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

January 29, 2016 updated by: 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:

  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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2200
        • University of Copenhagen, Department of Biomedical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Participants at Ubberup Folk High School

Exclusion Criteria:

  • Previous Gastric Bypass Surgery or Gastric Banding
  • BMI<25

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Total body weight
Time Frame: Changes from baseline at 3, 6, 15 and 39 months
Changes from baseline at 3, 6, 15 and 39 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximal fat oxidation during exercise
Time Frame: 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
Time Frame: 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
Time Frame: Changes from baseline at 3, 6, 15 and 39 months
Changes from baseline at 3, 6, 15 and 39 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence to physical activity
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: Changes from baseline at 3, 6, 15 and 39 months
Questionnaires
Changes from baseline at 3, 6, 15 and 39 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Copenhagen

Collaborators

Ubberup Folk High School

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

November 21, 2013

First Submitted That Met QC Criteria

November 21, 2013

First Posted (Estimate)

November 27, 2013

Study Record Updates

Last Update Posted (Estimate)

February 1, 2016

Last Update Submitted That Met QC Criteria

January 29, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UBBERUP2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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