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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01997060
• Other study ID #: UBBERUP2
• Status: Completed
• Phase: N/A
• First received: November 21, 2013
• Last updated: January 29, 2016
• Start date: January 2014
• Est. completion date: June 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: Interventional

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.

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.

Recruitment information / eligibility

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

Eligibility

Inclusion Criteria:

• Participants at Ubberup Folk High School

Exclusion Criteria:

• Previous Gastric Bypass Surgery or Gastric Banding

• BMI<25

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Obesity
• Overweight
• Weight Loss

Intervention

Behavioral:
• Intensive Lifestyle Intervention

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 physical activity	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	No
Other	Adherence to healthy diet	Questionnaire (24hrs dietary recall) and diary to determine adherence to a healthy diet.	Changes from baseline at 3, 6, 15 and 39 months	No
Other	Mitochondria respiration and efficiency	Mitochondria respiration and efficiency is measured by Oreboros Oxygraph.	Changes from baseline at 3, 6, 15 and 39 months	No
Other	Blood and plasma substrates, hormones and metabolites	HbA1c, insulin, leptin, glucose, adiponectin, thyroid stimulating hormone (TSH), ghrelin	Changes from baseline at 3, 6, 15 and 39 months	No
Other	Muscle lipid composition	Muscle lipid composition will be analysed using a lipidomics approach.	Changes from baseline at 3, 6, 15 and 39 months	No
Other	Expression of muscle lipases	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	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 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	No
Other	Adipose tissue macrophage inflammation and cytokine production		Changes from baseline at 3, 6, 15 and 39 months	No
Other	Motivation for lifestyle changes and sociological factors involved	Questionnaires	Changes from baseline at 3, 6, 15 and 39 months	No
Primary	Total body weight		Changes from baseline at 3, 6, 15 and 39 months	No
Secondary	Maximal fat oxidation during exercise	Respiratory Exchange Ratio (RER) is measured and maximal fat oxidation is calculated.	Changes from baseline at 3, 6, 15 and 39 months	No
Secondary	Anthropometry	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	No
Secondary	Maximal Oxygen Consumption		Changes from baseline at 3, 6, 15 and 39 months	No

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