- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00265954
Internet Assisted Obesity Treatment (iReach)
2. august 2019 opdateret af: Jean R. Harvey, PhD, RD, University of Vermont
A Randomized Trial of an Internet Versus In-person Behavioral Weight Loss Treatment Program.
High quality behavioral weight loss programs are not widely accessible.
The Internet offers one way to deliver health behavior programs to a wider audience.
However, effective weight loss treatments are intensive and program delivery over the Internet may not be capable of duplicating the level of engagement typically generated during traditional in-person treatment.
The goal of this study is to test the effectiveness of three weight loss interventions: Internet alone, Internet+periodic in-person support, and in-person alone.
The investigators hypothesize that the in-person and internet+in-person interventions will produce better weight loss and maintenance than the internet only group.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Currently 65% of the adult population is overweight or obese.
Unfortunately, safe and effective treatments for obesity are costly and intensive; therefore, this level of support is unlikely to be feasible in most clinical settings.
Moreover, an additional limitation to current obesity treatment approaches is the limited reach and availability of programs for persons who work, live in rural areas or do not want, or cannot afford participation in group support classes.
The advent of telecommunications technology may provide a solution to this dilemma.
Telecommunications technology can presumably improve access to services and improve efficiency of delivery.
Moreover, research examining new technologies such as the Internet, will provide information for policy makers interested in disseminating low-cost, high reach effective obesity treatment interventions.
However, the effectiveness of the Internet for inducing weight loss has not been rigorously tested.
Therefore, the overall goal of this project is to determine if obesity treatment can be effectively delivered over the Internet.
A secondary aim is to evaluate whether the effectiveness of Internet interventions can be improved with the addition of minimal in-person support.
Specifically, this project is a randomized, controlled clinical trial designed to test the translation of a behavioral weight loss program to the Internet (I).
The I intervention will be compared to both an in-person condition (IP) and an Internet condition supplemented with periodic in-person support (I+IP).
Subjects will be 488 (30% minority) overweight and obese adults recruited from Vermont and Arkansas who will participate in a 6-month behavioral weight control treatment program followed by 12 months of weight maintenance.
Assessments will include measures of body weight, adherence to treatment goals, social influence components and frequency of use of Internet website features.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
481
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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-
Arkansas
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Little Rock, Arkansas, Forenede Stater, 72205
- University of Arkansas for the Medical Sciences
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Vermont
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Burlington, Vermont, Forenede Stater, 05405
- University of Vermont
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-
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 og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- >18 years old
- BMI>25
- Internet access
Exclusion Criteria:
- pregnancy
- major medical problems
- inability to walk for exercise
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: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 1
Individuals in this arm receive a 6 month behavioral weight loss intervention delivered on-line.
Groups meet via a web chat weekly for 24 weeks and monthly for the following 12 months.
|
All participants receive an 18 month behavioral weight loss program that meets weekly for the first 6 months and monthly for the next year.
|
|
Eksperimentel: 2
In-person; Individuals in the in-person condition attend weekly group behavioral weight loss sessions for 24 weeks and then monthly sessions for the following 12 months.
|
All participants receive an 18 month behavioral weight loss program that meets weekly for the first 6 months and monthly for the next year.
|
|
Eksperimentel: 3
In-person+internet; Individuals in this condition receive a behavioral weight loss intervention over the internet weekly for 24 weeks and monthly for the following 12 months.
Every month during the first 24 weeks and every third month during the following year they have an in-person meeting.
|
All participants receive an 18 month behavioral weight loss program that meets weekly for the first 6 months and monthly for the next year.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Body Mass Index or body weight change
Tidsramme: 0, 6, 12, 18 month time points
|
0, 6, 12, 18 month time points
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Social support, diet, exercise, adherence to treatment components
Tidsramme: 0, 6, 12, 18 months
|
0, 6, 12, 18 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Jean Harvey-Berino, PhD, University of Vermont
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
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. februar 2006
Primær færdiggørelse (Faktiske)
1. oktober 2009
Studieafslutning (Faktiske)
1. oktober 2009
Datoer for studieregistrering
Først indsendt
14. december 2005
Først indsendt, der opfyldte QC-kriterier
14. december 2005
Først opslået (Skøn)
15. december 2005
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
6. august 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
2. august 2019
Sidst verificeret
1. august 2019
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- DK56746
- R01DK056746 (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 .