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

17 grudnia 2014 zaktualizowane przez: Dr. Deneen Vojta, UnitedHealth Group

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

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

306

Faza

  • Nie dotyczy

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Zapobieganie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Video on Demand (VOD)
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.
Behawioralne: 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.
Inne nazwy:
  • Lifestyle Change Program
Eksperymentalny: Video on Demand Plus (VOD+)
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).
Behawioralne: 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.
Inne nazwy:
  • Lifestyle Change Program
Behawioralne: Interactive tracking and problem solving web portal
Inne nazwy:
  • Web-based lifestyle support

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change from Baseline Weight Measure at Week 16
Ramy czasowe: Baseline - 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Viewing patterns and characteristics of consumers accessing a prevention program via VOD
Ramy czasowe: Week 16
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
Consumers' ratings of overall content
Ramy czasowe: Week 16
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
Change from Baseline Weight Measure at Month 12
Ramy czasowe: Baseline and 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

UnitedHealth Group

Współpracownicy

Comcast Corporation
Dr. Ron Ackermann

Śledczy

  • Główny śledczy: Deneen Vojta, MD, UnitedHealth Group

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów

1 lutego 2012

Zakończenie podstawowe (Rzeczywisty)

1 maja 2013

Ukończenie studiów (Rzeczywisty)

1 września 2014

Daty rejestracji na studia

Pierwszy przesłany

9 stycznia 2013

Pierwszy przesłany, który spełnia kryteria kontroli jakości

11 stycznia 2013

Pierwszy wysłany (Oszacować)

15 stycznia 2013

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Oszacować)

19 grudnia 2014

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

17 grudnia 2014

Ostatnia weryfikacja

1 grudnia 2014

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • Project NOT ME 11-351

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Badania kliniczne na Stan przedcukrzycowy

Badania kliniczne na Virtual Diabetes Prevention Program

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