NCT02040753

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,120

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 21, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 20, 2014

Completed
12 days until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

February 1, 2016

Status Verified

January 1, 2016

Enrollment Period

1.3 years

First QC Date

November 21, 2013

Last Update Submit

January 29, 2016

Conditions

ObesityOverweight

Keywords

Lifestyle interventionChange of body compositionPhysical activityWeight loss maintenance

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Change in body composition

    Before intervention, after intervention (after 10-14 weeks) and follow up measurements after 1-13 years depending on when the lifestyle intervention took place

Study Arms (1)

Intensive Lifestyle Intervention

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

Behavioral: Intensive Lifestyle Intervention

Interventions

Intensive Lifestyle InterventionBEHAVIORAL

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.

Intensive Lifestyle Intervention

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Former participants of Ubberup Folk High School.

You may qualify if:

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

You may not qualify if:

  • Gastric bypass surgery or banding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Copenhagen, Department of Biomedical Sciences

Copenhagen, 2200, Denmark

Location

Related Publications (8)

  • 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.

    PMID: 24090083BACKGROUND

  • 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.

    PMID: 23801526BACKGROUND

  • 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.

    PMID: 23710347BACKGROUND

  • 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.

    PMID: 16352667BACKGROUND

  • 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.

    PMID: 16403343BACKGROUND

  • 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.

    PMID: 17893261BACKGROUND

  • 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.

    PMID: 17299115BACKGROUND

  • 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.

    PMID: 27720417DERIVED

MeSH Terms

Conditions

ObesityOverweightMotor Activity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Jørn W Helge, PhD

    University of Copenhagen, Department of Biomedical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 21, 2013

First Posted

January 20, 2014

Study Start

February 1, 2014

Primary Completion

June 1, 2015

Study Completion

January 1, 2016

Last Updated

February 1, 2016

Record last verified: 2016-01

Locations

DK(1)