Guidance in Diet and Physical Activity for Prevention of Weight Gain After Gastric Bypass Surgery
22. oktober 2014 opdateret af: Oslo University Hospital
Guidance in Diet and Physical Activity for Prevention of Weight Gain After Gastric Bypass Surgery.
Primary Outcomes:
- To study cross-sectional associations between diet, physical activity, T2DM and weight in subjects 2 yrs after surgery.
To study if subjects receiving extra guidance in diet and physical activity experience less weight gain compared to a control group.
Secondary Outcomes:
- To study the association between vit.D levels and T2DM.
- To study the association between weight change and QOL.
- To validate the new guidance strategy by recording food intake, energy expenditure and physical activity level.
- To study if subjects receiving extra guidance in diet and physical activity experience other health effects compared to a control group.
- To search for biomarkers that can identify people at risk of increasing weight post surgery
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Expected weight loss after GBP is 60-80% of the overweight.
GBP is effective therapy against the obesity-related disorders, including T2DM.
Some subjects start gaining weight within 12-18 months after surgery.
Weight gain may again increase the risk for developing obesity-related disorders.
Previous studies have found a link between vitamin D deficiencies and T2DM.
Vitamin D levels will be monitored during the intervention.
Studies have shown that patients who underwent GBP experienced a dramatic improvement in quality of life(QOL).
After reaching maximum weight loss, many will slowly gain weight.
For some people that means a decrease in QOL.
In order to prevent weight gain it may be useful to provide additional follow-ups.
Participants are randomised into two groups: Group A will receive extra guidance and follow-up, while Group B will continue with the existing scheme.
Participants in Group A will over the next 2 yrs take part in frequent meetings.
To assess dietary habits, physical activity patterns and QOL, food diaries, physical activity questionnaires and QOL questionnaires are used.
Anthropometric and blood pressure measurements will be taken and blood samples will be collected at regular time intervals before and during the study.
The results will be used to validate the effect of extra guidance, and to decide if this treatment shall be offered to all of our patients.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
165
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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Oslo, Norge, 0407
- Oslo University Hospital
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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
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Patients undergoing gastric bypass surgery at OUH in the period January 2006 to June 2009 (recruited 24 ± 9 months following surgery)
- Willingness to participate at regular meetings at OUH
Exclusion Criteria:
- Patients who have experienced serious complications due to the bariatric surgery
- Patients who do not understand Norwegian
- Immobile patients
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Andet: Lifestyle group counseling
Included patients will be randomised into two groups: to the intervention group or to the control group.
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To study if subjects receiving extra guidance in diet and physical activity experience less weight gain compared to a control group.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Weight regain
Tidsramme: 2 and 4 years postsurgery
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2 and 4 years postsurgery
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Changes in QOL, insulin resistance, diabetes, cardiovascular risk factors, nutritional status.
Tidsramme: 2 and 4 years postsurgery
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2 and 4 years postsurgery
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Anne-Marie Aas, Phd, Department of Nutrition & Dietetics, Oslo University Hospital, Aker
- Studieleder: Helga Refsum, Prof.,MD,PhD, Dept. of Nutrition, University of Oslo (UiO)
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. september 2008
Primær færdiggørelse (Faktiske)
1. september 2012
Studieafslutning (Faktiske)
1. september 2012
Datoer for studieregistrering
Først indsendt
4. januar 2011
Først indsendt, der opfyldte QC-kriterier
4. januar 2011
Først opslået (Skøn)
5. januar 2011
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
23. oktober 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
22. oktober 2014
Sidst verificeret
1. oktober 2014
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 08/302d, 2008/6365 (REK)
- 08/7772 (Anden identifikator: Biobankregisteret)
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 .