental | Behavioral: Virtual Diabetes Prevention Program, Behavioral: Interactive tracking and problem solving web portalVirtual Diabetes Prevention Program: All participants will view the 16 Comcast on Demand episodes, weigh themselves, and track their progress weekly. Participants in the VOD+ arm of the trial received access an interactive tracking and problem solving web portal offered by SparkPeople™ (Cincinnati, Ohio). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Told by a doctor, nurse, or other healthcare provider that he/she has prediabetes or is at very high risk for developing type 2 diabetes
- Told by a doctor, nurse or other healthcare provider that he/she has high blood pressure or is receiving prescription medication to treat high blood pressure
- Told by a doctor, nurse or other healthcare provider that he/she has abnormal blood cholesterol or is receiving prescription medication to treat blood cholesterol
- Has a first-degree blood relative (mother, father, brother or sister) who has or had type 2 diabetes
- Is a woman with a personal history of gestational diabetes (diabetes of pregnancy only)
Key exclusion criteria (9 listed)
- Currently reports a body weight of more than 310 pounds
- Considering bariatric surgery ("stomach stapling" or gastric bypass) in the next 6 months
- Told by a doctor or nurse that they have diabetes (except diabetes of pregnancy alone) or is receiving any form of treatment for diabetes
- Has poorly controlled high blood pressure, typically more than 180/105, that has not been discussed with a healthcare provider
- Is a woman who is currently pregnant or actively planning pregnancy in the next 6 months
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 |
|---|---|---|
| Virtual Diabetes Prevention ProgramAlso: Lifestyle Change ProgramParticipants will view 16 Video On Demand reality based TV episodes that follow 6 adults with pre-diabetes actively participating in a DPP lifestyle intervention. | Behavioural | Video on Demand (VOD), Video on Demand Plus (VOD+) |
| Interactive tracking and problem solving web portalAlso: Web-based lifestyle support | Behavioural | Video on Demand Plus (VOD+) |
Primary outcome
Change from Baseline Weight Measure at Week 16
Time frame: Baseline - Week 16
Weight measures will be taken on electronic scales that transmit the weight using GSM/cellular technology at the start of the study, after each weekly episode, at the end of the evaluation period (week 16) and after all maintenance materials have been delivered (month 12). Self-reported weight will also be collected in the pre-study survey, follow-up survey and through SparkPeople.com.
3 secondary outcomes
Viewing patterns and characteristics of consumers accessing a prevention program via VOD
Time frame: Week 16
Consumers' ratings of overall content
Time frame: Week 16
Change from Baseline Weight Measure at Month 12
Time frame: Baseline and Month 12
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 19 Dec 2014.
Related trials for Pre-diabetes
Not yet recruiting
Different Aerobic-to-Resistance Training Ratios in Adults Aged 50 Years and Older With Prediabetes
Prediabetes
Not yet recruitingEarly Phase 1
Efficacy of the pA1c®HI Postbiotic in Metabolic Regulation in Healthy Individuals With Hyperglycemia
Hyperglycemias, Prediabetes
Recruiting
Smartwatch-based Intervention for Cardiovascular Health (SWITCH)
Overweight , Obesity, Prediabetes
Recruiting
Neuromodulation for Metabolic Dysfunction
Spinal Cord Injuries (SCI), Prediabetes / Type 2 Diabetes
Not yet recruiting
Effects of Mango on Insulin Sensitivity in Prediabetes
Pre Diabetes
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.
Deneen Vojta, MD principal investigator
UnitedHealth Group
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Diabetes Prevention Program and Interactive tracking and problem solving web portal in people with Pre-diabetes, run by UnitedHealth Group.
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 5 inclusion and 9 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 19 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
Change from Baseline Weight Measure at Week 16 (time frame: Baseline - Week 16). 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 19 Dec 2014.