Clinical trial NCT02040753: The Effect of Repeated Lifestyle Intervention on Weight Loss Maintenance
Official title: The Effect of Repeated Lifestyle Intervention on Weight Loss Maintenance
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Overweight
Keywords: Lifestyle intervention
Change of body composition
Physical activity
Weight loss maintenance
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Ubberup Folk High School
First posted: 2014-01-20
Enrollment: 2120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Former participants of Ubberup Folk High School.

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.

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Gastric bypass surgery or banding

Primary outcomes:
measure: Change in total body weight
timeFrame: Before intervention, after intervention (after 10-14 weeks) and follow up measurements after 1-13 years depending on when the lifestyle intervention took place
Secondary outcomes:
measure: Change in body composition
timeFrame: Before intervention, after intervention (after 10-14 weeks) and follow up measurements after 1-13 years depending on when the lifestyle intervention took place
Other outcomes:
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.
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.
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: Dandanell S, Skovborg C, Praest CB, Kristensen KB, Nielsen MG, Lionett S, Jorgensen SD, Vigelso A, Dela F, Helge JW. Maintaining a clinical weight loss after intensive lifestyle intervention is the key to cardiometabolic health. Obes Res Clin Pract. 2017 Jul-Aug;11(4):489-498. doi: 10.1016/j.orcp.2016.09.009. Epub 2016 Oct 5.