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Clinical 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. 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:

1. Viewing patterns and characteristics of consumers accessing a prevention program via VOD

2. Effectiveness in terms of weight loss achieved

3. Consumers' ratings of overall content


Clinical Trial 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 --

1. 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.

2. 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


NCT number NCT01768546
Study type Interventional
Source UnitedHealth Group
Contact
Status Completed
Phase N/A
Start date February 2012
Completion date September 2014

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