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Experience Success: Virtual Reality Skills Training to Enhance e-Weight Loss

18. juli 2016 opdateret af: The Miriam Hospital
The aim of this Phase II Small Business Technology Transfer grant is to complete development of a virtual reality intervention to augment and improve commercial Internet-delivered behavioral weight loss treatments, and to test it in a randomized controlled trial.

Studieoversigt

Detaljeret beskrivelse

Overweight and obesity are major health problems, affecting over two-thirds of US adults. Commercially available Internet-based weight loss programs are currently used by millions of overweight/obese individuals in the U.S, but weight losses are often poor, likely because these products on the whole do not incorporate empirically validated behavioral weight loss strategies that have been researched for over 40 years. Similarly, the weight losses obtained via research-based online weight loss programs are about half the size of those obtained via in-person treatment, likely because of the lack of (1) "hands-on" training in behavioral weight control strategies, and (2) support and guidance from group leaders and peers, both of which are hallmarks of traditional in-person treatment. The goal of this application is to improve commercial Internet -delivered behavioral obesity treatments by developing a virtual reality (VR) system that can be integrated into existing Internet weight control programs, such as Weight Watchers Online. The VR system will allow users to experience learning, implementing, and mastering behavioral weight control strategies in controlled virtual settings. The VR system will: (a) increase awareness of barriers to weight control behaviors, (b) teach skills to cope with these barriers, (c) build confidence using these skills, and (d) increase commitment to using these skills in real-world situations. The design of the VR System is based on Social Cognitive Theory, which states that health behaviors are learned by observing and imitating peers and role models, and by receiving social reinforcement. A randomized controlled trial (RCT) will be conducted with N = 125 participants to test the efficacy of 4 scenarios for improving weight losses obtained in a popular paid commercial weight loss program (Weight Watchers Online) over 6 months.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

125

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

    • Rhode Island
      • Providence, Rhode Island, Forenede Stater, 02903
        • Rekruttering
        • The Miriam Hospital Weight Control and Diabetes Research Center
        • Ledende efterforsker:
          • Graham Thomas, PHD
        • Kontakt:

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:

  • body mass index (BMI) 25-45 kg/m^2
  • English speaking and literate
  • able to walk 2 blocks unassisted without stopping
  • access to a computer and the Internet

Exclusion Criteria:

  • report of a heart condition, chest pain during periods of activity or rest, or loss of consciousness
  • a medical condition that would affect the safety and/or efficacy of a weight management program involving diet and physical activity
  • report of a condition that in the judgment of the Principal Investigator would render the participant potentially unlikely to be able to follow the study protocol for 6 months, including terminal illness, substance abuse, eating disorder, dementia, or other significant uncontrolled psychiatric problem
  • currently pregnant, within 6-months postpartum, or intend to become pregnant within 6 months
  • plan to move out of the local geographic area within 6 months
  • previous participation in a weight loss study at the Weight Control and Diabetes Research Center of Brown University and The Miriam Hospital within the last 2 years
  • current participation in another behavioral weight control program

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Weight Watchers Online
Participants will receive 6 months of no-cost access to the Weight Watchers Online platform.
Eksperimentel: Weight Watchers Online + Experience Success
Participants will receive 6 months of no-cost access to the Weight Watchers Online platform. They will also receive 6 months of no-cost access to the Experience Success online platform, with 4 virtual reality scenarios for training in behavioral weight loss skills.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Weight loss
Tidsramme: 3 months after beginning treatment
3 months after beginning treatment
Weight loss
Tidsramme: 6 months after beginning treatment
6 months after beginning treatment

Samarbejdspartnere og efterforskere

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

Samarbejdspartnere

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. juli 2016

Primær færdiggørelse (Forventet)

1. juli 2017

Studieafslutning (Forventet)

1. juli 2017

Datoer for studieregistrering

Først indsendt

14. juli 2016

Først indsendt, der opfyldte QC-kriterier

14. juli 2016

Først opslået (Skøn)

18. juli 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

19. juli 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. juli 2016

Sidst verificeret

1. juli 2016

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • R42DK103537 (U.S. NIH-bevilling/kontrakt)

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 .

Kliniske forsøg med Weight Watchers Online

3
Abonner