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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01997034
• Other study ID #: UBBERUP 3
• Status: Completed
• Phase: N/A
• First received: November 21, 2013
• Last updated: January 29, 2016
• Start date: November 2013
• Est. completion date: December 2015

Study information

• Verified date: January 2016
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Former participants of Ubberup Folk High School

Exclusion Criteria:

• Gastric Bypass Surgery or Gastric Banding

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Obesity
• Overweight
• Weight Loss

Intervention

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.

Locations

Country	Name	City	State
Denmark	University of Copenhagen, Department of Biomedical Sciences	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
University of Copenhagen	Ubberup Folk High School

Country where clinical trial is conducted

Denmark, 

References & Publications (7)

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. Epub 2005 Dec 13. — View 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. — View 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. — View Citation

Danielsen KK, Svendsen M, Mæhlum 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. — View Citation

Karlsen TI, Søhagen M, Hjelmesæth 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. — View 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. — View Citation

Pedersen JØ, 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adherence to a healthy diet	Questionnaire (24hrs dietary recall) and diary to determine adherence to a healthy diet	0-14 years after the intervention is completed	No
Other	Adherence to physical activity	International Physical Activity Questionnaire (IPAQ) to determine adherence to physical activity. Furthermore we will use diary and ActiHeart (accelerometer).	0-14 years after the intervention is completed	No
Other	Mitochondria respiration and efficiency	Mitochondria respiration and efficiency measured by Oreboros Oxygraph	0-14 years after the intervention is completed	No
Other	Blood and plasma substrates, hormones and metabolites	HbA1c, insulin, leptin, glucose, adiponectin, thyroid stimulating hormone (TSH), Ghrelin.	0-14 years after the intervention is completed	No
Other	Muscle lipid composition	Muscle lipid composition will be analyzed using a lipidomics approach.	0-14 years after the intervention is completed	No
Other	Expression of muscle lipases	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)	0-14 years after the intervention is completed	No
Other	Adipose tissue macrophage inflammation and cytokine production		0-14 years after the intervention is completed	No
Other	Intramuscular lipid droplet content and size, glycogen content and ceramide content and location	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	0-14 years after the intervention is completed	No
Other	Motivation for lifestyle changes and sociological factors involved	Questionnaires	0-14 years after the intervention is completed	No
Primary	Total Body weight		0-14 years after the intervention is completed	No
Secondary	Anthropometry	Body composition measured by dual x-ray absorptiometry or bio-impedance, height, weight, waist circumference.	0-14 years after the intervention is completed	No
Secondary	Maximal fat oxidation	Respiratoric Exchange Ratio (RER) is measured during an incremental cycling test and maximal fat oxidation is calculated	0-14 years after the intervention is completed	No
Secondary	Maximal Oxygen Consumption		0-14 years after the intervention is completed	No

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