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The Effect of a Multi-component Weight Management Program on Appetite, Food Preference and Body Weight (SWSS)

31. maj 2017 opdateret af: Dr Graham Finlayson, University of Leeds

The aim of the current study is to demonstrate that a commercial weight management diet (i.e. low energy density) influences satiation, hunger and satiety and leads to lower energy intake during ad-libitum meals and over a full day. We further seek to demonstrate the sustainability of this effect following 12- week weight loss on the weight management program.

  • We hypothesise that formulated (low energy) meals will lead to decreased hunger, greater fullness and reduced desire to eat compared to standard meals.
  • We hypothesise that the commercial weight management program will lead to greater weight loss compared to control program.
  • We hypothesise that formulated meals (high consumer acceptance) will improve hedonic control over eating (lower wanting for high fat food)
  • We hypothesise that the commercial weight management program will improve hedonic control over eating (reduced experience food cravings)

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

96

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Det Forenede Kongerige
    • West Yorkshire
      • Leeds, West Yorkshire, Det Forenede Kongerige, LS2 9JT
        • University of Leeds

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 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

Inclusion Criteria:

  • BMI of 28 - 45 kg/m2
  • Reporting an interest in weight loss, not actively participating in a commercial weight loss program,
  • Not increased physical activity levels in the past 2-4 weeks
  • Able to eat most everyday foods and fruits and vegetables
  • Written informed consent to be given

Exclusion Criteria:

  • Significant health problems that could cause confounding effects between intervention and control.
  • Taking any medication or supplements known to affect appetite or weight within the past month and/or during the study
  • Pregnant, planning to become pregnant or breastfeeding
  • History of anaphylaxis to food
  • Known food allergies or food intolerance
  • Smokers and those who have recently ceased smoking
  • Participants receiving systemic or local treatment likely to interfere with evaluation of the study parameters
  • Those who have previously taken part in a commercial weight loss program in the last 6 months? .
  • Participants who work in appetite or feeding related areas
  • Participants unable to consume foods used in the study
  • Participants who have had bariatric surgery
  • Participants with a history of eating disorder
  • Presence of untreated hypothyroidism
  • Inability to fully comply with intervention or study procedures
  • Insufficient English language skills to complete study questionnaires

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Grundvidenskab
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Intervention Group
Participants enrolled in commercial weight management program
Adfærdsmæssigt: Weight management program
Aktiv komparator: Control group
Participants enrolled in standard care weight management provision
Adfærdsmæssigt: Weight management program

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Test Meal Energy Intake
Tidsramme: Week 0 and week 12
Measured reductions in ad-libitum energy intake following consumption of formulated test meal in comparison to control.
Week 0 and week 12
24h Energy Intake
Tidsramme: Week 0 and week 12
Measured reduction in total within-day energy intake following consumption of formulated meals in comparison to control
Week 0 and week 12
Appetite sensations
Tidsramme: Week 0 and week 14
Measured reduction in hunger and increase in satiety quotient following consumption of formulated test meal in comparison to equi-energetic control
Week 0 and week 14
Food preference
Tidsramme: Week 0 and week 14
Measured changes in food preference and liking and wanting profiles for food (HF<LF) following consumption of formulated test meal in comparison to equi-energetic control
Week 0 and week 14

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Body Weight
Tidsramme: Weekly from week 0 to week 12
Measured change in weight and energy balance parameters over a 12 week period following participation in commercial weight management program compared to control group.
Weekly from week 0 to week 12

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Food diary
Tidsramme: Week 0 and week 12
Intervention adherence and compensation through 1) food diary analysis.
Week 0 and week 12
Accelerometer
Tidsramme: Week 0 and week 12
Intervention adherence and compensation through accelerometer analysis.
Week 0 and week 12
Interview
Tidsramme: Week 12
Detailed feedback on participant experience of commercial weight management program through qualitative interview and marketing survey.
Week 12

Samarbejdspartnere og efterforskere

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

Sponsor

University of Leeds

Efterforskere

  • Ledende efterforsker: Graham S Finlayson, PhD, University of Leeds

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.

Generelle publikationer

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. januar 2014

Primær færdiggørelse (Faktiske)

1. december 2015

Studieafslutning (Faktiske)

1. maj 2016

Datoer for studieregistrering

Først indsendt

10. december 2013

Først indsendt, der opfyldte QC-kriterier

10. december 2013

Først opslået (Skøn)

16. december 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

1. juni 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

31. maj 2017

Sidst verificeret

1. maj 2017

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • LDS-2013-SLW
  • KRISTAL No. (Anden identifikator: RG.PSYC.100944)

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 management program

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Sponsorer og samarbejdspartnere

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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