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PH iWell Study to Compare an Online Interactive Technology to Self-directed Care in Overweight or Obese Individuals

17. april 2011 opdateret af: SK Telecom Americas, Inc.

SKTA iWell21 Clinical Trial Protocol. This is a Randomized Control Trial of 500 Adult Participants Randomized to Two Arms: Control Arm: Self Directed Program (SDP), Intervention Arm: Dynamic On-line Interactive Technology (DOIT)

This is a six month lifestyle management study to compare the effects of iWell; a dynamic online interactive technology to a self-directed program in overweight or obese individuals.

The primary aim is to test the hypothesis that dynamic online interactive technology intervention is more effective than self-directed program in obtaining and maintaining weight loss and other biometric improvements.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Optimal health behavior is difficult to sustain over extended periods. This study seeks to demonstrate that technology can be a low cost scaleable solution that will provide the user with sufficient customization and personalization through social networking approaches such that sustainability of optimal health behavior is realized.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

500

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Oregon
      • Springfield, Oregon, Forenede Stater, 97477
        • PeaceHealth Laboratories

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • age 18-70 years old
  • overweight or obese men and women with BMI between 24 and 38, inclusive
  • concerned about weight/health (and motivated in losing weight)
  • stable medications for past 3 months
  • willing/able to use Web-based services
  • willingness not to use weight loss medications for the duration of the trial
  • able and willing to give informed consent and participate in the interventions
  • willing to come to three sessions and visits
  • willingness to be randomized to intervention or control group

Exclusion Criteria:

  • contraindication to weight loss (e.g., malignancy or other serious illness)
  • Type 1 DM and Type 2 DM with other end organ compromise (renal, retinal or other)
  • Recent (within 6 months) cardiovascular event (MI or stroke)
  • current symptoms of angina
  • heart, renal, or liver disease (excluding kidney stone)
  • cancer or active neoplasm (excluding skin cancers)
  • hyperthyroidism
  • mental conditions that would preclude full participation
  • prior weight-loss (bariatric) surgery or plan for these procedures
  • liposuction surgery in past 12 months or plan for these procedures
  • recent weight loss in the past 3 months (>20 lbs)
  • use of prescription weight loss medication in 3 months prior to screening
  • current use of medications for treatment of psychosis or manic-depressive illness

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: Self directed
Adfærdsmæssigt: Self directed
Receives support and encouragement with minimal contact. Receives printed lifestyle guidelines with diet and physical activity recommendations.
Andre navne:
  • Standard pleje
Aktiv komparator: Technology assisted health behavior
The intervention arm will have access to a dynamic online environment with social networking and device data uploads that include activity data, weight data and laboratory data at frequent intervals to nudge optimal health behavior.
Adfærdsmæssigt: Technology assisted health behavior
Web-based interactive program using an hpod sensor that tracks physical activity as well as biometric parameters into the iWell server and is transmitted to the internet site via the users PC. Also serves as a social networking site.
Andre navne:
  • DOIT Dynamic online interactive technology

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Weight loss from baseline
Tidsramme: at 6 months
at 6 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Blood pressure change from baseline
Tidsramme: at 3 months
Systolic blood pressure and diastolic blood pressure
at 3 months
Triglyceride level change from baseline
Tidsramme: at 3 months
Participants will have a venous draw to determine Triglyceride levels
at 3 months
High density lipoprotein level change from baseline
Tidsramme: at 3 months
Venous draw to determine high density lipoprotein levels
at 3 months
Physical activity adjustment from baseline
Tidsramme: at 3 months
Standardized activity questionaire and activity monitoring device will be used to determine adjustments in activity for each arm
at 3 months
Blood pressure change from baseline
Tidsramme: at 6 months
at 6 months
Triglyceride level change from baseline
Tidsramme: at 6 months
at 6 months
High density lipoprotein level change from baseline
Tidsramme: at 6 months
at 6 months
Physical activity adjustment from baseline
Tidsramme: at 6months
Standardized activity questionaire and activity monitoring device will be used to determine adjustments in activity for each arm
at 6months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

SK Telecom Americas, Inc.

Samarbejdspartnere

PeaceHealth Laboratories

Efterforskere

  • Ledende efterforsker: Brigitte Piniewski, MD, PeaceHealth Laboratories
  • Ledende efterforsker: David Kil, SKTelecom Americas

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. oktober 2010

Primær færdiggørelse (Forventet)

1. oktober 2011

Studieafslutning (Forventet)

1. oktober 2012

Datoer for studieregistrering

Først indsendt

22. oktober 2010

Først indsendt, der opfyldte QC-kriterier

28. marts 2011

Først opslået (Skøn)

29. marts 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

19. april 2011

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

17. april 2011

Sidst verificeret

1. april 2011

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • SKTA iWell 21

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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Sponsor / samarbejdspartnere

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