Physiological Factors That Influence Maintenance of Lifestyle Changes and Weight Loss - a Longitudinal Study
29. januar 2016 opdateret af: Jørn Wulff Helge, University of Copenhagen
In Denmark and the western world, there is an increasing prevalence of obesity probably due to a combination of inadequate daily physical activity and a high energy intake. One approach to achieve weight loss and change life style is to participate in an intensive supervised prolonged life style modification course. The immediate effect is often positive, but over time the overall effect is limited as the majority will not maintain weight loss and a changed life style.
The purpose of this study is therefore to characterize the physiological factors that determine/influence the capacity to maintain weight loss and a healthy lifestyle after a prolonged lifestyle intervention.
We have the following research questions:
- Are there physiological traits and characteristics that mediate better adherence to lifestyle changes and weight loss?
- Does the adaptation in muscle oxidative capacity after lifestyle intervention predict success in maintaining weight loss and lifestyle changes 3, 12 and 39 months after intervention?
- How does gender and age influence the capacity to maintain the lifestyle induced adaptation in muscle and adipose tissue and maintaining weight loss?
The study design is a longitudinal intervention and will be based on a lifestyle intervention, as it is practiced in a real life setting at Ubberup folk high school.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
80
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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Copenhagen, Danmark, 2200
- University of Copenhagen, Department of Biomedical Sciences
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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 til 65 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Participants at Ubberup Folk High School
Exclusion Criteria:
- Previous Gastric Bypass Surgery or Gastric Banding
- BMI<25
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: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Intensive Lifestyle Intervention
Intensive Lifestyle Intervention at Ubberup Folk High School for 10-14 weeks.
Daily exercise for 1-3hrs.
Calorie restriction (~-700KCal/day).
Education within nutrition, exercise and healthy living in general.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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Total body weight
Tidsramme: Changes from baseline at 3, 6, 15 and 39 months
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Changes from baseline at 3, 6, 15 and 39 months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Maximal fat oxidation during exercise
Tidsramme: Changes from baseline at 3, 6, 15 and 39 months
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Respiratory Exchange Ratio (RER) is measured and maximal fat oxidation is calculated.
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Changes from baseline at 3, 6, 15 and 39 months
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Anthropometry
Tidsramme: Changes from baseline at 3, 6, 15 and 39 months
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Body composition measured by dual x-ray absorptiometry or bio-impedance, height, weight, waist circumference.
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Changes from baseline at 3, 6, 15 and 39 months
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Maximal Oxygen Consumption
Tidsramme: Changes from baseline at 3, 6, 15 and 39 months
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Changes from baseline at 3, 6, 15 and 39 months
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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Adherence to physical activity
Tidsramme: Changes from baseline at 3, 6, 15 and 39 months
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International Physical Activity Questionaire (IPAQ) to determine adherence to physical activity.
Furthermore we will use diary and ActiHeart (accelerometer).
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Changes from baseline at 3, 6, 15 and 39 months
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Adherence to healthy diet
Tidsramme: Changes from baseline at 3, 6, 15 and 39 months
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Questionnaire (24hrs dietary recall) and diary to determine adherence to a healthy diet.
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Changes from baseline at 3, 6, 15 and 39 months
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Mitochondria respiration and efficiency
Tidsramme: Changes from baseline at 3, 6, 15 and 39 months
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Mitochondria respiration and efficiency is measured by Oreboros Oxygraph.
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Changes from baseline at 3, 6, 15 and 39 months
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Blood and plasma substrates, hormones and metabolites
Tidsramme: Changes from baseline at 3, 6, 15 and 39 months
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HbA1c, insulin, leptin, glucose, adiponectin, thyroid stimulating hormone (TSH), ghrelin
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Changes from baseline at 3, 6, 15 and 39 months
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Muscle lipid composition
Tidsramme: Changes from baseline at 3, 6, 15 and 39 months
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Muscle lipid composition will be analysed using a lipidomics approach.
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Changes from baseline at 3, 6, 15 and 39 months
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Expression of muscle lipases
Tidsramme: Changes from baseline at 3, 6, 15 and 39 months
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Western blot analysis will be applied to analyse expression of muscle lipases; hormone sensitive lipase (HSL), adipose triglyceride lipase (ATGL) and lipoprotein lipase (LPL) as well as muscle PAT proteins; PLIN 2 (ADRP), PLIN 3 (TIP47) and PLIN 5 (OXPAT)
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Changes from baseline at 3, 6, 15 and 39 months
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Intramuscular lipid droplet content and size, glycogen content and ceramide content and location
Tidsramme: Changes from baseline at 3, 6, 15 and 39 months
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Intramuscular lipid droplet content and size, glycogen content and ceramide content and location will be quantified by immunohistochemical staining of serial cryo-sections of muscle tissue samples that are visualized by confocal microscopy
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Changes from baseline at 3, 6, 15 and 39 months
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Adipose tissue macrophage inflammation and cytokine production
Tidsramme: Changes from baseline at 3, 6, 15 and 39 months
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Changes from baseline at 3, 6, 15 and 39 months
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Motivation for lifestyle changes and sociological factors involved
Tidsramme: Changes from baseline at 3, 6, 15 and 39 months
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Questionnaires
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Changes from baseline at 3, 6, 15 and 39 months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Jørn W Helge, PhD, University of Copenhagen, Department of Biomedical Sciences
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
- Karlsen TI, Sohagen M, Hjelmesaeth J. Predictors of weight loss after an intensive lifestyle intervention program in obese patients: a 1-year prospective cohort study. Health Qual Life Outcomes. 2013 Oct 3;11:165. doi: 10.1186/1477-7525-11-165.
- McCormack SE, McCarthy MA, Harrington SG, Farilla L, Hrovat MI, Systrom DM, Thomas BJ, Torriani M, McInnis K, Grinspoon SK, Fleischman A. Effects of exercise and lifestyle modification on fitness, insulin resistance, skeletal muscle oxidative phosphorylation and intramyocellular lipid content in obese children and adolescents. Pediatr Obes. 2014 Aug;9(4):281-91. doi: 10.1111/j.2047-6310.2013.00180.x. Epub 2013 Jun 25.
- Danielsen KK, Svendsen M, Maehlum S, Sundgot-Borgen J. Changes in body composition, cardiovascular disease risk factors, and eating behavior after an intensive lifestyle intervention with high volume of physical activity in severely obese subjects: a prospective clinical controlled trial. J Obes. 2013;2013:325464. doi: 10.1155/2013/325464. Epub 2013 Apr 22.
- Bruun JM, Helge JW, Richelsen B, Stallknecht B. Diet and exercise reduce low-grade inflammation and macrophage infiltration in adipose tissue but not in skeletal muscle in severely obese subjects. Am J Physiol Endocrinol Metab. 2006 May;290(5):E961-7. doi: 10.1152/ajpendo.00506.2005. Epub 2005 Dec 13.
- Pedersen JO, Zimmermann E, Stallknecht BM, Bruun JM, Kroustrup JP, Larsen JF, Helge JW. [Lifestyle intervention in the treatment of severe obesity]. Ugeskr Laeger. 2006 Jan 9;168(2):167-72. Danish.
- Bruun JM, Stallknecht B, Helge JW, Richelsen B. Interleukin-18 in plasma and adipose tissue: effects of obesity, insulin resistance, and weight loss. Eur J Endocrinol. 2007 Oct;157(4):465-71. doi: 10.1530/EJE-07-0206.
- Christiansen T, Bruun JM, Madsen EL, Richelsen B. Weight loss maintenance in severely obese adults after an intensive lifestyle intervention: 2- to 4-year follow-up. Obesity (Silver Spring). 2007 Feb;15(2):413-20. doi: 10.1038/oby.2007.530.
- Elsborg P, Elbe AM. Exercise-specific volition and motivation for weight loss maintenance following an intensive lifestyle intervention. Health Psychol. 2018 Aug;37(8):759-766. doi: 10.1037/hea0000636.
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. juni 2015
Studieafslutning (Faktiske)
1. juni 2015
Datoer for studieregistrering
Først indsendt
21. november 2013
Først indsendt, der opfyldte QC-kriterier
21. november 2013
Først opslået (Skøn)
27. november 2013
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
1. februar 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
29. januar 2016
Sidst verificeret
1. januar 2016
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- UBBERUP2
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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