Physiological Factors That Influence Maintenance of Lifestyle Changes and Weight Loss - a Cross-sectional Study

Sponsor
University of Copenhagen (Other)
Overall Status
Completed
CT.gov ID
NCT01997034
Collaborator
Ubberup Folk High School (Other)
80
1
25
3.2

Study Details

Study Description

Brief Summary

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.

The investigators have the following research questions:
  1. Are there physiological traits and characteristics that mediate better adherence to lifestyle changes and weight loss?

  2. Does the adaptation in muscle oxidative capacity after lifestyle intervention predict success in maintaining weight loss and lifestyle changes?

  3. 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 cross-sectional and will be based on a lifestyle intervention, as it is practiced in a real life setting at Ubberup folk high school. The investigators will recruit former participants of this lifestyle style intervention. 50 % who maintained a weight loss and a healthy life style and 50 % who did not.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Intensive Lifestyle Intervention

Study Design

Study Type:
Observational
Actual Enrollment :
80 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
Physiological Factors That Influence Maintenance of Lifestyle Changes and Weight Loss - a Cross-sectional Study
Study Start Date :
Nov 1, 2013
Actual Primary Completion Date :
Dec 1, 2015
Actual Study Completion Date :
Dec 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Intensive Lifestyle Intervention

Former participants of Ubberup Folk High Schools intensive lifestyle intervention programme.

Behavioral: Intensive Lifestyle Intervention
The included subjects has previously participated in the Intensive Lifestyle Intervention intervention at Ubberup Folk High School. This intervention includes daily exercise and a hypocaloric diet (app. -700KCal/day) for 10-14 weeks. Furthermore theoretical and practical education within e.g. Nutrition, exercise and motivational psychology.

Outcome Measures

Primary Outcome Measures

  1. Total Body weight [0-14 years after the intervention is completed]

Secondary Outcome Measures

  1. Anthropometry [0-14 years after the intervention is completed]

    Body composition measured by dual x-ray absorptiometry or bio-impedance, height, weight, waist circumference.

  2. Maximal fat oxidation [0-14 years after the intervention is completed]

    Respiratoric Exchange Ratio (RER) is measured during an incremental cycling test and maximal fat oxidation is calculated

  3. Maximal Oxygen Consumption [0-14 years after the intervention is completed]

Other Outcome Measures

  1. Adherence to a healthy diet [0-14 years after the intervention is completed]

    Questionnaire (24hrs dietary recall) and diary to determine adherence to a healthy diet

  2. Adherence to physical activity [0-14 years after the intervention is completed]

    International Physical Activity Questionnaire (IPAQ) to determine adherence to physical activity. Furthermore we will use diary and ActiHeart (accelerometer).

  3. Mitochondria respiration and efficiency [0-14 years after the intervention is completed]

    Mitochondria respiration and efficiency measured by Oreboros Oxygraph

  4. Blood and plasma substrates, hormones and metabolites [0-14 years after the intervention is completed]

    HbA1c, insulin, leptin, glucose, adiponectin, thyroid stimulating hormone (TSH), Ghrelin.

  5. Muscle lipid composition [0-14 years after the intervention is completed]

    Muscle lipid composition will be analyzed using a lipidomics approach.

  6. Expression of muscle lipases [0-14 years after the intervention is completed]

    Western Blot analyses will be Applied to analyse expression of muscle lipases; hormone sensitive lipase (HSL), adipose triglyceride lipase (ATGL) and lipoprotein lipase (LPL) as well muscle PAT proteins; PLIN 2 (ADRP), PLIN 3 (TIP47) and PLIN5 (OXPAT)

  7. Adipose tissue macrophage inflammation and cytokine production [0-14 years after the intervention is completed]

  8. Intramuscular lipid droplet content and size, glycogen content and ceramide content and location [0-14 years after the intervention is completed]

    Intramuscular lipid droplet content and size, glycogen content and ceramide content and location wil be quantified by immunohistochemical staining of serial cryo-sections of muscle tissue samples that are visualized by confocal microscopy

  9. Motivation for lifestyle changes and sociological factors involved [0-14 years after the intervention is completed]

    Questionnaires

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Former participants of Ubberup Folk High School
Exclusion Criteria:
  • Gastric Bypass Surgery or Gastric Banding

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Copenhagen, Department of Biomedical Sciences Copenhagen Denmark 2200

Sponsors and Collaborators

  • University of Copenhagen
  • Ubberup Folk High School

Investigators

  • Principal Investigator: Jørn W Helge, PhD, University of Copenhagen, Department of Biomedical Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Jørn Wulff Helge, Ph.D., Associate Professor, University of Copenhagen
ClinicalTrials.gov Identifier:
NCT01997034
Other Study ID Numbers:
  • UBBERUP 3
First Posted:
Nov 27, 2013
Last Update Posted:
Feb 1, 2016
Last Verified:
Jan 1, 2016
Keywords provided by Jørn Wulff Helge, Ph.D., Associate Professor, University of Copenhagen
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 1, 2016