Clinical trial NCT01997060: 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
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Overweight
Keywords: Lifestyle intervention
Body weight
Body composition
Weight loss maintenance
Physical activity
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Ubberup Folk High School
First posted: 2013-11-27
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

* Participants at Ubberup Folk High School

Exclusion Criteria:

* Previous Gastric Bypass Surgery or Gastric Banding
* BMI\<25

Primary outcomes:
measure: Total body weight
timeFrame: Changes from baseline at 3, 6, 15 and 39 months
Secondary outcomes:
measure: Maximal fat oxidation during exercise
timeFrame: Changes from baseline at 3, 6, 15 and 39 months
measure: Anthropometry
timeFrame: Changes from baseline at 3, 6, 15 and 39 months
measure: Maximal Oxygen Consumption
timeFrame: Changes from baseline at 3, 6, 15 and 39 months
Other outcomes:
measure: Adherence to physical activity
timeFrame: Changes from baseline at 3, 6, 15 and 39 months
measure: Adherence to healthy diet
timeFrame: Changes from baseline at 3, 6, 15 and 39 months
measure: Mitochondria respiration and efficiency
timeFrame: Changes from baseline at 3, 6, 15 and 39 months
measure: Blood and plasma substrates, hormones and metabolites
timeFrame: Changes from baseline at 3, 6, 15 and 39 months
measure: Muscle lipid composition
timeFrame: Changes from baseline at 3, 6, 15 and 39 months
measure: Expression of muscle lipases
timeFrame: Changes from baseline at 3, 6, 15 and 39 months
measure: Intramuscular lipid droplet content and size, glycogen content and ceramide content and location
timeFrame: Changes from baseline at 3, 6, 15 and 39 months
measure: Adipose tissue macrophage inflammation and cytokine production
timeFrame: Changes from baseline at 3, 6, 15 and 39 months
measure: Motivation for lifestyle changes and sociological factors involved
timeFrame: Changes from baseline at 3, 6, 15 and 39 months
Locations:
city: Copenhagen
country: Denmark
facility: University of Copenhagen, Department of Biomedical Sciences
Study officials:
affiliation: University of Copenhagen, Department of Biomedical Sciences
name: Jørn W Helge, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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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.
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.
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.
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.
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.