The Effect of Repeated Lifestyle Intervention on Weight Loss Maintenance

Obesity Clinical Trial

Official title:

The Effect of Repeated Lifestyle Intervention on Weight Loss Maintenance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02040753
• Other study ID #: UBBERUP1
• Status: Completed
• Phase: N/A
• First received: November 21, 2013
• Last updated: January 29, 2016
• Start date: February 2014
• Est. completion date: January 2016

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.

In this study we will analyse the results of the intensive lifestyle intervention as it has been practised at Ubberup Folk High School over the last 13 years. As some people have several stays at Ubberup Folk High School we want to we have a special interest in the effect of repeated lifestyle intervention.

Research question:

What is the effect of several lifestyle interventions on weight loss maintenance?

The study design is retrospective and descriptive and will be based on a lifestyle intervention, as it has practiced in a real life setting at Ubberup folk high school.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2120
• Est. completion date: January 2016
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Former participants of the intensive lifestyle intervention at Ubberup Folk High School.

Exclusion Criteria:

• Gastric bypass surgery or banding

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Obesity
• Overweight
• Weight Loss

Intervention

Behavioral:
• Intensive Lifestyle Intervention
Intensive Lifestyle intervention at Ubberup Folk High School for 10-14 weeks. Daily exercise for 1-3hrs. Calorie restriction. Education within Nutrition, exercise and healthy living in general.

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
Primary	Change in total body weight		Before intervention, after intervention (after 10-14 weeks) and follow up measurements after 1-13 years depending on when the lifestyle intervention took place	No
Secondary	Change in body composition	Measured by bio-impedance.	Before intervention, after intervention (after 10-14 weeks) and follow up measurements after 1-13 years depending on when the lifestyle intervention took place	No

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