Physiological Factors That Influence Maintenance of Lifestyle Changes and Weight Loss - a Longitudinal Study
29. januar 2016 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
80
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
-
Copenhagen, Danmark, 2200
- University of Copenhagen, Department of Biomedical Sciences
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 65 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Participants at Ubberup Folk High School
Exclusion Criteria:
- Previous Gastric Bypass Surgery or Gastric Banding
- BMI<25
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Total body weight
Tidsramme: Changes from baseline at 3, 6, 15 and 39 months
|
Changes from baseline at 3, 6, 15 and 39 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Maximal fat oxidation during exercise
Tidsramme: Changes from baseline at 3, 6, 15 and 39 months
|
Respiratory Exchange Ratio (RER) is measured and maximal fat oxidation is calculated.
|
Changes from baseline at 3, 6, 15 and 39 months
|
|
Anthropometry
Tidsramme: Changes from baseline at 3, 6, 15 and 39 months
|
Body composition measured by dual x-ray absorptiometry or bio-impedance, height, weight, waist circumference.
|
Changes from baseline at 3, 6, 15 and 39 months
|
|
Maximal Oxygen Consumption
Tidsramme: Changes from baseline at 3, 6, 15 and 39 months
|
Changes from baseline at 3, 6, 15 and 39 months
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Adherence to physical activity
Tidsramme: Changes from baseline at 3, 6, 15 and 39 months
|
International Physical Activity Questionaire (IPAQ) to determine adherence to physical activity.
Furthermore we will use diary and ActiHeart (accelerometer).
|
Changes from baseline at 3, 6, 15 and 39 months
|
|
Adherence to healthy diet
Tidsramme: Changes from baseline at 3, 6, 15 and 39 months
|
Questionnaire (24hrs dietary recall) and diary to determine adherence to a healthy diet.
|
Changes from baseline at 3, 6, 15 and 39 months
|
|
Mitochondria respiration and efficiency
Tidsramme: Changes from baseline at 3, 6, 15 and 39 months
|
Mitochondria respiration and efficiency is measured by Oreboros Oxygraph.
|
Changes from baseline at 3, 6, 15 and 39 months
|
|
Blood and plasma substrates, hormones and metabolites
Tidsramme: Changes from baseline at 3, 6, 15 and 39 months
|
HbA1c, insulin, leptin, glucose, adiponectin, thyroid stimulating hormone (TSH), ghrelin
|
Changes from baseline at 3, 6, 15 and 39 months
|
|
Muscle lipid composition
Tidsramme: Changes from baseline at 3, 6, 15 and 39 months
|
Muscle lipid composition will be analysed using a lipidomics approach.
|
Changes from baseline at 3, 6, 15 and 39 months
|
|
Expression of muscle lipases
Tidsramme: Changes from baseline at 3, 6, 15 and 39 months
|
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)
|
Changes from baseline at 3, 6, 15 and 39 months
|
|
Intramuscular lipid droplet content and size, glycogen content and ceramide content and location
Tidsramme: Changes from baseline at 3, 6, 15 and 39 months
|
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
|
Changes from baseline at 3, 6, 15 and 39 months
|
|
Adipose tissue macrophage inflammation and cytokine production
Tidsramme: Changes from baseline at 3, 6, 15 and 39 months
|
Changes from baseline at 3, 6, 15 and 39 months
|
|
|
Motivation for lifestyle changes and sociological factors involved
Tidsramme: Changes from baseline at 3, 6, 15 and 39 months
|
Questionnaires
|
Changes from baseline at 3, 6, 15 and 39 months
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Jørn W Helge, PhD, University of Copenhagen, Department of Biomedical Sciences
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. januar 2014
Primær fullføring (Faktiske)
1. juni 2015
Studiet fullført (Faktiske)
1. juni 2015
Datoer for studieregistrering
Først innsendt
21. november 2013
Først innsendt som oppfylte QC-kriteriene
21. november 2013
Først lagt ut (Anslag)
27. november 2013
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
1. februar 2016
Siste oppdatering sendt inn som oppfylte QC-kriteriene
29. januar 2016
Sist bekreftet
1. januar 2016
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- UBBERUP2
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .