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Evaluation of Video On-Demand Programming to Prevent Type 2 Diabetes in Adults (Project NOT ME)

Primary Purpose

Pre-diabetes

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Virtual Diabetes Prevention Program
Interactive tracking and problem solving web portal
Sponsored by
UnitedHealth Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pre-diabetes focused on measuring Diabetes Prevention Program, obesity, activity, diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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
  • 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Video on Demand (VOD)

    Video on Demand Plus (VOD+)

    Arm Description

    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.

    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).

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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).
    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.
    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.

    Full Information

    First Posted
    January 9, 2013
    Last Updated
    December 17, 2014
    Sponsor
    UnitedHealth Group
    Collaborators
    Comcast Corporation, Dr. Ron Ackermann
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01768546
    Brief Title
    Evaluation of Video On-Demand Programming to Prevent Type 2 Diabetes in Adults
    Acronym
    Project NOT ME
    Official Title
    Evaluation of Video On-Demand Programming to Prevent Type 2 Diabetes in Adults
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2012 (undefined)
    Primary Completion Date
    May 2013 (Actual)
    Study Completion Date
    September 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    UnitedHealth Group
    Collaborators
    Comcast Corporation, Dr. Ron Ackermann

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief 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. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pre-diabetes
    Keywords
    Diabetes Prevention Program, obesity, activity, diabetes

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    306 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Video on Demand (VOD)
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Video on Demand Plus (VOD+)
    Arm Type
    Experimental
    Arm Description
    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).
    Intervention Type
    Behavioral
    Intervention Name(s)
    Virtual Diabetes Prevention Program
    Other Intervention Name(s)
    Lifestyle Change Program
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Interactive tracking and problem solving web portal
    Other Intervention Name(s)
    Web-based lifestyle support
    Primary Outcome Measure Information:
    Title
    Change from Baseline Weight Measure at Week 16
    Description
    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.
    Time Frame
    Baseline - Week 16
    Secondary Outcome Measure Information:
    Title
    Viewing patterns and characteristics of consumers accessing a prevention program via VOD
    Description
    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).
    Time Frame
    Week 16
    Title
    Consumers' ratings of overall content
    Description
    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.
    Time Frame
    Week 16
    Title
    Change from Baseline Weight Measure at Month 12
    Description
    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.
    Time Frame
    Baseline and Month 12

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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) Exclusion Criteria: 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 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Deneen Vojta, MD
    Organizational Affiliation
    UnitedHealth Group
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Evaluation of Video On-Demand Programming to Prevent Type 2 Diabetes in Adults

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