Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01768546
Other study ID # Project NOT ME 11-351
Secondary ID
Status Completed
Phase N/A
First received January 9, 2013
Last updated December 17, 2014
Start date February 2012
Est. completion date September 2014

Study information

Verified date December 2014
Source UnitedHealth Group
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 306
Est. completion date September 2014
Est. primary completion date May 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

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


Related Conditions & MeSH terms


Intervention

Behavioral:
Virtual Diabetes Prevention 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 portal


Locations

Country Name City State
n/a

Sponsors (3)

Lead Sponsor Collaborator
UnitedHealth Group Comcast Corporation, Dr. Ron Ackermann

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Baseline - Week 16 No
Secondary 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). Week 16 No
Secondary 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. Week 16 No
Secondary 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. Baseline and Month 12 No
See also
  Status Clinical Trial Phase
Completed NCT04082585 - Total Health Improvement Program Research Project
Enrolling by invitation NCT05367024 - Broccoli Effect on Glycated Haemoglobin (HbA1c) N/A
Completed NCT02933424 - Project Plant Protein: the P3 Study in Humans N/A
Withdrawn NCT02400450 - Designer Functional Foods on Parameters of Metabolic and Vascular in Prediabetes N/A
Completed NCT02656212 - Early Phase Pre-Clinical and Initial Clinical Research on Epicatechin (Part 2) Phase 1
Completed NCT02330276 - Early Phase Pre-Clinical and Initial Clinical Research on Epicatechin Phase 1
Completed NCT01488279 - Effect of Sitagliptin on Short-Term Metabolic Dysregulation of Oral Glucocorticoid Therapy N/A
Completed NCT00831129 - A Study for Pre-diabetic Patients With Cholesterol Lowering Drugs Phase 2/Phase 3
Completed NCT00536250 - Study to Investigate the Pathophysiology of Type 2 Diabetes in Youth N/A
Recruiting NCT05563090 - Investigating the Syndrome Differentiation of Diabetic and Pre-diabetic Using Digitalized TCM Diagnostic Tools
Active, not recruiting NCT04991142 - Models of Nutrition From Continuous Glucose Monitors
Completed NCT02759055 - Pre-Diabetes Cardiovascular (CV) Care (Pre-Diabetes Wizard) N/A
Completed NCT00775684 - Effect of Exenatide, Sitagliptin or Glimepiride on Functional ß -Cell Mass N/A
Completed NCT03695913 - Continuous Glucose Monitoring (CGM) With a Low Carbohydrate Diet to Reduce Weight in Patients With Pre-Diabetes N/A
Completed NCT04051008 - CTSI Pilot: Improving Adherence to Diabetic Diet N/A
Recruiting NCT04897945 - A Shared Decision Making Intervention for Diabetes Prevention in Women With a History of Gestational Diabetes Mellitus N/A
Not yet recruiting NCT04442451 - Mechanisms of Fatigability With Diabetes N/A
Not yet recruiting NCT05925933 - High Protein Diet on Transcriptomic, Metabolomics, Hepatic and Pancreatic Fat Anatomy and Physiology in Asian Indians With Pre-diabetes N/A
Active, not recruiting NCT05654051 - The SLIM LIVER Study Phase 2
Completed NCT02919397 - Motivational Instant Messaging and E-diabetes Prevention Programme for High Risk of Type 2 Diabetes N/A