A research study for adults at risk of developing type 2 diabetes

You have agreed to be part of a research study for diabetes prevention. The information below describes what that means for you and provides information about the benefits and risks related to the study.

Why is this study being done?

There are millions of adults struggling with the health problems caused by extra weight, specifically type 2 diabetes. Once an individual has diabetes, they are at risk for other serious health issues. The study will determine if viewing a TV series can help reduce the chance of developing diabetes by teaching lifestyle change.

What does it mean to be part of a research study?

A research study is a way to find answers to scientific or health questions. The purpose of this study is to find out if viewing a TV series along with weekly weigh-ins and tracking tools can help participants achieve a healthier body weight and reduce the chance of developing diabetes.

Who is eligible for the study?

Participants must be 18 years or older, struggle with extra weight, and have at least one risk factor for developing type 2 diabetes. Participation in Project NOT ME must not put an individual’s health at risk. Also, in order to watch the Project NOT ME episodes, participants must be Comcast subscribers with On Demand service in one of the designated study areas - the greater metro areas of Philadelphia, PA or Knoxville, TN.

Can I really reduce my chance of developing type 2 diabetes?

The National Diabetes Prevention Program (DPP) showed over HALF of new cases of type 2 diabetes could be prevented with a lifestyle program. Diabetes prevention has been shown to work regardless of gender, age, race, or ethnicity.

How will the study work?

Study Location: You will view all Project NOT ME episodes in the comfort of your own home

Study Length: 12-months, including weekly activities for the first 5 months

Study Tools: You will receive four tools that support lifestyle change:

  1. 16 weekly 20 to 30-minute episodes delivered through Comcast On Demand
  2. A state-of-the-art electronic scale to help track your progress
  3. Tracking tools to monitor your activity patterns and eating habits
  4. Tips for staying healthy after the episodes end
We'll also call you once a week to check on your progress, get your feedback, and preview what you can expect in the next episode. The Study Team will also call participants each week to check progress, get feedback, and preview the next episode.

Participant Feedback: You will be asked to complete a survey before the study starts and after you have viewed all 16 On Demand episodes

Can anyone in my household use the study tools?

Anyone in your household may view the Project NOT ME episodes. However, we ask that only you (the study participant) use the electronic scale and tracking tools. The electronic scale cannot tell the difference between you and other people who might step onto it. Please do not let anyone else in your household use the scale until the study is finished.

Who teaches the classes in the Project NOT ME episodes and what are their qualifications?

The TV and online coaches are trained Diabetes Prevention Program facilitators with behavioral coaching experience. If you have a medical question during the study, you should contact your doctor or healthcare professional.

What can I expect from the Project NOT ME episodes?

In each episode, you will watch a health and wellness facilitator lead a class of real students (just like you) who are all working to reach a healthier weight and lower their risk of diabetes. The lessons the facilitators deliver are based on a national study in which participants significantly lowered their risk of developing type 2 diabetes through lifestyle change.
Through the narrator the Project NOT ME episodes share educational, behavioral, and problem-solving strategies to help manage weight and encourage healthy behaviors.

If I forget to watch an episode one week, will I be able to watch it later?

Yes -- all episodes will be uploaded to Comcast On Demand and available for viewing for the 12-month study period. You may watch each episode as many times as you would like.

What is my time commitment at home between episodes?

Between each episode, you will practice the skills you learn from the episodes at home throughout the week. You will have “tracking” assignments and opportunities to put what you learn into action. Assignments may include tracking your food intake, activity, sleep, etc. Plan on spending about an hour and a half per week (about 15 minutes each day) working on your Project NOT ME goals.

Will we exercise during the Project NOT ME episodes? Is physical activity involved?

The Project NOT ME Study is not an exercise program. Project NOT ME provides you with tools and realistic strategies to achieve a healthier weight and lifestyle, such as reducing less healthy foods and drinks and encouraging physical activity. Excess weight occurs when energy intake (the food we eat) and energy we use (our activity) are out of balance. For effective weight management, the best place to focus first is on the food side of the balance. But you are also encouraged to find time each day for physical activity. As the program progresses, more time is dedicated to strategies to incorporate physical activity into your lifestyle.

Does my doctor or healthcare provider need to approve my enrollment in this study?

Because there are minimal risks to participating in this study, you do not need the approval of your doctor or healthcare provider to enroll. However, you may want to speak to a physician if you have concerns about participation. If you have general questions about the study, please call the Study Team at 1-877-304-1725 for more information.

Will it cost me anything to be in the study?

This study is available to participants at no cost due to the support of UnitedHealth Group and Comcast.

Do I need to be a Comcast subscriber to participate in the study?

Yes, you must be a Comcast subscriber with On Demand service in the designated study area.

Do I need to have UnitedHealthcare insurance to participate in the study?

No, this study is for the general public.

Will my information be kept private?

We will only collect personal information that is needed to communicate with you and to monitor your progress. Records of your participation in this study will be kept confidential and will not be shared with anyone outside of the Study Team. Documents with study data will be labeled using a study code, not your name. Security codes will be used to protect all computerized records. Only primary investigators, study representatives, the sponsor and the New England Institutional Review Board will have access to study data.
Comcast is not collecting or storing any personal medical information, although Comcast will provide information regarding the frequency and duration of each participant's views of the episodes.
Under certain circumstances, the study doctor, the sponsor or its designee, the Food and Drug Administration (FDA), and the New England Institutional Review Board will be able to access and review confidential data that identifies you by name. Any publication or presentation of the data will be combined and will not be presented at the individual level.

Are there risks to being in the study?

There are minimal risks associated with participating in this study. Risks are limited to any discomfort you may feel completing survey questions about your health and quality of life. You may refuse to answer any question that makes you feel uncomfortable, excluding those related to Body Mass Index (BMI). If you have questions or concerns about the surveys, you can contact the Study Team at 1-877-304-1725 Monday through Friday from 9:00am to 9:00pm EST.
The loss of confidentiality is also a potential risk of being in the study. We will take precautions to keep your personal information private and de-identified.

Will I be informed of new information relating to the study?

All new findings discovered during the course of this research study that may reasonably influence your decision to continue to participate in this study will be provided to you by the Primary Investigator, as such information becomes available.

Who should I contact in the event of an emergency?

If you have an emergency during the course of the study, you should immediately contact your physician to discuss treatment options. If risks are life-threatening, immediately call 911.

Once I enroll, do I have to participate in the study?

Your participation in the study is completely voluntary. You may leave the study at any time, without penalty. To withdraw from the Project NOT ME Study, please contact the Study Team at 1-877-304-1725 Monday through Friday from 9:00am to 9:00pm EST. If you withdraw, any data already collected will be kept in our records. Additionally, you will not receive gift cards for your participation.

What if I have questions about the study?

If you have questions or concerns about the study, please call 1-877-304-1725 Monday through Friday from 9:00am to 9:00pm EST.
If you have questions about your rights as a research subject, or other concerns about the research, you can contact the New England Institutional Review Board (NEIRB) at 1-800-232-9570.

Can I still be in the study if I do not wish to receive email messages or weekly phone calls?

As a study participant, you may choose not to receive automated email reminders or automated phone calls with tips and healthy reminders. However, the Study Team may reach out to you personally over email or phone about study questions or concerns.

What should I do if I have technical issues?

If you have trouble viewing the episodes, using your scale, or using your tracking tools, please contact the Study Team at 1-877-304-1725.