NCT01675713

Brief Summary

The overall purpose of this project is to study the acute, short- (≤ 1 year) and long- (\> 1 year) term effects on body composition and psychological health after a 10 to 14-weeks comprehensive lifestyle modification program for the treatment of severe obesity. The aims of the PhD project are to investigate whether an intensive lifestyle intervention leads to acute and short term (\< 1 year) changes in:

  1. 1.The BMI/Weight
  2. 2.Body composition (waist circumference, fat mass, fat free mass, skeletal muscle mass and visceral fat area)
  3. 3.Psychosocial factors such as eating behavior, anxiety and depression symptoms and health-related quality of life

Trial Health

87
On Track

Trial Health Score

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

Enrollment
149

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2009

Longer than P75 for not_applicable

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

September 1, 2009

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

August 20, 2012

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 30, 2012

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

April 15, 2015

Status Verified

April 1, 2015

Enrollment Period

3.8 years

First QC Date

August 20, 2012

Last Update Submit

April 14, 2015

Conditions

Morbid Obesity

Keywords

LifestylePhysical activity

Outcome Measures

Primary Outcomes (1)

  • Acute and short term (12 months) effects of an intensive 10 to 14-weeks inpatient program with lifestyle modification for the treatment of morbidly obese patients on body composition and psychosocial health

    three years

Secondary Outcomes (29)

  • Body composition

    Week 10-14

  • Body composition

    Week 26

  • Body composition

    Week 52

  • Health related quality of life

    Week 10-14

  • Health related quality of life

    Week 26

  • +24 more secondary outcomes

Study Arms (2)

Lifestyle intervention

EXPERIMENTAL

10-14 weeks intensive lifestyle intervention

Behavioral: Intensive lifestyle intervention

Controls

NO INTERVENTION

No treatment, waiting list

Interventions

Intensive lifestyle interventionBEHAVIORAL

Lifestyle modification program focusing on increasing physical activity level, adjusting energy intake and learning coping strategies

Lifestyle intervention

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • morbidly obese

You may not qualify if:

  • not able to walk slowly for 20 minutes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Norwegian School of Sport Sciences

Oslo, 0806, Norway

Location

Related Publications (3)

  • Maehlum S, Danielsen KK, Heggebo LK, Schioll J. The Hjelp24 NIMI Ringerike obesity clinic: an inpatient programme to address morbid obesity in adults. Br J Sports Med. 2012 Feb;46(2):91-4. doi: 10.1136/bjsm.2010.071894. Epub 2010 May 10.

    PMID: 20460258BACKGROUND

  • Danielsen KK, Sundgot-Borgen J, Maehlum S, Svendsen M. Beyond weight reduction: improvements in quality of life after an intensive lifestyle intervention in subjects with severe obesity. Ann Med. 2014 Aug;46(5):273-82. doi: 10.3109/07853890.2013.874660. Epub 2014 Feb 4.

    PMID: 24491067RESULT

  • 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: 23710347RESULT

MeSH Terms

Conditions

Obesity, MorbidMotor Activity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Sverre Mæhlum, MD, PhD

    Hjelp24

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, PhD

Study Record Dates

First Submitted

August 20, 2012

First Posted

August 30, 2012

Study Start

September 1, 2009

Primary Completion

July 1, 2013

Study Completion

September 1, 2014

Last Updated

April 15, 2015

Record last verified: 2015-04

Locations

NO(1)