NCT01997034

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. 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. 1.Are there physiological traits and characteristics that mediate better adherence to lifestyle changes and weight loss?
  2. 2.Does the adaptation in muscle oxidative capacity after lifestyle intervention predict success in maintaining weight loss and lifestyle changes?
  3. 3.How does gender and age influence the capacity to maintain the lifestyle induced adaptation in muscle and adipose tissue and maintaining weight loss?

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2013

Typical duration for all trials

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

Study Start

First participant enrolled

November 1, 2013

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

November 21, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 27, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

February 1, 2016

Status Verified

January 1, 2016

Enrollment Period

2.1 years

First QC Date

November 21, 2013

Last Update Submit

January 29, 2016

Conditions

Keywords

Weight loss maintenanceBody compositionPhysical activityLifestyle intervention

Outcome Measures

Primary Outcomes (1)

  • Total Body weight

    0-14 years after the intervention is completed

Secondary Outcomes (3)

  • Anthropometry

    0-14 years after the intervention is completed

  • Maximal fat oxidation

    0-14 years after the intervention is completed

  • Maximal Oxygen Consumption

    0-14 years after the intervention is completed

Other Outcomes (9)

  • Adherence to a healthy diet

    0-14 years after the intervention is completed

  • Adherence to physical activity

    0-14 years after the intervention is completed

  • Mitochondria respiration and efficiency

    0-14 years after the intervention is completed

  • +6 more other outcomes

Study Arms (1)

Intensive Lifestyle Intervention

Former participants of Ubberup Folk High Schools intensive lifestyle intervention programme.

Behavioral: Intensive Lifestyle Intervention

Interventions

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.

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 will be included in this study. Ubberup Folk High School is a privately hold externate that teaches lifestyle intervention courses with focus on weight loss. A stay at Ubberup has a duration of 10-14 weeks and is primarily self-financed. The study population will consist of men and women of two different age Groups (18-35 and 35-65yr). We will recruit participants who succeeded in maintaining the weight loss and participants who regained in weight.

You may qualify if:

  • Former participants of Ubberup Folk High School

You may not qualify if:

  • Gastric Bypass Surgery or Gastric 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
  • Elsborg P, Elbe AM. Exercise-specific volition and motivation for weight loss maintenance following an intensive lifestyle intervention. Health Psychol. 2018 Aug;37(8):759-766. doi: 10.1037/hea0000636.

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, muscle and fat tissue.

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
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D., Associate Professor

Study Record Dates

First Submitted

November 21, 2013

First Posted

November 27, 2013

Study Start

November 1, 2013

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

February 1, 2016

Record last verified: 2016-01

Locations