Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

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

17 dicembre 2014 aggiornato da: 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

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

306

Fase

  • Non applicabile

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Comportamentale: 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.
Altri nomi:
  • Lifestyle Change Program
Sperimentale: 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).
Comportamentale: 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.
Altri nomi:
  • Lifestyle Change Program
Comportamentale: Interactive tracking and problem solving web portal
Altri nomi:
  • Web-based lifestyle support

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change from Baseline Weight Measure at Week 16
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Viewing patterns and characteristics of consumers accessing a prevention program via VOD
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

UnitedHealth Group

Collaboratori

Comcast Corporation
Dr. Ron Ackermann

Investigatori

  • Investigatore principale: Deneen Vojta, MD, UnitedHealth Group

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 febbraio 2012

Completamento primario (Effettivo)

1 maggio 2013

Completamento dello studio (Effettivo)

1 settembre 2014

Date di iscrizione allo studio

Primo inviato

9 gennaio 2013

Primo inviato che soddisfa i criteri di controllo qualità

11 gennaio 2013

Primo Inserito (Stima)

15 gennaio 2013

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

19 dicembre 2014

Ultimo aggiornamento inviato che soddisfa i criteri QC

17 dicembre 2014

Ultimo verificato

1 dicembre 2014

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • Project NOT ME 11-351

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Pre-diabete

Prove cliniche su Virtual Diabetes Prevention Program

Cerca prove simili

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

CROs by country

CROs in Tanzania

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

3
Sottoscrivi