NCT01768546

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:

  1. 1.Viewing patterns and characteristics of consumers accessing a prevention program via VOD
  2. 2.Effectiveness in terms of weight loss achieved
  3. 3.Consumers' ratings of overall content

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
306

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2012

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 9, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 15, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

December 19, 2014

Status Verified

December 1, 2014

Enrollment Period

1.2 years

First QC Date

January 9, 2013

Last Update Submit

December 17, 2014

Conditions

Pre-diabetes

Keywords

Diabetes Prevention Programobesityactivitydiabetes

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

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

    Week 16

  • Consumers' ratings of overall content

    Week 16

  • Change from Baseline Weight Measure at Month 12

    Baseline and Month 12

Study Arms (2)

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.

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).

Behavioral: Virtual Diabetes Prevention ProgramBehavioral: Interactive tracking and problem solving web portal

Interventions

Virtual Diabetes Prevention ProgramBEHAVIORAL

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.

Also known as: Lifestyle Change Program
Video on Demand (VOD)Video on Demand Plus (VOD+)
Interactive tracking and problem solving web portalBEHAVIORAL
Also known as: Web-based lifestyle support
Video on Demand Plus (VOD+)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Glucose IntoleranceObesityMotor ActivityDiabetes Mellitus

Condition Hierarchy (Ancestors)

HyperglycemiaGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehaviorEndocrine System Diseases

Study Officials

  • Deneen Vojta, MD

    UnitedHealth Group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Deneen Vojta Vice President of Center for Health Reform and Modernization

Study Record Dates

First Submitted

January 9, 2013

First Posted

January 15, 2013

Study Start

February 1, 2012

Primary Completion

May 1, 2013

Study Completion

September 1, 2014

Last Updated

December 19, 2014

Record last verified: 2014-12