Analysis of Changes in Eating Habits on Post Bariatric Surgery Patients and Their Family Members (SOCIOB)
18. juni 2019 opdateret af: Assistance Publique - Hôpitaux de Paris
Analysis of Changes in Eating Behaviors and Physical Activity on Post Bariatric Surgery Patients and Their Family Members : Comparison Between Men and Women
The main objective of this study is to identify changes in eating behaviors and physical activity in patients after bariatric surgery and their family members living in same household: children aged between 11-17 years, spouse, parents, cohabitee or partner in a civil union.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
As secondary objectives, the study aims to:
- Describe the sociodemographic and clinical characteristics of post bariatric surgery patients.
- Assess changes in quality of life of the post-surgery patients.
- Explain changes of post-surgery in eating behavior and activity varied according to gender
- Explain changes of post-surgery in eating behavior and activity varied according to socio-economic conditions
- Explain changes of post-surgery in eating behavior and activity varied according to inter-generational relation
- Have a overview on the surgery as a turning point in the life of patients
- Estimate the relevant message of cares given to patients, in order to better adjust medical intervention, in conjunction with patients and their family members.
This is a prospective observational study. It will be performed in two university hospitals: CHU Ambroise Paré at Boulogne-Billancourt city and CHU Pitié Salpétrière at Paris, in nutrition department and metabolic surgery department. The study will involve collaboration of a team of social researchers.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
96
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Hauts Des Seine
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Boulogne Billancourt, Hauts Des Seine, Frankrig, 92100
- Department of Nutrition, CHU Ambroise Paré
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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
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
Patients who will undergo bariatric surgery (bypass or sleeve) and live together with their families.
Beskrivelse
Inclusion Criteria:
- Aged ≥ 18 years
- Eligible to undergo bariatric surgery
- Post bariatric surgery follow-up visits will take place in the nutrition department
- Living together with family member (children aged 11-17 years, parents, spouse, cohabitee or partner in civil union)
- Informed consent signed
Exclusion Criteria:
- Higher-order cognitive disorders
- Language difficulties in understanding
- Living alone or living without any family member
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Changes from baseline in different eating habits and culinary items in responses to questionnaires
Tidsramme: At 3 month, 6 month and 12 month
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Changes from baseline in different eating habits and culinary items in responses to questionnaires at 3 months, 6 months and 1 year after bariatric surgery.
It is expected that patient's feeding practice should be in accordance with the postsurgical dietary guidelines.
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At 3 month, 6 month and 12 month
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Changes from baseline in different items about physical activity in responses to questionnaires
Tidsramme: At 3 month, 6 month and 12 month
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Changes from baseline in different items about physical activity in responses to questionnaires at 3 months, 6 months and 1 year after bariatric surgery.
It is expected that patient's physical activity practice should be in accordance with the postsurgical guidelines.
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At 3 month, 6 month and 12 month
|
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Quality of life measured by scores
Tidsramme: At baseline, 3 month, 6 month and 12 month
|
Quality of life will be measured by scores at baseline, 3 month, 6 month and 12 month
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At baseline, 3 month, 6 month and 12 month
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Sébastien Czernichow, MD, PhD, CHU Ambroise Paré
- Studieleder: Kàtia Lurbe-Puerto, PhD, CHU Ambroise Paré
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 (Faktiske)
1. marts 2015
Primær færdiggørelse (Faktiske)
1. februar 2019
Studieafslutning (Faktiske)
1. juni 2019
Datoer for studieregistrering
Først indsendt
17. marts 2015
Først indsendt, der opfyldte QC-kriterier
27. april 2015
Først opslået (Skøn)
30. april 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
19. juni 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
18. juni 2019
Sidst verificeret
1. juni 2019
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 13SCW-SOCIOB
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 .