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

Primary Purpose

Obesity, Overweight

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Intensive Lifestyle Intervention
Sponsored by
University of Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity focused on measuring Lifestyle intervention, Body weight, Body composition, Weight loss maintenance, Physical activity

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Participants at Ubberup Folk High School

Exclusion Criteria:

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

Sites / Locations

  • University of Copenhagen, Department of Biomedical Sciences

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intensive Lifestyle Intervention

Arm Description

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.

Outcomes

Primary Outcome Measures

Total body weight

Secondary Outcome Measures

Maximal fat oxidation during exercise
Respiratory Exchange Ratio (RER) is measured and maximal fat oxidation is calculated.
Anthropometry
Body composition measured by dual x-ray absorptiometry or bio-impedance, height, weight, waist circumference.
Maximal Oxygen Consumption

Full Information

First Posted
November 21, 2013
Last Updated
January 29, 2016
Sponsor
University of Copenhagen
Collaborators
Ubberup Folk High School
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1. Study Identification

Unique Protocol Identification Number
NCT01997060
Brief Title
Physiological Factors That Influence Maintenance of Lifestyle Changes and Weight Loss - a Longitudinal Study
Official Title
Physiological Factors That Influence Maintenance of Lifestyle Changes and Weight Loss - a Longitudinal Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Copenhagen
Collaborators
Ubberup Folk High School

4. Oversight

Data Monitoring Committee
Yes

5. 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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Overweight
Keywords
Lifestyle intervention, Body weight, Body composition, Weight loss maintenance, Physical activity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intensive Lifestyle Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Intensive Lifestyle Intervention
Primary Outcome Measure Information:
Title
Total body weight
Time Frame
Changes from baseline at 3, 6, 15 and 39 months
Secondary Outcome Measure Information:
Title
Maximal fat oxidation during exercise
Description
Respiratory Exchange Ratio (RER) is measured and maximal fat oxidation is calculated.
Time Frame
Changes from baseline at 3, 6, 15 and 39 months
Title
Anthropometry
Description
Body composition measured by dual x-ray absorptiometry or bio-impedance, height, weight, waist circumference.
Time Frame
Changes from baseline at 3, 6, 15 and 39 months
Title
Maximal Oxygen Consumption
Time Frame
Changes from baseline at 3, 6, 15 and 39 months
Other Pre-specified Outcome Measures:
Title
Adherence to physical activity
Description
International Physical Activity Questionaire (IPAQ) to determine adherence to physical activity. Furthermore we will use diary and ActiHeart (accelerometer).
Time Frame
Changes from baseline at 3, 6, 15 and 39 months
Title
Adherence to healthy diet
Description
Questionnaire (24hrs dietary recall) and diary to determine adherence to a healthy diet.
Time Frame
Changes from baseline at 3, 6, 15 and 39 months
Title
Mitochondria respiration and efficiency
Description
Mitochondria respiration and efficiency is measured by Oreboros Oxygraph.
Time Frame
Changes from baseline at 3, 6, 15 and 39 months
Title
Blood and plasma substrates, hormones and metabolites
Description
HbA1c, insulin, leptin, glucose, adiponectin, thyroid stimulating hormone (TSH), ghrelin
Time Frame
Changes from baseline at 3, 6, 15 and 39 months
Title
Muscle lipid composition
Description
Muscle lipid composition will be analysed using a lipidomics approach.
Time Frame
Changes from baseline at 3, 6, 15 and 39 months
Title
Expression of muscle lipases
Description
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)
Time Frame
Changes from baseline at 3, 6, 15 and 39 months
Title
Intramuscular lipid droplet content and size, glycogen content and ceramide content and location
Description
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
Time Frame
Changes from baseline at 3, 6, 15 and 39 months
Title
Adipose tissue macrophage inflammation and cytokine production
Time Frame
Changes from baseline at 3, 6, 15 and 39 months
Title
Motivation for lifestyle changes and sociological factors involved
Description
Questionnaires
Time Frame
Changes from baseline at 3, 6, 15 and 39 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Participants at Ubberup Folk High School Exclusion Criteria: Previous Gastric Bypass Surgery or Gastric Banding BMI<25
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jørn W Helge, PhD
Organizational Affiliation
University of Copenhagen, Department of Biomedical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Copenhagen, Department of Biomedical Sciences
City
Copenhagen
ZIP/Postal Code
2200
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
24090083
Citation
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.
Results Reference
background
PubMed Identifier
23801526
Citation
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.
Results Reference
background
PubMed Identifier
23710347
Citation
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.
Results Reference
background
PubMed Identifier
16352667
Citation
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.
Results Reference
background
PubMed Identifier
16403343
Citation
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.
Results Reference
background
PubMed Identifier
17893261
Citation
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.
Results Reference
background
PubMed Identifier
17299115
Citation
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.
Results Reference
background
PubMed Identifier
30024231
Citation
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.
Results Reference
derived

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

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