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Web Based Follow up Intervention in Obesity Treatment for Women

6. marts 2015 opdateret af: FEM Süd

Effects on Self-efficacy, Sustainability and Drop Out Rate Using Web Based Follow up Intervention in Obesity Treatment for Women

This study is designed to verify that web based follow up intervention after a classic multidisciplinary face-to-face obesity treatment will reinforced nutrition and exercise self-efficacy, improve drop out rate and advance sustainability after weight loss of obese women.

Research Questions and Hypotheses

  • How does a web based follow up intervention change self-efficacy of women participating in an obesity intervention?
  • How does a web based follow up intervention affect the drop out rate of women participating in an obesity intervention?
  • How does a web based follow up intervention influence sustainability of women participating in an obesity intervention?

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

84

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

      • Vienna, Østrig, 1100
        • FEM Süd

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 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

Inclusion Criteria:

  • Women
  • Age 18-80
  • BMI 30-40
  • Internet access
  • Motivation and psychological stability to stay in a long term obesity intervention
  • No medical conditions prohibiting moderate physical exercise

Exclusion Criteria:

  • Men
  • Age under 18 years
  • BMI under 30 and above 40
  • No Internet access
  • No motivation and psychological stability to stay in a long term obesity intervention
  • Medical conditions prohibiting moderate physical 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: Internet

Participants of this intervention group get follow up support via Internet.

They have access to new inputs biweekly consisting of

  • Thematic inputs and instructions (e.g. advice on shopping, cooking, regular exercise on daily routine, motivation and more)
  • assignments promoting self-awareness and introspection
  • spreadsheets promoting self-monitoring

News and updates (e.g. recipes, gymnastic classes, meetings of self support groups and more) will be available each month.

Tailored feedback of their behaviour will be given by documentation on spreadsheets.

inputs will be based on elements derived from cognitive behavioural therapy, acceptance and commitment therapy, mindfulness and awareness training
Eksperimentel: Printed Manual

Participants of this intervention group get follow up support via a printed manual.

The manual consist of all the same inputs as are available to the Internet follow up group.

  • Thematic inputs and instructions (e.g. advice on shopping, cooking, regular exercise on daily routine, motivation and more)
  • assignments promoting self-awareness and introspection
  • spreadsheets promoting self-monitoring

All inputs will be given at once at the beginning of the follow up intervention, only news and updates (e.g. recipes, gymnastic classes, meetings of self support groups and more) will be sent per mail each month.

There is no tailored feedback of their behaviour as the paper-pencil documentation on spreadsheets can't be monitored by the psychologists.

inputs will be based on elements derived from cognitive behavioural therapy, acceptance and commitment therapy, mindfulness and awareness training

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Changes in nutrition- and exercise self-efficacy
Tidsramme: Primary outcome measure is assessed at the beginning of the follow up support (baseline) and after 6 months (at completion of the follow up intervention by Internet or printed manual)
Changes in nutrition- and exercise self-efficacy will be measured by scores in questionnaires for nutrition- and exercise self-efficacy (Sportbezogene Selbstwirksamkeitserwartung - Fuchs & Schwarzer, 1994 and Weight Efficacy Life-Style Questionnaire - Clark et al. 1991). A change of more than one standard deviation will be considered significant.
Primary outcome measure is assessed at the beginning of the follow up support (baseline) and after 6 months (at completion of the follow up intervention by Internet or printed manual)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Dropout rate
Tidsramme: Secondary outcome measure is assessed at the beginning of the follow up support (baseline) and after 6 months (at completion of the follow up intervention by Internet or printed manual)
The Dropout rate will be compared by the number of women available for the last meeting at the end of the follw up intervention.
Secondary outcome measure is assessed at the beginning of the follow up support (baseline) and after 6 months (at completion of the follow up intervention by Internet or printed manual)

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Sustainability of weight loss
Tidsramme: Further outcome measure is assessed at the beginning of the follow up support (baseline) and after 6 months (at completion of the follow up intervention by Internet or printed manual)

Sustainability will be measured in

  • percentage of women successfully stabilized weight (range of ± 2 kg based on Cooper et al. (2008)
  • percentage of women keeping the scores or impair no more than 1 standard deviation in their test results ("Ad Eva Testsystem zur Diagnostik und Evaluation bei Adipositas" - Ardelt-Gattinger und Meindl, 2009; "Sportbezogene Selbstwirksamkeitserwartung" - Fuchs & Schwarzer, 1994; "Weight Efficacy Life-Style Questionnaire (WEL)" - Clark et al., 1991; "SF 36 - Fragebogen zum Gesundheitszustand" - Bullinger und Kirchberger, 1998)
Further outcome measure is assessed at the beginning of the follow up support (baseline) and after 6 months (at completion of the follow up intervention by Internet or printed manual)

Samarbejdspartnere og efterforskere

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

Sponsor

Efterforskere

  • Ledende efterforsker: Sonja Rader, Mag.a, FEM Süd

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. august 2012

Primær færdiggørelse (Faktiske)

1. september 2014

Studieafslutning (Faktiske)

1. september 2014

Datoer for studieregistrering

Først indsendt

28. august 2012

Først indsendt, der opfyldte QC-kriterier

29. august 2012

Først opslået (Skøn)

30. august 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

9. marts 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. marts 2015

Sidst verificeret

1. marts 2015

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • EK-12-098-VK ID by EC Vienna

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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