Skip to content

Lifestyleintervention for the Treatment of Severe Obesity

Intensive Lifestyleintervention for the Treatment of Severe Obesity

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01675713
Enrollment
149
Registered
2012-08-30
Start date
2009-09-30
Completion date
2014-09-30
Last updated
2015-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Morbid Obesity

Keywords

Lifestyle, Physical activity

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

Detailed description

The study is based on data collected from patients at The Hjelp24 NIMI Ringerike Obesity Clinic, which is an inpatient program to address morbid obesity in adults. The study is a non-randomized clinical trial comparing the acute and long-term effects on physical and psychological health of the 10-14-weeks inpatient comprehensive lifestyle modification program for the treatment of morbidly obese patients. In between the inpatient stay, the patients are followed up either by telephone, occasional mail and/or structured / weekly email. In this project we prospectively follow two groups of patient included in the treatment programme in September 2010 and January 2011, respectively. In addition a control group with waiting-list patients is also included in the study, and they were recruited in October-November 2011

Interventions

BEHAVIORALIntensive lifestyle intervention

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

Sponsors

Hjelp24
CollaboratorOTHER
Norwegian School of Sport Sciences
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* morbidly obese

Exclusion criteria

* not able to walk slowly for 20 minutes

Design outcomes

Primary

MeasureTime frame
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 healththree years

Secondary

MeasureTime frameDescription
Health related quality of lifeWeek 10-14Change in Health related quality of life from baseline
Binge EatingWeek 10-14Change in binge eating from baseline
Binge eatingWeek 26Change in binge eating from baseline
AnxietyWeek 10-14Change in anxiety from baseline
DepressionWeek 10-14Change in depression from baseline
Physical ActivityWeek 10-14Change in physical activity from baseline
Body compositionWeek 10-14Change in body composition (body weight, fat mass, fat free mass, visceral fat area) from baseline
Physical fitnessWeek 10-14Change in physical fitness from baseline
Systolic Blood PressureWeek 10-14Change in Systolic Blood Pressure
LipidsWeek 10-14Change in lipids (Total cholestrol, LDL cholestrol, HDL cholestrol and Triglycerides) from baseline
GlucoseWeek 10-14Change in glucose from baseline
Explore the participants experiences with physical activity prior to, during and after the treatment programme2-3 years post treatmentIn depth interviews
Physical activityWeek 26Change in physical activity from baseline

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026