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

Sponsor
University of Copenhagen (Other)
Overall Status
Completed
CT.gov ID
NCT01997060
Collaborator
Ubberup Folk High School (Other)
80
1
1
17
4.7

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.

We 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, 12 and 39 months after intervention?

  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 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.

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

Study Design

Study Type:
Interventional
Actual Enrollment :
80 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Physiological Factors That Influence Maintenance of Lifestyle Changes and Weight Loss - a Longitudinal Study
Study Start Date :
Jan 1, 2014
Actual Primary Completion Date :
Jun 1, 2015
Actual Study Completion Date :
Jun 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Behavioral: Intensive Lifestyle Intervention

Outcome Measures

Primary Outcome Measures

  1. Total body weight [Changes from baseline at 3, 6, 15 and 39 months]

Secondary Outcome Measures

  1. Maximal fat oxidation during exercise [Changes from baseline at 3, 6, 15 and 39 months]

    Respiratory Exchange Ratio (RER) is measured and maximal fat oxidation is calculated.

  2. Anthropometry [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.

  3. Maximal Oxygen Consumption [Changes from baseline at 3, 6, 15 and 39 months]

Other Outcome Measures

  1. Adherence to physical activity [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).

  2. Adherence to healthy diet [Changes from baseline at 3, 6, 15 and 39 months]

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

  3. Mitochondria respiration and efficiency [Changes from baseline at 3, 6, 15 and 39 months]

    Mitochondria respiration and efficiency is measured by Oreboros Oxygraph.

  4. Blood and plasma substrates, hormones and metabolites [Changes from baseline at 3, 6, 15 and 39 months]

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

  5. Muscle lipid composition [Changes from baseline at 3, 6, 15 and 39 months]

    Muscle lipid composition will be analysed using a lipidomics approach.

  6. Expression of muscle lipases [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)

  7. Intramuscular lipid droplet content and size, glycogen content and ceramide content and location [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

  8. Adipose tissue macrophage inflammation and cytokine production [Changes from baseline at 3, 6, 15 and 39 months]

  9. Motivation for lifestyle changes and sociological factors involved [Changes from baseline at 3, 6, 15 and 39 months]

    Questionnaires

Eligibility Criteria

Criteria

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

  • BMI<25

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, Associate Professor, University of Copenhagen
ClinicalTrials.gov Identifier:
NCT01997060
Other Study ID Numbers:
  • UBBERUP2
First Posted:
Nov 27, 2013
Last Update Posted:
Feb 1, 2016
Last Verified:
Jan 1, 2016
Keywords provided by Jørn Wulff Helge, Associate Professor, University of Copenhagen
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 1, 2016